Event Programme

19 November - 21 November

Day 1

Pharmtech & Ingredients Official Opening Ceremony

19 November

10:30 - 11:00

Presentation Zone A, Hall 7, Pavillion 2


Add to calendar 11/19/2019 10:30 11/19/2019 11:00 Official Opening Ceremony Presentation Zone A, Hall 7, Pavillion 2 Europe/Moscow

Ceremony

Official Opening Ceremony

Round table discussion: Total readiness for medicine labelling

Place: Presentation Zone A, Hall 7, Pavillion 2
Participation: free, electronic ticket based
Language: Russian

Co-organised with: Association of Russian Pharmaceutical Manufacturers (ARFP)

19 November

12:00 - 14:00

Presentation Zone A, Hall 7, Pavillion 2


Add to calendar 11/19/2019 12:00 11/19/2019 14:00 Total readiness for medicine labelling The event is dedicated to the implementation of the key national project of monitoring the movement of medicines and launching universal medicine labelling from 1 January 2020.
 
The session will cover issues related to the readiness of all parties involved in distributing medicines, the efficiency of the information system for monitoring the movement of medicines, as well as the initial results of labelling and traceability of medicines included in Russia’s Seven Nosologies Programme.
 
Presentation Zone A, Hall 7, Pavillion 2 Europe/Moscow

Round table

Total readiness for medicine labelling

The event is dedicated to the implementation of the key national project of monitoring the movement of medicines and launching universal medicine labelling from 1 January 2020.
 
The session will cover issues related to the readiness of all parties involved in distributing medicines, the efficiency of the information system for monitoring the movement of medicines, as well as the initial results of labelling and traceability of medicines included in Russia’s Seven Nosologies Programme.
 

Round table discussion: Export potential: new growth points

Place: Presentation Zone A, Hall 7, Pavillion 2
Participation: free, electronic ticket based
Language: Russian

Co-organised with: GMP News

19 November

15:00 - 17:00

Presentation Zone A, Hall 7, Pavillion 2


Add to calendar 11/19/2019 15:00 11/19/2019 17:00 Export potential: new growth points Russian pharmaceutical manufacturers are steadily increasing their volumes of exported products. The growth is not rapid, but in general, the positive trend has been maintained for several years. According to the Federal Customs Service of Russia for the period January-May 2019, the volume of medicines exported from Russia amounted to $287.08 million USD (up 6.27% in comparison with the same period in 2018). The majority of medicines exported go to Ukraine, Kazakhstan and Belarus. According to the forecast of the Russian Federation Ministry for Industry and Trade, by 2030, the volume of medicine exports may increase 5 times. This has become one of the missions of the Pharma 2030 strategy, now under development, and the basis of the International Cooperation and Export national project. In this regard, medicine exports are becoming more and more relevant.
However, manufacturers find themselves in a difficult situation. While Russian medicines are in high demand in CIS countries, access to the highly competitive European market is possible only with government support and initiatives.
The round table discussion Export potential: new growth points, organised in partnership with GMP news magazine, will cover the following issues:
 - Opportunities to increase the export of pharmaceutical products
 - The most effective government support measures for manufacturers engaged in or planning to export
 - Priority areas of integrating into the global pharmaceutical market and do Russian companies have the opportunity to occupy their niche?
Representatives of regulators, leading industry experts, and pharmaceutical companies exporting medicines will discuss case studies and will try to address the most pressing questions.
Presentation Zone A, Hall 7, Pavillion 2 Europe/Moscow

Round table

Export potential: new growth points

Russian pharmaceutical manufacturers are steadily increasing their volumes of exported products. The growth is not rapid, but in general, the positive trend has been maintained for several years. According to the Federal Customs Service of Russia for the period January-May 2019, the volume of medicines exported from Russia amounted to $287.08 million USD (up 6.27% in comparison with the same period in 2018). The majority of medicines exported go to Ukraine, Kazakhstan and Belarus. According to the forecast of the Russian Federation Ministry for Industry and Trade, by 2030, the volume of medicine exports may increase 5 times. This has become one of the missions of the Pharma 2030 strategy, now under development, and the basis of the International Cooperation and Export national project. In this regard, medicine exports are becoming more and more relevant.
However, manufacturers find themselves in a difficult situation. While Russian medicines are in high demand in CIS countries, access to the highly competitive European market is possible only with government support and initiatives.
The round table discussion Export potential: new growth points, organised in partnership with GMP news magazine, will cover the following issues:
 - Opportunities to increase the export of pharmaceutical products
 - The most effective government support measures for manufacturers engaged in or planning to export
 - Priority areas of integrating into the global pharmaceutical market and do Russian companies have the opportunity to occupy their niche?
Representatives of regulators, leading industry experts, and pharmaceutical companies exporting medicines will discuss case studies and will try to address the most pressing questions.

