Event Programme
19 November - 22 November
Day 1
Pharmtech & Ingredients Official Opening Ceremony
19 November
10:30 - 11:00
Presentation Zone A, Hall 7, Pavillion 2
Ceremony
Official Opening Ceremony
Round table discussion: Total readiness for medicine labelling
Participation: free, electronic ticket based
Language: Russian
Co-organiser: Association of Russian Pharmaceutical Manufacturers (ARFP)
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.
19 November
12:00 - 14:00
Presentation Zone A, Hall 7, Pavillion 2
Presentation Zone A, Hall 7, Pavillion 2 Europe/Moscow
Round table
Total readiness for medicine labelling
More speakers details>>
Moderators
Elena Kudryavceva
Herman Inozemtsev
Victor Dmitriyev
Speakers
Anatoliy Tentser
Dmitry Alkhazov
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Evgenii Nifantev
Margarita Mustafina
Mikhail Ignatov
Vadim Kukava
Vladimir Shipkov
Round table discussion: Export potential: new growth points
Participation: free, electronic ticket based
Language: Russian
Co-organiser: GMP News
Questions for discustion:
1. State measures of support and targets for exporting pharmaceutical products
2. Prospects for developing the Eurasian Economic Union’s pharmaceutical market. Integrating the union into the international trade system
3. Measures for supporting exports as part of the International Cooperation and Export national project
4. Promising export markets and mechanisms to overcome regulatory barriers
5. Operational schemes and creating entry points to international markets: case studies from Russian and international companies
19 November
15:00 - 17:00
Presentation Zone A, Hall 7, Pavillion 2
Round table
Export potential: new growth points
More speaker details>>
Moderators
Irina Novikova
Speakers
Alexey Teteruk
Andrey Chicherin
Dmitry Chagin
Ilya Vesker
Ivan Glushkov
Kirill Zaitsev
Vitaliy Miller
Wil Mustafin
Seminars - November, 19
19 November
11:00 - 13:00
Prezentation Zone B, Hall 8, Pavillion 2
Seminars
Seminar by Gluvex: Discussion area: Engineering problems. Yesterday, today, tomorrow
19 November
13:10 - 14:10
Prezentation Zone B, Hall 8, Pavillion 2
Seminars
Seminar by Lonza: Innovative solutions from Lonza for healthcare industry
19 November
14:20 - 15:20
Prezentation Zone B, Hall 8, Pavillion 2
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
Participation: free, electronic ticket based
Language: Russian
Co-organiser: 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
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
Discussion session
The processes combination in the SDF production as the basis for highly efficient production
Speakers
Dmitry Polstyanov
20 November
11:00 - 13:30
Presentation Zone A, Hall 7, Pavillion 2
Discussion session
Digital Reality is Already Here. Industry 4.0. How do smart machines influence efficiency of production?
More speaker details>>
Speakers
Angelica Kosinova
Federico Finotti
20 November
11:00 - 13:30
Presentation Zone A, Hall 7, Pavillion 2
Discussion session
Effectiveness of Clean utilities and Solution preparation systems at each stage of life cycle
Speakers
Sergey Movsesov
20 November
11:00 - 13:30
Presentation Zone A, Hall 7, Pavillion 2
Discussion session
10 life hacks to increase efficiency at the pharmaceutical production construction phase
Speakers
Grigoriy Peglivanyan
20 November
11:00 - 13:30
Presentation Zone A, Hall 7, Pavillion 2
Discussion session
PAT tools can actually improve effectiveness in OSD production
More speaker details>>
Speakers
Carlo Tenore
Dmitry Koryagin
20 November
11:00 - 13:30
Presentation Zone A, Hall 7, Pavillion 2
Discussion session
Boosting productivity with Uhlmann Tool Management
Speakers
David Haug
20 November
11:00 - 13:30
Presentation Zone A, Hall 7, Pavillion 2
Discussion session
Methods of production efficiency improvement
Speakers
Andrey Stukan
Round table discussion: API production: the economic aspect
Participation: free, electronic ticket based
Language: Russian
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.
