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07:30 - 08:50 80 mins
Registration and Morning Coffee
08:50 - 09:00 10 mins
Chairperson's Opening Remarks
  • Thomas R. Kreil - Senior Director, Global Pathogen Safety, Shire, Austria
09:00 - 09:30 30 mins
Important Aspects for Virus Safety of Advanced Therapy Medicinal Products (ATMPs) – a regulatory perspective
  • Albert Stühler - Deputy Head, Virus Safety, Paul-Ehrlich-Institut
09:30 - 10:00 30 mins
NGS – Progress and Updates
  • Laurent Mallet - ‎Associate VP, Head of Analytical R&D Europe, Sanofi Pasteur, France
  • Sensitivity
  • Use of NGS in the characterisation of cell substrates
  • Interest group updates
10:00 - 10:30 30 mins
Continuous In-Line Virus Inactivation For Next Generation Bioprocessing
  • Sarah Le Merdy - EU Technology Manager Viral Safety, Merck

The shift in industry toward connected and continuous monoclonal antibody (mAb) processing has necessitated the development of novel approaches to improve or replace traditional unit operations that rely on hold tanks or operate in bind-elute mode.  One such operation is virus inactivation with low pH, a critical virus reduction step in mAb downstream processing.  Traditional low pH inactivation operations involve one or more large holding tanks in which product is maintained at a target low pH level for a specific period of time, typically 30-60 minutes.  Translating this batch operation to a flow-through continuous process requires careful control of multiple factors to assure effective virus inactivation.

In this presentation, we describe the impact of buffer/mAb composition on the kinetics of virus inactivation.  We address incubation chamber design which has implications for system size, processing times, and safety factor.  Data demonstrating equivalency between batch and in-line systems is also presented.  In-line technology that replaces batch operations and enables effective virus inactivation is expected to play an important role in the development of next generation mAb processing operations.

10:30 - 11:15 45 mins
Morning Coffee and Networking
11:15 - 11:45 30 mins
Update on NGS for adventitious virus detection in biologics
  • Arifa Khan - Senior Investigator, FDA/CBER (awaiting final confirmation)
11:45 - 12:15 30 mins
Successes and challenges in NGS analysis of crude virus seed material
  • Mark Van Ooij - Principal Scientist, Janssen, The Netherlands
12:15 - 12:45 30 mins
Application of Prior Knowledge Assessment to Facilitate End User Virus Filter Validation
  • Nigel Jackson - Principal Engineer R&D, PALL Life Sciences

Application of Quality by Design (QbD) aids the systematic development of robust biopharmaceutical processes that adhere to regulatory expectation and requirements. The virus clearance process is a direct contributor to the assurance of patient safety and virus removal filtration is a robust and essential component within this process. With increasing knowledge of both virus filtration, and quality & risk management, use of QbD can inform and increase confidence in virus validation.

We present core validation data from Pall’s Pegasus™ virus filter portfolio to show process inputs that should be evaluated to determine critical control parameters, and ultimately, define the filter design space. This includes the impact of the process fluid properties, such as pH and ionic strength, as well as the process parameters, such as operating pressure and process interruptions. Deep understanding of the boundaries of the critical process parameters allows selection of appropriate control points enabling consistent viral clearance capability and production of a safe and high quality product. Such supplier data packages, used as part of the prior knowledge assessment, allow users to have confidence in their validation trials. We verify our virus filter design space by comparing it to collected end user virus validation data across ranges of fluid properties and process parameters.

12:45 - 14:00 75 mins
Lunch in the Exhibition Hall and Live Labs
14:00 - 14:30 30 mins
The use of detergents in viral inactivation – Case study on a patented ECO alternative
  • Edward Koepf - Process Development Scientist, Process Biochemistry, Biogen Idec, USA
14:30 - 15:00 30 mins
Triton X-100 – A strategic approach for continued use in virus inactivation
  • Johanna Kindermann - Manager, Shire, Austria
  • Triton X-100 is used as particularly effective virus inactivation reagent during the majority of biologics and plasma products manufacturing processes
    • Recently, it has been included on the banned substance list under EU REACH regulations, due to hormone-like effects of degradation products in the environment
    • Continued use for virus inactivation requires REACH authorization
  • Aspects to be considered for REACH authorization
    • Analysis of alternatives
    • Socio-economic analysis
    • Chemical safety report (exposure)
  • How to develop a strategy for authorization of continued TX-100 use as robust virus inactivating agent ?
15:00 - 15:30 30 mins
Continuous processing - The challenges and opportunities of virus retentive filtration
  • Anika Manzke - Product Manager Virus Clearance, Purification Technologies Division, Sartorius Stedim Biotech, Germany

The current discussion about continuous processing in upstream and downstream manufacturing for biopharmaceutical products leads to potential new challenges for all unit operations involved such as virus retentive filtration. The main focus of this presentation will be a Design of Experiment (DOE) study performed with a commercially available virus retentive filter to proof the robust virus retention in a fully continuous downstream process. The impact of relevant process parameters such as flow rate/ operating pressure and processing time on the retention performance was determined.

15:30 - 16:00 30 mins
Afternoon Coffee Break
16:00 - 16:30 30 mins
Cost Effective Prefiltration strategies for High Throughput Virus Filtration
  • Abhijit Shirke, Ph.D. - Scientist, Downstream Operations, CMC Biologics, Teva Pharmaceuticals

Virus filtration is a dedicated step for removal of both endogenous and adventitious virus in most mAb downstream processes. High throughput is essential to keep the cost of virus filters to a reasonable level. This case study will present the throughput comparison of virus filters from four different vendors using multiple mAb feed streams. Development of cost effective prefiltration strategy will be discussed to improve the throughput of virus filters.

16:30 - 17:00 30 mins
Differential Retention of Parvoviruses During Virus Filtration
  • Thomas Nowak - Senior Manager, Viral Validation, CSL Behring, Germany

Different animal parvoviruses are in use for spiking studies to determine the reduction capacity of virus filtration processes for small viruses. The use of MVM (Minute Virus of Mice) and PPV (Porcine Parvovirus) is common but also BPV (Bovine Parvovirus) and CPV (Canine Parvovirus) are used. The current assumption is that virus filtration reduction factors obtained with different model viruses are comparable as the size of these parvoviruses is very similar. We have performed studies comparing reduction factors obtained with different parvovirus models designed as separate as well as co-spiking studies. Our studies show that co-spiking is a valid approach to study the influence of the species of parvovirus used on the reduction factor obtained. Our studies show that the virus reduction factor obtained can be significantly influenced by the choice of parvovirus model and is dependent upon the filter type and filtration conditions. The impact of these results on the choice of parvovirus model used for virus validation studies and on the design of the virus filtration process developed is discussed.

17:00 - 17:10 10 mins
Plenary Changeover
17:10 - 17:40 30 mins
Closing Plenary - Next Generation Bioprocessing - A Representative from Sartorius
17:40 - 19:40 120 mins
End of Conference Day Two and Evening Entertainment