Seminars - November, 19

19 November

11:00 - 13:00

Prezentation Zone B, Hall 8, Pavillion 2


Add to calendar 11/19/2019 11:00 11/19/2019 13:00 Seminar by Gluvex: Engineering problems. Yesterday, today, tomorrow Prezentation Zone B, Hall 8, Pavillion 2 Europe/Moscow

Seminars

Seminar by Gluvex: Engineering problems. Yesterday, today, tomorrow

19 November

14:20 - 15:20

Prezentation Zone B, Hall 8, Pavillion 2


Add to calendar 11/19/2019 14:20 11/19/2019 15:20 Seminar by Swiss Business Hub Russia: Swiss innovative technologies in the pharmaceutical production and packaging industry Prezentation Zone B, Hall 8, Pavillion 2 Europe/Moscow

Seminars

Seminar by Swiss Business Hub Russia: Swiss innovative technologies in the pharmaceutical production and packaging industry

Day 2

Discussion session: An effective view on technical support for medicines production

Place: Presentation Zone A, Hall 7, Pavillion 2
Participation: free, electronic ticket based
Language: Russian

Co-organised with: FPT 

Moderator: Grigoriy Peglivanyan, FPT, CEO

Due to the current state of the Russian economy and the decline in purchasing power of medicine users, manufacturers need to take action as soon as possible. Improving operational efficiency is becoming one of the most important tasks in the fight for profitability. Suppliers of equipment and services are also required to respond to this challenge and offer appropriate tools.
Participants of this session will discuss the issue of efficiency at different stages of a pharmaceutical enterprise’s life cycle. Issues of effective manufacturing engineering, including capital and operating costs, operational efficiency and ways to improve it will be discussed. Special attention will be paid to innovative solutions that improve efficiency at different stages of production.

20 November

11:00 - 13:30

Presentation Zone A, Hall 7, Pavillion 2


Add to calendar 11/20/2019 11:00 11/20/2019 13:30 An effective view on technical support for medicines production Due to the current state of the Russian economy and the decline in purchasing power of medicine users, manufacturers need to take action as soon as possible. Improving operational efficiency is becoming one of the most important tasks in the fight for profitability. Suppliers of equipment and services are also required to respond to this challenge and offer appropriate tools.
Participants of this session will discuss the issue of efficiency at different stages of a pharmaceutical enterprise’s life cycle. Issues of effective manufacturing engineering, including capital and operating costs, operational efficiency and ways to improve it will be discussed. Special attention will be paid to innovative solutions that improve efficiency at different stages of production.
Representatives of the manufacturers of technological equipment and medicines - BWT, Marchesini, IMA, FPT – are invited.
Presentation Zone A, Hall 7, Pavillion 2 Europe/Moscow

Discussion session

An effective view on technical support for medicines production

Due to the current state of the Russian economy and the decline in purchasing power of medicine users, manufacturers need to take action as soon as possible. Improving operational efficiency is becoming one of the most important tasks in the fight for profitability. Suppliers of equipment and services are also required to respond to this challenge and offer appropriate tools.
Participants of this session will discuss the issue of efficiency at different stages of a pharmaceutical enterprise’s life cycle. Issues of effective manufacturing engineering, including capital and operating costs, operational efficiency and ways to improve it will be discussed. Special attention will be paid to innovative solutions that improve efficiency at different stages of production.
Representatives of the manufacturers of technological equipment and medicines - BWT, Marchesini, IMA, FPT – are invited.

20 November

11:00 - 13:30

Presentation Zone A, Hall 7, Pavillion 2


Add to calendar 11/20/2019 11:00 11/20/2019 13:30 10 life hacks to increase efficiency at the pharmaceutical production construction phase Presentation Zone A, Hall 7, Pavillion 2 Europe/Moscow

Discussion session

10 life hacks to increase efficiency at the pharmaceutical production construction phase

Speakers

20 November

11:00 - 13:30

Presentation Zone A, Hall 7, Pavillion 2


Add to calendar 11/20/2019 11:00 11/20/2019 13:30 The processes combination in the SDF production as the basis for highly efficient production Presentation Zone A, Hall 7, Pavillion 2 Europe/Moscow

Discussion session

The processes combination in the SDF production as the basis for highly efficient production

Speakers

20 November

11:00 - 13:30

Presentation Zone A, Hall 7, Pavillion 2


Add to calendar 11/20/2019 11:00 11/20/2019 13:30 Effectiveness of Clean utilities and Solution preparation systems at each stage of life cycle Presentation Zone A, Hall 7, Pavillion 2 Europe/Moscow

Discussion session

Effectiveness of Clean utilities and Solution preparation systems at each stage of life cycle

Speakers

20 November

11:00 - 13:30

Presentation Zone A, Hall 7, Pavillion 2


Add to calendar 11/20/2019 11:00 11/20/2019 13:30 Digital Reality is Already Here. Industry 4.0. How do smart machines influence efficiency of production? More speaker details>> Presentation Zone A, Hall 7, Pavillion 2 Europe/Moscow

Discussion session

Digital Reality is Already Here. Industry 4.0. How do smart machines influence efficiency of production?