20 November
14:30 - 16:30
Presentation Zone A, Hall 7, Pavillion 2
Round table
API production: the economic aspect
More speaker details>>
Moderators
Ivan Glushkov
Speakers
Alexander Semenov
Alexey Alekhin*
Georgy Khachiyan
Konstantin Perov
Ludmila Scherbakova
Ratmir Dashkin
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Yuri Sanakoev
Zakhar Golant
Seminars - November, 20
20 November
11:00 - 12:00
Prezentation Zone B, Hall 8, Pavillion 2
Seminars
Seminar by Asahi Kasei Bioprocess Europe: PLANOVA Virus Removal Filters
20 November
12:10 - 14:10
Prezentation Zone B, Hall 8, Pavillion 2
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
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
Place: Conference Hall L, Hall 7, Pavillion 2
Participation: free, electronic ticket based
Language: Russian
Download the forum programme>>
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
- Impurities formation in drug formulation
- Excipient instability and review of some decomposition products
- Impurities influence on API stability
- Advantages of drug formulation development driven by Super Refined excipients
Session A – Raw materials and pharmaceutical ingredients
Liquid and soft drugs formulation development with Super Refined excipients, eliminating instability and impurities issues
- Impurities formation in drug formulation
- Excipient instability and review of some decomposition products
- Impurities influence on API stability
- Advantages of drug formulation development driven by Super Refined excipients
Speakers
Olesya Vereschagina
20 November
11:05 - 11:35
Conference Hall L, Hall 7, Pavillion 2
• 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
Alexandra Voskoboynikova
20 November
11:40 - 12:10
Conference Hall L, Hall 7, Pavillion 2
Mucoadhesive dosage forms can be designed to provide long-term retention at contact point, providing a controlled release of APIs to improve the therapeutic result. Among the most effective excipients with stable mucoadhesive properties are the Carbopol™ carbomers manufactured by Lubrizol. These substances are high molecular weight polymers of acrylic acid chemically cross-linked with polyalkenyl alcohols or divinyl glycol.
Conference Hall L, Hall 7, Pavillion 2 Europe/MoscowSession A – Raw materials and pharmaceutical ingredients
Development of mucoadhesive drug delivery systems with Carbopols
Mucoadhesive dosage forms can be designed to provide long-term retention at contact point, providing a controlled release of APIs to improve the therapeutic result. Among the most effective excipients with stable mucoadhesive properties are the Carbopol™ carbomers manufactured by Lubrizol. These substances are high molecular weight polymers of acrylic acid chemically cross-linked with polyalkenyl alcohols or divinyl glycol.
Speakers
Engin Sari
20 November
12:15 - 12:45
Conference Hall L, Hall 7, Pavillion 2
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
Renat Kashapov
20 November
12:50 - 13:20
Conference Hall L, Hall 7, Pavillion 2
Session A – Raw materials and pharmaceutical ingredients
Digital assistant for formulation development
Speakers
Nadezhda Romanova
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
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
Stefano Butti
20 November
14:35 - 15:05
Conference Hall L, Hall 7, Pavillion 2
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
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
Tobias Göttler
20 November
15:10 - 15:40
Conference Hall L, Hall 7, Pavillion 2
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
Jakob Jenner
20 November
15:45 - 16:15
Conference Hall L, Hall 7, Pavillion 2
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
Quentin Vicard
20 November
16:20 - 16:50
Conference Hall L, Hall 7, Pavillion 2
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
Sergey Irkhin
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
Seminars
Seminar by Alfa Lab: New criterias of protective clothing selection
21 November
11:00 - 12:00
Presentation Zone A, Hall 7, Pavillion 2
Seminars
Seminar by Merck: BioContinuum. Merck Biopharm Continuous Processing Platform
21 November
11:40 - 12:40
Prezentation Zone B, Hall 8, Pavillion 2
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
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
Seminars
Seminar by NPK "Relsib": Devices and systems of NPK "Relsib" for monitoring the conditions of storage and transportation of medicines
21 November
13:20 - 14:20
Presentation Zone A, Hall 7, Pavillion 2
Seminars
Seminar by Antares Vision: Product inspection & traceability: how interconnection will speed up a new digital standard
21 November
14:00 - 15:00
Prezentation Zone B, Hall 8, Pavillion 2
Seminars
Seminar by Fizlabpribor: Practical experience in introducing innovative domestic developments in the pharmaceutical production of biotechnological substances
21 November
15:10 - 16:10
Prezentation Zone B, Hall 8, Pavillion 2
Seminars
Track & Trace. Future of supply chain management: book presentation by Ravil Gimadiev, Original Group, CEO
21 November
16:20 - 17:20
Prezentation Zone B, Hall 8, Pavillion 2
Seminars
Seminar by Boccard: Plasma Fractionation: best practices for successful technology transfers
Pharmtechprom forum - November, 21
Place: Conference Hall L, Hall 7, Pavillion 2
Participation: free, electronic ticket based
Language: Russian
Download the forum programme>>
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
2. Regulations and mandatory requirements on Child Safety packaging-Russia, EU, USA and China;
3. Developing status and trends on Child Safety packaging-Russia, EU, USA and China. Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow
Session C – Packaging equipment and materials
New trends in primary packaging. Child safety
1. Facts - Medicine mis-taken by children under 5 year old;
2. Regulations and mandatory requirements on Child Safety packaging-Russia, EU, USA and China;
3. Developing status and trends on Child Safety packaging-Russia, EU, USA and China.
Speakers
Janny Hsing
21 November
11:05 - 11:35
Conference Hall L, Hall 7, Pavillion 2
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.
