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Informa
07:30 - 08:20 50 mins
Registration
08:20 - 08:30 10 mins
Chairperson's Opening Remarks
  • Thomas R. Kreil - Senior Director, Global Pathogen Safety, Takeda
08:30 - 10:00 90 mins
Info
Viral Safety Considerations and Applications for ATMP’s
Ask the Regulators – Regulatory Breakfast Briefing
  • Albert Stühler - Deputy Head of Section, Paul-Ehrlich-Institut
  • Arifa Khan - Supervisory Microbiologist, FDA
  • Laurent Mallet - Senior Director, Product Conception and Development, Sanofi-Pasteur

In this hour-long session, delegates will be given the opportunity to pre-submit questions which will then be posed to the regulators and key leaders in the industry. Topics covered historically include:


  • ATMPs
  • Viral safety of raw materials
  • NGS
  • Viral clearance: Removal/Inactivation chromatography, filtration, viral reduction factor and heat
  • In vitro adventitious agent testing
10:00 - 10:30 30 mins
Info
Viral Safety Considerations and Applications for ATMP’s
A Holistic Approach to Upstream Viral Safety
  • Trish Greenhalgh - Marketing Manager - Biosafety Products, MilliporeSigma, Merck

All biologics production processes focus on preventing adventitious microorganisms from entering upstream processes. There are numerous technologies to minimize contamination risks but they are not all suitable for every processes. We will discuss the strengths and limitations of these technologies and explain how they can be integrated with advances in testing into a holistic upstream biosafety strategy.

10:30 - 11:30 60 mins
Morning Coffee and Networking
11:30 - 12:00 30 mins
Info
Ensuring Viral Safety during Process Intensification
Continuous virus inactivation process using a novel packed-bed reactor
  • Duarte Martins - PhD Student, Lab of Protein Technology and Downstream Processing, Dept of Biotechnology, University of Natural Resources and Life Sciences
  • Sebastian Lülf - Scientific Manager, Pathogen Saftey, Biotest AG

Talk 1:  Continuous virus inactivation process using a novel packed-bed reactor

Duarte Martins, PhD Student, Lab of Protein Technology and Downstream Processing, Dept of Biotechnology, University of Natural Resources and Life Sciences, Vienna


Talk Two: Virus inactivation by laboratory and by manufacturing scale UV-C irradiation in products of Human Plasma

 UV-C irradiation is widely used for virus and pathogen inactivation of air, surfaces and liquids of low optical density (OD), e.g. WFI water. UV-C irradiation of protein solutions is less common due to the very restricted penetration depth of UV-C irradiation which poses severe technical challenges (mostly: homogeneity of irradiation).

An advanced UV-C irradiation technology (UVivatec (R)) is presented, which is used for plasma products in/close to clinical trials. Data are shown and discussed for virus inactivation by laboratory and by manufacturing scale UV-C irradiation.

Sebastian Lülf, Scientific Manager, Pathogen Saftey, Biotest AG, Germany


12:00 - 12:30 30 mins
Ensuring Viral Safety during Process Intensification
Virus inactivation by laboratory and by manufacturing scale UV-C irradiation in products of Human Plasma
  • Sebastian Lülf - Scientific Manager, Pathogen Saftey, Biotest AG
12:30 - 13:00 30 mins
Info
Ensuring Viral Safety during Process Intensification
An Integrated Approach to Viral Clearance in Continuous Bioprocessing
  • Nigel Jackson - Principal Engineer R&D, Pall Biotech

Continuous bioprocesses have been proposed as a way of maximising bioprocess efficiency, flexibility and consistency. The potential for higher productivity while at the same time reducing cycle times, buffer usage, resin usage and required footprint are all attractive. However, the innovative approaches required to achieve this can significantly shift the operating design space for the unit operations which deliver process viral clearance. Validation of viral clearance could therefore easily be perceived as more complex, time consuming and expensive.

By applying a consistent approach of prior knowledge assessment, risk assessment and batch simulations of continuous processing, we are able to generate an integrated approach to viral clearance in chromatography, virus inactivation and virus filtration unit operations. We present the approaches and up-to-date results from all these process steps and our current progress on delivering robust and simple methods for continuous viral clearance.

13:00 - 13:45 45 mins
Lunch in the Exhibition Hall and Live Labs
13:45 - 14:15 30 mins
Info
Viral Reduction – Inactivation and Removal Considerations
Model viruses for viral clearance: Evaluation of the process capacity regarding different types of viruses
  • Philipp Petermann - Head of Viral Clearance Group & Test Facility Manager (GLP), Biologics Testing Solutions, Charles River

Viral clearance studies are performed to demonstrate the potential of the production process to efficiently inactivate and/or remove viruses which potentially contaminate the starting material. In case that the specific initiator viruses cannot be used representative model viruses are the first choice. In this presentation the proof of authority for different model viruses is demonstrated by examples of different process steps.

14:15 - 14:45 30 mins
Viral Reduction – Inactivation and Removal Considerations
Environmental restrictions and use of alternatives to Triton X-100 in virus inactivation
  • Johanna Kindermann - Manager, Pathogen Safety, Takeda
  • Jean-Baptiste Farcet - Senior Development Scientist, Process Development, Takeda
14:45 - 15:15 30 mins
Info
Viral Reduction – Inactivation and Removal Considerations
Effective inactivation of a wide range of viruses by pasteurisation
  • Wolfram Schäfer - Senior Manager, Virus Safety Development, CSL Behring

Pasteurization at 60°C for 10 hours has been implemented in the manufacturing process of therapeutic plasma proteins such as human albumin, coagulation factors, immunoglobulins, and enzyme inhibitors to inactivate blood-borne viruses of concern. A comprehensive compilation of the virus reduction capacity of pasteurization will be presented including the effect of stabilizers used to protect the therapeutic protein from modifications during heat treatment. Virus spiking studies were carried out under the routine manufacturing target variables, such as temperature and product-specific stabilizer composition. Additional studies were also performed under robustness conditions i.e. outside production specifications. Evidence will be provided that pasteurization is a very robust and reliable virus inactivation method with a broad effectiveness against enveloped and non-enveloped viruses encompassing known blood-borne pathogens and emerging or potentially emerging viruses.