More speaker details>>

Speakers

20 November

11:00 - 13:30

Presentation Zone A, Hall 7, Pavillion 2


Add to calendar 11/20/2019 11:00 11/20/2019 13:30 Boosting productivity with Uhlmann Tool Management Presentation Zone A, Hall 7, Pavillion 2 Europe/Moscow

Discussion session

Boosting productivity with Uhlmann Tool Management

Speakers

Round table discussion: API production: the economic aspect

Place: Presentation Zone A, Hall 7, Pavillion 2
Participation: free, electronic ticket based
Language: Russian

20 November

14:30 - 16:30

Presentation Zone A, Hall 7, Pavillion 2


Add to calendar 11/20/2019 14:30 11/20/2019 16:30 API production: the economic aspect Despite the decline in the supply of active pharmaceutical ingredients over recent years, financially, imports of APIs continue to grow. One of the key objectives of the Pharma 2030 programme is to provide the pharmaceutical industry with enough in terms of stock and quantity locally produced raw materials, primarily pharmaceutical substances. But there are factors that hinder the production growth of locally produced substances, the main one being the need for large investments, high material intensity and energy intensity of substance production. On the other hand, the resolution regulating public procurement of medicines, which came into force on 1 January 2019, introduced a new type of state support — a price preference of 25% of the minimum contract price. It will apply only to those companies that produce medicines in Russia and the EAEU countries on a full cycle, from the synthesis of the substance to packaging.
How can companies producing their own substances work according to the resolution and what economic benefits they can give? These and other issues will be discussed at the round table discussion API production: the economic aspect, on 20 November at Pharmtech & Ingredients.
Speakers will include representatives of regulatory bodies, leading industry experts, and representatives of API manufacturing companies.
Presentation Zone A, Hall 7, Pavillion 2 Europe/Moscow

Round table

API production: the economic aspect

Despite the decline in the supply of active pharmaceutical ingredients over recent years, financially, imports of APIs continue to grow. One of the key objectives of the Pharma 2030 programme is to provide the pharmaceutical industry with enough in terms of stock and quantity locally produced raw materials, primarily pharmaceutical substances. But there are factors that hinder the production growth of locally produced substances, the main one being the need for large investments, high material intensity and energy intensity of substance production. On the other hand, the resolution regulating public procurement of medicines, which came into force on 1 January 2019, introduced a new type of state support — a price preference of 25% of the minimum contract price. It will apply only to those companies that produce medicines in Russia and the EAEU countries on a full cycle, from the synthesis of the substance to packaging.
How can companies producing their own substances work according to the resolution and what economic benefits they can give? These and other issues will be discussed at the round table discussion API production: the economic aspect, on 20 November at Pharmtech & Ingredients.
Speakers will include representatives of regulatory bodies, leading industry experts, and representatives of API manufacturing companies.

Seminars - November, 20

20 November

11:00 - 12:00

Prezentation Zone B, Hall 8, Pavillion 2


Add to calendar 11/20/2019 11:00 11/20/2019 12:00 Seminar by Asahi Kasei Bioprocess Europe: PLANOVA Virus Removal Filters Prezentation Zone B, Hall 8, Pavillion 2 Europe/Moscow

Seminars

Seminar by Asahi Kasei Bioprocess Europe: PLANOVA Virus Removal Filters

20 November

12:10 - 14:10

Prezentation Zone B, Hall 8, Pavillion 2


Add to calendar 11/20/2019 12:10 11/20/2019 14:10 Seminar by GEA: Centrifuges and package units from GEA for human and veterinary vaccines, starter cultures production, human Blood Plasma Protein fractionation Prezentation Zone B, Hall 8, Pavillion 2 Europe/Moscow

Seminars

Seminar by GEA: Centrifuges and package units from GEA for human and veterinary vaccines, starter cultures production, human Blood Plasma Protein fractionation

20 November

14:20 - 16:20

Prezentation Zone B, Hall 8, Pavillion 2


Add to calendar 11/20/2019 14:20 11/20/2019 16:20 Seminar by PALL: Regulatory Compliance. Are you up-to-date with the latest GMP requirements and biopharmaceutical industry best practices? Prezentation Zone B, Hall 8, Pavillion 2 Europe/Moscow

Seminars

Seminar by PALL: Regulatory Compliance. Are you up-to-date with the latest GMP requirements and biopharmaceutical industry best practices?

Pharmtechprom forum - November, 20

Date: November, 20-21 
Place: Conference Hall L, Hall 7, Pavillion 2
Participation: free, electronic ticket based
Language: Russian

20 November

10:00 - 13:30

Session A – Raw materials and pharmaceutical ingredients. Moderator: Sergey Skvortsov, Elementoorganika (Russia), Managing Director

20 November

10:00 - 10:25

Registration of participants

20 November

10:30 - 11:00

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/20/2019 10:30 11/20/2019 11:00 Liquid and soft drugs formulation development with Super Refined excipients, eliminating instability and impurities issues
  1. Impurities formation in drug formulation
  2. Excipient instability and review of some decomposition products
  3. Impurities influence on API stability
  4. Advantages of drug formulation development driven by Super Refined excipients
Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session A – Raw materials and pharmaceutical ingredients

Liquid and soft drugs formulation development with Super Refined excipients, eliminating instability and impurities issues

  1. Impurities formation in drug formulation
  2. Excipient instability and review of some decomposition products
  3. Impurities influence on API stability
  4. Advantages of drug formulation development driven by Super Refined excipients