Session C – Packaging equipment and materials
New solutions for a vital process: Implementing aseptic filling with Ready-to-Use molded glass vials
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
Rasa Krivickiene
21 November
11:40 - 12:10
Conference Hall L, Hall 7, Pavillion 2
Which are options we can offer to the market? Polymer prefilled syringes are one option, but existing systems made of glass have been improved to fulfill the needs too. Nested vials are a new offering on the market. Potential risk asks for a minimized particle level, reduced or completely eliminated siliconization, metal free forming to avoid tungsten residuals, strengthen glass accepting pH attacks and mechanical impact, an extreme low extractable and leachable profile and very precise tolerances to work best with drug and device are addressed in this presentation.
We will show existing and future solutions for an demanding market on primary packaging solutions. Discussing about technical and logistic options to serve the needs of today and tomorrow’s medication. The best packaging material options for your individual product will be demonstrated.
Session C – Packaging equipment and materials
Packing trends for Biologic Drugs
Which are options we can offer to the market? Polymer prefilled syringes are one option, but existing systems made of glass have been improved to fulfill the needs too. Nested vials are a new offering on the market. Potential risk asks for a minimized particle level, reduced or completely eliminated siliconization, metal free forming to avoid tungsten residuals, strengthen glass accepting pH attacks and mechanical impact, an extreme low extractable and leachable profile and very precise tolerances to work best with drug and device are addressed in this presentation.
We will show existing and future solutions for an demanding market on primary packaging solutions. Discussing about technical and logistic options to serve the needs of today and tomorrow’s medication. The best packaging material options for your individual product will be demonstrated.
Speakers
Dr. Wenzel Novak
21 November
12:15 - 12:45
Presentation Zone A, Hall 7, Pavillion 2
1) Global RTU-standard with SCHOTT.
2) Key benefits of standardization of the iQ™-Platform.
3) 3 products – all in one tub.
4) Accelerate drug development and market launch.
5) Flexibility in injection drug manufacturing with iQ™ Platform.
6) Perfect Fit components for iQ™ Platform.
7) Flexible fillings concept – tendency to increase.
8) Clean manufacturing process – No issues with glass breakage and particles with RTU containers.
9) Enhance patience safety with iQ™ Platform.
Presentation Zone A, Hall 7, Pavillion 2 Europe/MoscowSession C – Packaging equipment and materials
Ready-to-use packaging solutions to transform injectable drug manufacturing
1) Global RTU-standard with SCHOTT.
2) Key benefits of standardization of the iQ™-Platform.
3) 3 products – all in one tub.
4) Accelerate drug development and market launch.
5) Flexibility in injection drug manufacturing with iQ™ Platform.
6) Perfect Fit components for iQ™ Platform.
7) Flexible fillings concept – tendency to increase.
8) Clean manufacturing process – No issues with glass breakage and particles with RTU containers.
9) Enhance patience safety with iQ™ Platform.
Speakers
Larissa Ostroukh
21 November
12:50 - 13:20
Conference Hall L, Hall 7, Pavillion 2
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:
- Versatile Bulk Container
• Humidity resistant
• Easy to customize
• Compatible with child-proof caps
- Novel Interlocking Design
• Prevents accidental drug spills
• Seals against contaminants
- Intuitive Dispensing Platform
• One handed operation
• Reusable and easy to clean
- User Friendly Dose Settings
• 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
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:
- Versatile Bulk Container
• Humidity resistant
• Easy to customize
• Compatible with child-proof caps
- Novel Interlocking Design
• Prevents accidental drug spills
• Seals against contaminants
- Intuitive Dispensing Platform
• One handed operation
• Reusable and easy to clean
- User Friendly Dose Settings
• Customizable by pharmacist or caregiver to meet the needs of the patient population
Speakers
Tamas Öri
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
In the «Project Management for the Pharmaceutical Industry» guide, ISPE gives recommendations on how to implement such projects throughout their entire life cycle. During the project life cycle, there are three phases that are divided into six stages:
- Project initiation - 2. Planning - 3. Project Delivery
Feasibility - Conceptual - Project Delivery - Design - Implementation - Close-out
Session D – Auxiliary processes in pharmaceutical production
Lifecycle Management of design and implementation of a new pharmaceutical production
In the «Project Management for the Pharmaceutical Industry» guide, ISPE gives recommendations on how to implement such projects throughout their entire life cycle. During the project life cycle, there are three phases that are divided into six stages:
- Project initiation - 2. Planning - 3. Project Delivery
Feasibility - Conceptual - Project Delivery - Design - Implementation - Close-out
Speakers
Zdenek Pavelek
21 November
14:35 - 15:05
Conference Hall L, Hall 7, Pavillion 2
The global trend of transition from reusable garment to disposable ones: its advantages and great necessity. The most common misconception in the process of choosing cleanrooms garments. The parameters are usually not taken into account when comparing costs of cycles of disposable and reusable garments. The way the European GMP project specifies requirements for garment (detailed cases).