15:15 - 15:45 30 mins
Viral Reduction – Inactivation and Removal Considerations
New Solutions for fully Single-Use Virus Filtration in Manufacturing
  • Anika Manzke - Product Manager Virus Clearance, Purification Technologies Division, Sartorius Stedim Biotech, Germany
16:15 - 16:45 30 mins
Afternoon Coffee
16:45 - 17:15 30 mins
Viral Reduction – Inactivation and Removal Considerations
Roche Diagnostics GmbH Case Study
  • Marc Bieberbach - Senior Research Associate, Roche Diagnostics GmbH
17:15 - 17:45 30 mins
Viral Reduction – Inactivation and Removal Considerations
Feedback from the BPOG Raw Material Variability Workstream
  • Aaron Mack - Engineer III, Biogen
17:45 - 17:50 5 mins
Plenary Changeover
17:50 - 18:20 30 mins
Info
Enhanced biocompatibility, integrity and assurance of quality supply of single use solutions in vaccine manufacturing
  • Jean-Marc Cappia - Group Vice President Marketing & Product Management, Sartorius Stedim Biotech

Key objectives:

The presentation provides an overview of the challenges associated with the increasing adoption of single-use systems (SUS) in vaccines manufacturing and outlines a supply chain and quality strategy where raw material specifications and end to end process controls achieve more consistent biocompatibility, integrity and assurance of quality supply of single use solutions in vaccine manufacturing.

Bas du formulaire


Abstract

Vaccines manufacturing processes are diverse and complex and require strong commitment to quality for every raw materials and process equipment. With single becoming mainstream technology in commercial manufacture of modern vaccines, there is an increasing reliance on supplier quality and growing regulatory and industry requirement for more transparency on supplier’s quality system and supply chain. Single use suppliers are expected to better characterize their materials and processes, control the variability, understand the impact on vaccine quality and continuously improve their quality systems.

The presentation introduces an integrated supply chain and quality by design strategy whereby SUS integrators partner with polymer and film suppliers to combine material science, film extrusion and bag making expertise. These collaborations help optimize the resins and films and provide better knowledge, specifications and controls of the entire manufacturing process. This in turns allows an in depth characterization and control of extractable substances and particles profiles.

The presentation outlines how establishing resin specifications, film extrusion design spaces and quality agreements can significantly reduce raw material variability, provide consistent biocompatibility and improve product robustness and integrity. End to end process control also enhances assurance of supply and change control.



Audience take-home messages:

  • Resin specification and film design space reduce material variability and improve product quality
  • Control of raw materials and processes enhances single use product biocompatibility & integrity
  • End to end process control also improves assurance of supply and change control for single use products
18:20 - 20:20 120 mins
Networking Drinks and Evening Social Event
07:30 - 08:20

Registration

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08:20 - 08:30

Chairperson's Opening Remarks

  • Thomas R. Kreil - Senior Director, Global Pathogen Safety, Takeda
More
Showing of Streams
10:30 - 11:30

Morning Coffee and Networking

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Showing of Streams
13:00 - 13:45

Lunch in the Exhibition Hall and Live Labs

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Showing of Streams
16:15 - 16:45

Afternoon Coffee

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Showing of Streams
17:45 - 17:50
Plenary Changeover

Plenary Changeover

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17:50 - 18:20
Info

Enhanced biocompatibility, integrity and assurance of quality supply of single use solutions in vaccine manufacturing

Key objectives:

The presentation provides an overview of the challenges associated with the increasing adoption of single-use systems (SUS) in vaccines manufacturing and outlines a supply chain and quality strategy where raw material specifications and end to end process controls achieve more consistent biocompatibility, integrity and assurance of quality supply of single use solutions in vaccine manufacturing.

Bas du formulaire


Abstract

Vaccines manufacturing processes are diverse and complex and require strong commitment to quality for every raw materials and process equipment. With single becoming mainstream technology in commercial manufacture of modern vaccines, there is an increasing reliance on supplier quality and growing regulatory and industry requirement for more transparency on supplier’s quality system and supply chain. Single use suppliers are expected to better characterize their materials and processes, control the variability, understand the impact on vaccine quality and continuously improve their quality systems.

The presentation introduces an integrated supply chain and quality by design strategy whereby SUS integrators partner with polymer and film suppliers to combine material science, film extrusion and bag making expertise. These collaborations help optimize the resins and films and provide better knowledge, specifications and controls of the entire manufacturing process. This in turns allows an in depth characterization and control of extractable substances and particles profiles.

The presentation outlines how establishing resin specifications, film extrusion design spaces and quality agreements can significantly reduce raw material variability, provide consistent biocompatibility and improve product robustness and integrity. End to end process control also enhances assurance of supply and change control.



Audience take-home messages:

  • Resin specification and film design space reduce material variability and improve product quality
  • Control of raw materials and processes enhances single use product biocompatibility & integrity
  • End to end process control also improves assurance of supply and change control for single use products
  • Jean-Marc Cappia - Group Vice President Marketing & Product Management, Sartorius Stedim Biotech
More
18:20 - 20:20

Networking Drinks and Evening Social Event

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