Speakers

20 November

11:05 - 11:35

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/20/2019 11:05 11/20/2019 11:35 Pharmaceutical ingredients: optimization of production from press to coater Oral Solid Dosage (OSD) form became increasingly popular in the modern world due to its portability, ease of administration and benefit of creating a formulation even with ingredients which are poorly compatible. However, composition of solid dosage formulation is often quite challenging when it comes to pharmaceutical technology. Therefore, formulators usually face the following questions:
• How to formulate a robust OSD?
• How to achieve uniformity and optimal compactability of tablet mass?
• Which filler is the best for hard gelatin capsules?
• How to switch from wet granulation to direct compression painlessly?
• How to prepare an in-house coating solution to decrease production cost price? Is it possible to prepare functional in-house coatings?
• How to rationally compose an ODT formulation?
In this presentation we will discuss all those questions and even more. The information received will help you optimize the process of manufacturing OSD, therefore you may decrease cost prices and make life easier for you and your company.
Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session A – Raw materials and pharmaceutical ingredients

Pharmaceutical ingredients: optimization of production from press to coater

Oral Solid Dosage (OSD) form became increasingly popular in the modern world due to its portability, ease of administration and benefit of creating a formulation even with ingredients which are poorly compatible. However, composition of solid dosage formulation is often quite challenging when it comes to pharmaceutical technology. Therefore, formulators usually face the following questions:
• How to formulate a robust OSD?
• How to achieve uniformity and optimal compactability of tablet mass?
• Which filler is the best for hard gelatin capsules?
• How to switch from wet granulation to direct compression painlessly?
• How to prepare an in-house coating solution to decrease production cost price? Is it possible to prepare functional in-house coatings?
• How to rationally compose an ODT formulation?
In this presentation we will discuss all those questions and even more. The information received will help you optimize the process of manufacturing OSD, therefore you may decrease cost prices and make life easier for you and your company.

Speakers

20 November

11:40 - 12:10

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/20/2019 11:40 11/20/2019 12:10 Development of mucoadhesive drug delivery systems with Carbopols Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session A – Raw materials and pharmaceutical ingredients

Development of mucoadhesive drug delivery systems with Carbopols

Speakers

20 November

12:15 - 12:45

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/20/2019 12:15 11/20/2019 12:45 Formulators’ tools to meet the requirements of contemporary drugs development When developing generic drugs, especially solid dosage forms, formulators face two conflicting tasks: to provide the market demand (quality and/or price) and make the development in a way of copy-paste. But how often these copy-paste formulations meet the market demands? Not very often.
What tools formulators have to meet both conflicting parties. How to meet the demands of the market and development.
Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session A – Raw materials and pharmaceutical ingredients

Formulators’ tools to meet the requirements of contemporary drugs development

When developing generic drugs, especially solid dosage forms, formulators face two conflicting tasks: to provide the market demand (quality and/or price) and make the development in a way of copy-paste. But how often these copy-paste formulations meet the market demands? Not very often.
What tools formulators have to meet both conflicting parties. How to meet the demands of the market and development.

Speakers

20 November

12:50 - 13:20

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/20/2019 12:50 11/20/2019 13:20 Digital assistant for formulation development
Currently, drug product development is based on empirical methods; the outcome often depends on the expertise and intuition of individual formulators. As a result, the development process can be time-intensive, costly, and has a high risk of failure. To lower the risk of failure and reduce the number of time-consuming and costly lab experiments, BASF has developed a science-based formulation prediction system that enables specialists to design robust drug formulations. Such system will be presented for the first time in Russia at Pharmtechprom forum.
Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session A – Raw materials and pharmaceutical ingredients

Digital assistant for formulation development

Currently, drug product development is based on empirical methods; the outcome often depends on the expertise and intuition of individual formulators. As a result, the development process can be time-intensive, costly, and has a high risk of failure. To lower the risk of failure and reduce the number of time-consuming and costly lab experiments, BASF has developed a science-based formulation prediction system that enables specialists to design robust drug formulations. Such system will be presented for the first time in Russia at Pharmtechprom forum.

Speakers

20 November

13:20 - 13:30

Discussion

20 November

13:30 - 14:00

Networking break

20 November

14:00 - 17:00

Session B – Technologies and equipment for pharmaceutical production. N. Pyatigorskaya, I.M. Sechenov First Moscow State Medical University, Head of Chair of Industrial Pharmacy, Pharm. D., Prof.

20 November

14:00 - 14:30

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/20/2019 14:00 11/20/2019 14:30 Isolators for Chemical and Pharmaceuticals application: Process Equipment integration into HPAPI’s containment system Today the request of handling toxic compound in safe way is becoming more and more actual. From Charging reactors and preparation vessels to final packaging/filling operations the attention to operator safety and product protection has to be taken in consideration by using the right technology. Using rigid Isolators in most of the case is the only available solution to achieve both operator safety by process containment and product protection. The presentation is giving right indication in order to be able to select the proper containment system in function of the real necessity. Some case studies are also presented to show the state of the art and latest innovation in this field. Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session B – Technologies and equipment for pharmaceutical production

Isolators for Chemical and Pharmaceuticals application: Process Equipment integration into HPAPI’s containment system

Today the request of handling toxic compound in safe way is becoming more and more actual. From Charging reactors and preparation vessels to final packaging/filling operations the attention to operator safety and product protection has to be taken in consideration by using the right technology. Using rigid Isolators in most of the case is the only available solution to achieve both operator safety by process containment and product protection. The presentation is giving right indication in order to be able to select the proper containment system in function of the real necessity. Some case studies are also presented to show the state of the art and latest innovation in this field.