Changes in the European legislation concerning personal protective equipment and GOST, planned to have been adopted in the Russian Federation in 2020 (ISO 374-2016). Process of sorting out a new labeling of personal protective equipment.
As a bonus you’ll get a guide "How to choose very fast and - what is more important – accurate an optimal hands chemicals protection for your production with a help of a unique tool - Chemical Guardian"
Conference Hall L, Hall 7, Pavillion 2 Europe/MoscowSession D – Auxiliary processes in pharmaceutical production
Global revision of EU GMP and ISO PPE. What will we consider when choosing cleanroom garments and gloves
The global trend of transition from reusable garment to disposable ones: its advantages and great necessity. The most common misconception in the process of choosing cleanrooms garments. The parameters are usually not taken into account when comparing costs of cycles of disposable and reusable garments. The way the European GMP project specifies requirements for garment (detailed cases).
Changes in the European legislation concerning personal protective equipment and GOST, planned to have been adopted in the Russian Federation in 2020 (ISO 374-2016). Process of sorting out a new labeling of personal protective equipment.
As a bonus you’ll get a guide "How to choose very fast and - what is more important – accurate an optimal hands chemicals protection for your production with a help of a unique tool - Chemical Guardian"
Speakers
Vyacheslav Ryadinsky
21 November
15:10 - 15:40
Conference Hall L, Hall 7, Pavillion 2
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
Bulat Salikhyanov
21 November
15:45 - 16:15
Conference Hall L, Hall 7, Pavillion 2
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
Ekaterina Shakh
21 November
16:20 - 16:50
Conference Hall L, Hall 7, Pavillion 2
Production based on single use materials allows both large scale manufacturing of high-tech products in a short time and full compliance with quality standards. Unlike traditional solutions, single use technologies help to achieve significant savings of resources and time. As a result, companies, which use these technologies, highly improve their financial performance.
Founded in 1976, Advanced Microdevices (MDI) started its business with one single product. Nowadays MDI produces more than 2 million items, including products for laboratory and industrial scale membrane filtration, components for diagnostic tests and consumables for biotechnology. MDI exports its products to more than 50 countries all around the world.
The company produces a wide range of sterile disposable systems for various critical biopharmaceuticals and pharmaceuticals protocols. This includes simple systems for storage, transportation, preparation of solution, thawing and freezing, aseptic transmission; bags with straps and holders for bioreactors, intermediate storage and transportation; complex multicomponent assemblies with built-in filters for unique projects.
Session D – Auxiliary processes in pharmaceutical production
Solutions from Advanced Microdevices (MDI) for pharmaceutical industries. Single use systems for biotechnology. Customized systems
Production based on single use materials allows both large scale manufacturing of high-tech products in a short time and full compliance with quality standards. Unlike traditional solutions, single use technologies help to achieve significant savings of resources and time. As a result, companies, which use these technologies, highly improve their financial performance.
Founded in 1976, Advanced Microdevices (MDI) started its business with one single product. Nowadays MDI produces more than 2 million items, including products for laboratory and industrial scale membrane filtration, components for diagnostic tests and consumables for biotechnology. MDI exports its products to more than 50 countries all around the world.
The company produces a wide range of sterile disposable systems for various critical biopharmaceuticals and pharmaceuticals protocols. This includes simple systems for storage, transportation, preparation of solution, thawing and freezing, aseptic transmission; bags with straps and holders for bioreactors, intermediate storage and transportation; complex multicomponent assemblies with built-in filters for unique projects.
Speakers
Andrey Zavarzin
21 November
16:50 - 17:00
Discussion & closing remarks
Day 4
Project results
22 November
11:00 - 12:00
Presentation Zone A, Hall 7, Pavillion 2
Project results
Pharmtech Tutor 2019: results
Support and Sponsors
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