Speakers

20 November

14:35 - 15:05

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/20/2019 14:35 11/20/2019 15:05 Gentle processing of ampoules and vials: One machine fits all Which general and upcoming trends are influencing sterile ampoule and vial filling and processing?
Which technical solutions are needed to meet these trends and to process liquid containers in an adequate and secure way?
Let´s have a deeper look on:
  • High speed processing
  • In-Line inspection
  • 100% In Process control
  • Flexibiltiy of filling systems
  • Minimizing of product loss
Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session B – Technologies and equipment for pharmaceutical production

Gentle processing of ampoules and vials: One machine fits all

Which general and upcoming trends are influencing sterile ampoule and vial filling and processing?
Which technical solutions are needed to meet these trends and to process liquid containers in an adequate and secure way?
Let´s have a deeper look on:

  • High speed processing
  • In-Line inspection
  • 100% In Process control
  • Flexibiltiy of filling systems
  • Minimizing of product loss

Speakers

20 November

15:10 - 15:40

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/20/2019 15:10 11/20/2019 15:40 Handling from Powder and Liquid in the Pharmacy Mueller Systems is a leading manufacturer of stainless-steel containers, stainless steel drums and handling equipment, offering innovative solutions and the highest quality standards. Alongside perfecting stainless-steel drums, hoppers, silos and special stainless-steel containers together with stationary and mobile handling equipment for technical processing applications in various industrial areas. MCS cleaning systems are characterized by a definable cleaning and drying process.
 
Müller handling equipment figures:
– Stable, lightweight and durable
– Capacity: from 0,1 L to 2000 L
- Diameter: from 80 mm to 1200 mm
– Lidded drums and drums with bungs, cylindrical and conical
– Polished surfaces for optimum product discharge
– GMP pharmaceutical standard
– Modular design
 
The presentation will give the different types of containers for storage and transportation of liquids and powders offered by Müller, their characteristics and advantages of use.
Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session B – Technologies and equipment for pharmaceutical production

Handling from Powder and Liquid in the Pharmacy

Mueller Systems is a leading manufacturer of stainless-steel containers, stainless steel drums and handling equipment, offering innovative solutions and the highest quality standards. Alongside perfecting stainless-steel drums, hoppers, silos and special stainless-steel containers together with stationary and mobile handling equipment for technical processing applications in various industrial areas. MCS cleaning systems are characterized by a definable cleaning and drying process.
 
Müller handling equipment figures:
– Stable, lightweight and durable
– Capacity: from 0,1 L to 2000 L
- Diameter: from 80 mm to 1200 mm
– Lidded drums and drums with bungs, cylindrical and conical
– Polished surfaces for optimum product discharge
– GMP pharmaceutical standard
– Modular design
 
The presentation will give the different types of containers for storage and transportation of liquids and powders offered by Müller, their characteristics and advantages of use.

Speakers

20 November

15:45 - 16:15

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/20/2019 15:45 11/20/2019 16:15 Suspension adaptation and process development of Multipotent Mesenchymal Stem Cells for cell therapy applications Human mesenchymal stem cells (hMSCs) have great potential as cellular therapeutics due to their ability to differentiate towards multiple lineages. Possible applications range from the treatment of Crohn’s disease to graft versus host disease and also target cardiovascular conditions among others.
To date, the generation of large numbers of hMSCs is typically achieved using two dimensional (2D) tissue culture vessels. However, this culturing approach requires a high level of operator manipulation and offers little in the way of culture control. A possible solution is the scale-up and large-scale production of hMSCs in three dimension (3D) culture on microcarriers utilizing stirred tank bioreactors. Here we demonstrate the utility of the ambr15 and ambr250 modular stirred tank bioreactor systems as valuable tools for hMSC process development and optimization paving the way for the large-scale production of clinically relevant numbers of hMSCs.
Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session B – Technologies and equipment for pharmaceutical production

Suspension adaptation and process development of Multipotent Mesenchymal Stem Cells for cell therapy applications

Human mesenchymal stem cells (hMSCs) have great potential as cellular therapeutics due to their ability to differentiate towards multiple lineages. Possible applications range from the treatment of Crohn’s disease to graft versus host disease and also target cardiovascular conditions among others.
To date, the generation of large numbers of hMSCs is typically achieved using two dimensional (2D) tissue culture vessels. However, this culturing approach requires a high level of operator manipulation and offers little in the way of culture control. A possible solution is the scale-up and large-scale production of hMSCs in three dimension (3D) culture on microcarriers utilizing stirred tank bioreactors. Here we demonstrate the utility of the ambr15 and ambr250 modular stirred tank bioreactor systems as valuable tools for hMSC process development and optimization paving the way for the large-scale production of clinically relevant numbers of hMSCs.

Speakers

20 November

16:20 - 16:50

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/20/2019 16:20 11/20/2019 16:50 High-throughput glycan screening of crude and purified samples Glycosylation is considered among the most important post-translational modifications when developing new biologics. Having a significant impact on product performance and variability, glycosylation is a critical quality attribute (CQA) influencing product safety and efficacy. Protein glycosylation can affect isolation and purification steps (process consistency), pharmacokinetics (half-life) properties and in vitro stability (product shelf-life). Sialic acid content is especially important as it can impact the stability and clearance of a protein.
ForteBio’s Sialic Acid (GlyS) Kit provides a rapid and convenient method for relative screening of terminal sialic acid content in crude or purified samples. Sialic acid data can be combined with titer data using Octet Data Analysis HT software version 11.1 or higher to funnel through samples that are high producers and have desirable sialic acid content.
Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session B – Technologies and equipment for pharmaceutical production

High-throughput glycan screening of crude and purified samples

Glycosylation is considered among the most important post-translational modifications when developing new biologics. Having a significant impact on product performance and variability, glycosylation is a critical quality attribute (CQA) influencing product safety and efficacy. Protein glycosylation can affect isolation and purification steps (process consistency), pharmacokinetics (half-life) properties and in vitro stability (product shelf-life). Sialic acid content is especially important as it can impact the stability and clearance of a protein.
ForteBio’s Sialic Acid (GlyS) Kit provides a rapid and convenient method for relative screening of terminal sialic acid content in crude or purified samples. Sialic acid data can be combined with titer data using Octet Data Analysis HT software version 11.1 or higher to funnel through samples that are high producers and have desirable sialic acid content.

Speakers

20 November

16:50 - 17:00

Discussion & closing remarks

Day 3

Seminars - November, 21

21 November

10:30 - 11:30

Prezentation Zone B, Hall 8, Pavillion 2


Add to calendar 11/21/2019 10:30 11/21/2019 11:30 Seminar by Alfa Lab: New criterias of protective clothing selection Prezentation Zone B, Hall 8, Pavillion 2 Europe/Moscow

Seminars

Seminar by Alfa Lab: New criterias of protective clothing selection

21 November

11:00 - 12:00

Presentation Zone A, Hall 7, Pavillion 2


Add to calendar 11/21/2019 11:00 11/21/2019 12:00 Seminar by Merck: BioContinuum. Merck Biopharm Continuous Processing Platform Presentation Zone A, Hall 7, Pavillion 2 Europe/Moscow

Seminars

Seminar by Merck: BioContinuum. Merck Biopharm Continuous Processing Platform

21 November

11:40 - 12:40

Prezentation Zone B, Hall 8, Pavillion 2


Add to calendar 11/21/2019 11:40 11/21/2019 12:40 Seminar by Alfa Lab: Advanced cleaning solutions with deconex® for the biotech production Prezentation Zone B, Hall 8, Pavillion 2 Europe/Moscow

Seminars

Seminar by Alfa Lab: Advanced cleaning solutions with deconex® for the biotech production

21 November

12:10 - 13:10

Presentation Zone A, Hall 7, Pavillion 2


Add to calendar 11/21/2019 12:10 11/21/2019 13:10 Seminar by HVD: Third generation QCM biosensors, miniaturized immunoassays & High-throughput screening for R&D and Analytics Presentation Zone A, Hall 7, Pavillion 2 Europe/Moscow

Seminars

Seminar by HVD: Third generation QCM biosensors, miniaturized immunoassays & High-throughput screening for R&D and Analytics

21 November

12:50 - 13:50

Prezentation Zone B, Hall 8, Pavillion 2


Add to calendar 11/21/2019 12:50 11/21/2019 13:50 Seminar by NPK "Relsib": Devices and systems of NPK "Relsib" for monitoring the conditions of storage and transportation of medicines Prezentation Zone B, Hall 8, Pavillion 2 Europe/Moscow

Seminars

Seminar by NPK "Relsib": Devices and systems of NPK "Relsib" for monitoring the conditions of storage and transportation of medicines

21 November

14:00 - 15:00

Prezentation Zone B, Hall 8, Pavillion 2


Add to calendar 11/21/2019 14:00 11/21/2019 15:00 Seminar by Fizlabpribor: Practical experience in introducing innovative domestic developments in the pharmaceutical production of biotechnological substances Prezentation Zone B, Hall 8, Pavillion 2 Europe/Moscow

Seminars

Seminar by Fizlabpribor: Practical experience in introducing innovative domestic developments in the pharmaceutical production of biotechnological substances

Pharmtechprom forum - November, 21

Date: November, 20-21 
Place: Conference Hall L, Hall 7, Pavillion 2
Participation: free, electronic ticket based
Language: Russian

21 November

10:00 - 13:30

Session C – Packaging equipment and materials. Moderator: Vladimir Stolypin, Erecton (Russia), Production Director, Ph.D.

21 November

10:00 - 10:25

Registration of participants

21 November

10:30 - 11:00

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/21/2019 10:30 11/21/2019 11:00 New trends in primary packaging. Child safety Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session C – Packaging equipment and materials

New trends in primary packaging. Child safety

Speakers

21 November

11:05 - 11:35

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/21/2019 11:05 11/21/2019 11:35 New solutions for a vital process: Implementing aseptic filling with Ready-to-Use molded glass vials
The introduction of Sterinity by SGD Pharma (Paris, France), a global leader of molded glass packaging, makes the manufacture of RTU molded glass vials commercially accessible for the first time. Powered by the well-established EZ Fill® platform from Ompi (Padua, Italy) this new product extends the commercial and practical benefits of RTU to a widest range of applications. 
The Sterinity offer provides an ‘off-the-shelf’ solution for aseptic filling, producing RTU molded glass vials suitably packaged for streamlined, final ‘fill and finish’ processing in a range of proprietary filling technology.  Sterinity is leveraging the advantages of Ompi EZ-fill® secondary packaging, that has been already tested and adopted in a wide range of fill-finish equipment platforms.  
Vials are produced and 100% inspected in a clean room environment at the SGD Pharma plant, then washed with WFI, depyrogenized, packed and sterilized by ethylene oxide. Packed and sealed, RTU glass vials can be stored, with 5 years shelf life, and/or transported, ready for use as required.
The Sterinity offer uses molded glass vials made from Type I glass of exemplary quality. A steadily expanding portfolio of products in a range of sizes will be commercialized over the next one to two years, focusing on two core designs: a premium quality ISO design and an optimized EasyLyo® product. Both types of vial are currently available for use in tray format; nest and tub configurations are currently in development.
Sterinity boasts a diverse glass vial portfolio that meets all industry standards and customer requirements. As the need for flexible filling increases, companies will be seeking a cost-effective quality solution to streamline production and increase the speed of changeover. As the first commercial solution for RTU molded glass, SGD Pharma’s Sterinity platform is a viable answer to this pressing issue. 
Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session C – Packaging equipment and materials

New solutions for a vital process: Implementing aseptic filling with Ready-to-Use molded glass vials

The introduction of Sterinity by SGD Pharma (Paris, France), a global leader of molded glass packaging, makes the manufacture of RTU molded glass vials commercially accessible for the first time. Powered by the well-established EZ Fill® platform from Ompi (Padua, Italy) this new product extends the commercial and practical benefits of RTU to a widest range of applications. 
The Sterinity offer provides an ‘off-the-shelf’ solution for aseptic filling, producing RTU molded glass vials suitably packaged for streamlined, final ‘fill and finish’ processing in a range of proprietary filling technology.  Sterinity is leveraging the advantages of Ompi EZ-fill® secondary packaging, that has been already tested and adopted in a wide range of fill-finish equipment platforms.  
Vials are produced and 100% inspected in a clean room environment at the SGD Pharma plant, then washed with WFI, depyrogenized, packed and sterilized by ethylene oxide. Packed and sealed, RTU glass vials can be stored, with 5 years shelf life, and/or transported, ready for use as required.
The Sterinity offer uses molded glass vials made from Type I glass of exemplary quality. A steadily expanding portfolio of products in a range of sizes will be commercialized over the next one to two years, focusing on two core designs: a premium quality ISO design and an optimized EasyLyo® product. Both types of vial are currently available for use in tray format; nest and tub configurations are currently in development.
Sterinity boasts a diverse glass vial portfolio that meets all industry standards and customer requirements. As the need for flexible filling increases, companies will be seeking a cost-effective quality solution to streamline production and increase the speed of changeover. As the first commercial solution for RTU molded glass, SGD Pharma’s Sterinity platform is a viable answer to this pressing issue. 

Speakers

21 November

11:40 - 12:10

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/21/2019 11:40 11/21/2019 12:10 Packing trends for Biologic Drugs Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session C – Packaging equipment and materials

Packing trends for Biologic Drugs

Speakers

21 November

12:15 - 12:45

Presentation Zone A, Hall 7, Pavillion 2


Add to calendar 11/21/2019 12:15 11/21/2019 12:45 Ready-to-use packaging solutions to transform injectable drug manufacturing Presentation Zone A, Hall 7, Pavillion 2 Europe/Moscow

Session C – Packaging equipment and materials

Ready-to-use packaging solutions to transform injectable drug manufacturing

Speakers

21 November

12:50 - 13:20

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/21/2019 12:50 11/21/2019 13:20 Sympfiny®, an award-winning innovative oral delivery system for distribution of multiparticulate drug formulations
Sympfiny® is an innovative oral delivery system for dosing and dispensing dry powder, microsphere and multiparticulate drug formulations.
This breakthrough system enables caregivers to store, extract and deliver dry drugs with the same familiar technique used for liquid oral drugs.
The patent pending design allows controlled and precise dosage and ensures all the medication is dispensed directly to the patient’s mouth. The compact, portable container was designed to be used in a wide variety of settings and by a diverse set of users.
Designed with the entire supply chain in mind, the system fits common bottle sizes and can be pre-filled or filled at a pharmacy. The internal valve and bottle cap protects the drug through storage and use. The re-usable syringe comes in two sizes and has selectable dose settings.
Further in this presentation you will hear detailed discussion about:
 
  1. Versatile Bulk Container
• On site fill capability
• Humidity resistant
• Easy to customize
• Compatible with child-proof caps
  1. Novel Interlocking Design
• Simple to use
• Prevents accidental drug spills
• Seals against contaminants
  1. Intuitive Dispensing Platform
• Dispenses similarly to liquid oral syringe
• One handed operation
• Reusable and easy to clean
  1. User Friendly Dose Settings
• Multiple dose settings in a single platform
• Customizable by pharmacist or caregiver to meet the needs of the patient population
 
Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session C – Packaging equipment and materials

Sympfiny®, an award-winning innovative oral delivery system for distribution of multiparticulate drug formulations

Sympfiny® is an innovative oral delivery system for dosing and dispensing dry powder, microsphere and multiparticulate drug formulations.
This breakthrough system enables caregivers to store, extract and deliver dry drugs with the same familiar technique used for liquid oral drugs.
The patent pending design allows controlled and precise dosage and ensures all the medication is dispensed directly to the patient’s mouth. The compact, portable container was designed to be used in a wide variety of settings and by a diverse set of users.
Designed with the entire supply chain in mind, the system fits common bottle sizes and can be pre-filled or filled at a pharmacy. The internal valve and bottle cap protects the drug through storage and use. The re-usable syringe comes in two sizes and has selectable dose settings.
Further in this presentation you will hear detailed discussion about:
 
  1. Versatile Bulk Container
• On site fill capability
• Humidity resistant
• Easy to customize
• Compatible with child-proof caps
  1. Novel Interlocking Design
• Simple to use
• Prevents accidental drug spills
• Seals against contaminants
  1. Intuitive Dispensing Platform
• Dispenses similarly to liquid oral syringe
• One handed operation
• Reusable and easy to clean
  1. User Friendly Dose Settings
• Multiple dose settings in a single platform
• Customizable by pharmacist or caregiver to meet the needs of the patient population
 

Speakers

21 November

13:20 - 13:30

Discussion

21 November

14:00 - 17:00

Session D – Auxiliary processes in pharmaceutical production. Moderator: Oleg Spitsky, Biopharmprogect (Russia), Quality System Manager, GMP Expert

21 November

14:00 - 14:30

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/21/2019 14:00 11/21/2019 14:30 Lifecycle Management of design and implementation of a new pharmaceutical production Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session D – Auxiliary processes in pharmaceutical production

Lifecycle Management of design and implementation of a new pharmaceutical production

Speakers

21 November

14:35 - 15:05

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/21/2019 14:35 11/21/2019 15:05 Global revision of EU GMP and ISO PPE. What will we consider for choosing cleanroom garments and gloves Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session D – Auxiliary processes in pharmaceutical production

Global revision of EU GMP and ISO PPE. What will we consider for choosing cleanroom garments and gloves

Speakers

21 November

15:10 - 15:40

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/21/2019 15:10 11/21/2019 15:40 Review of regulatory requirements for cold chain ambient conditions monitoring. Hardware and software solutions 1.            Comparison of applicable legal requirements for transportation and storage temperature of sensitive pharmaceuticals at each step of the cold chain
2.            Upcoming  changes in regulatory and market requirements for temperature monitoring
3.            Recent  changes in the methodological approaches
4.            Review of existing and perspective technical/software solutions for temperature monitoring
 
Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session D – Auxiliary processes in pharmaceutical production

Review of regulatory requirements for cold chain ambient conditions monitoring. Hardware and software solutions

1.            Comparison of applicable legal requirements for transportation and storage temperature of sensitive pharmaceuticals at each step of the cold chain
2.            Upcoming  changes in regulatory and market requirements for temperature monitoring
3.            Recent  changes in the methodological approaches
4.            Review of existing and perspective technical/software solutions for temperature monitoring
 

Speakers

21 November

15:45 - 16:15

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/21/2019 15:45 11/21/2019 16:15 21 CFR part 11 compliant automation of quality control to reduce costs in pharmaceutical A recent report by Pharmaceutical Online suggests that circa 79% of 483 warning letters issued by the FDA to the biopharmaceutical industry sited deficiencies in their data integrity.
Despite guidance from the FDA, cleanroom environmental monitoring  and quality control (water for injection) remains an intensely manual process, with many opportunities for human error to create gaps and errors in the data.
In their 21CFR part 11 guidance, the FDA have given recommendations on what good data integrity looks like and this presentation explains their advice in the context of current cleanroom environmental practices and quality control (water for injection) and shows how the FDA guidance can be applied to improve data integrity.
Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session D – Auxiliary processes in pharmaceutical production

21 CFR part 11 compliant automation of quality control to reduce costs in pharmaceutical

A recent report by Pharmaceutical Online suggests that circa 79% of 483 warning letters issued by the FDA to the biopharmaceutical industry sited deficiencies in their data integrity.
Despite guidance from the FDA, cleanroom environmental monitoring  and quality control (water for injection) remains an intensely manual process, with many opportunities for human error to create gaps and errors in the data.
In their 21CFR part 11 guidance, the FDA have given recommendations on what good data integrity looks like and this presentation explains their advice in the context of current cleanroom environmental practices and quality control (water for injection) and shows how the FDA guidance can be applied to improve data integrity.

Speakers

21 November

16:20 - 16:50

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/21/2019 16:20 11/21/2019 16:50 Solutions from Advanced Microdevices (MDI) for pharmaceutical industries. Single use systems for biotechnology. Customized systems Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session D – Auxiliary processes in pharmaceutical production

Solutions from Advanced Microdevices (MDI) for pharmaceutical industries. Single use systems for biotechnology. Customized systems

Speakers

21 November

16:50 - 17:00

Discussion & closing remarks