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Key Sessions

Itzcoatl Pla

Keynote: Operating in a Disruptive Bioprocessing Landscape – Next Generation Bioprocessing Technologies, Facility Design and Products to Improve Process Productivity and Increase Capacity

Bristol-Myers Squibb, USA

08:20 - 08:30 10 mins
Chairperson's Opening Remarks
08:30 - 09:00 30 mins
Info
Plenary
Examining the Advances and Challenges in Vaccine Development and Manufacture
  • Tony D'Amore, PhD, MBA - Vice President, Product Research and Development, Sanofi Pasteur

This presentation will review the constraints and complexities of vaccine product development and manufacture.  With this increasing complexity, higher costs and competition; evolutions in bioprocess and analytical technologies to accelerate and overcome these challenges are reviewed.  Strategies to leverage innovation and technology for rapid product development and increasing productivity are discussed.  Specific examples are provided, as well as emerging technologies, such as continuous manufacture.

09:00 - 09:30 30 mins
Plenary
Keynote: Operating in a Disruptive Bioprocessing Landscape – Next Generation Bioprocessing Technologies, Facility Design and Products to Improve Process Productivity and Increase Capacity
  • Itzcoatl Pla - Head of Global MS&T Capabilities, Bristol-Myers Squibb, USA
09:30 - 10:00 30 mins
Info
Plenary
Challenges of implementing virus filtration in continuous manufacturing
  • Sebastian B. Teitz - Product Manager & Scientific Coordinator, Asahi Kasei Bioprocess

Continuous processing may transform manufacturing of biotherapeutics through improvements to cost and quality. As a flow-through operation, virus filtration (VF) seems adaptable to this paradigm, but impacts of dynamic conditions on viral clearance & performance of VFs is being investigated. Continuous VF operations require new approaches to viral clearance validation and this presentation explores its design and illustrates the impacts of potential continuous process conditions on viral clearance.

10:00 - 10:45 45 mins
Morning Coffee
10:45 - 10:50 5 mins
NGS and Virus Detection - Applications and Strategies
Chairperson's Opening Remarks
  • Aaron Mack - Engineer III, Biogen
10:50 - 11:20 30 mins
NGS and Virus Detection - Applications and Strategies
Next generation sequencing efforts at CBER
  • pending final confirmation Arifa Khan - Supervisory Microbiologist, FDA
11:20 - 11:50 30 mins
NGS and Virus Detection - Applications and Strategies
Testing strategies for adventitious agents: impact of NGS introduction
  • Laurent Mallet - Senior Director, Product Conception and Development, Sanofi-Pasteur
11:50 - 12:20 30 mins
Info
NGS and Virus Detection - Applications and Strategies
Adventitious Virus Detection in Cells by High-Throughput Sequencing (HTS) of Newly Synthetized RNAs: Unambiguous Differentiation of Cell Infection from Carryover of Viral Nucleic Acids
  • Marc Eloit - Scientific Advisor, Professor at Institut Pasteur, Pathogen Discovery Lab, PathoQuest

The use of High Throughput Sequencing to identify viruses in biologicals differs from current molecular approaches since its use enables an unbiased approach to detection without the need to design specific primers to preamplify target sequences. Its broad range of detection and analytical sensitivity make it an important tool to insure biologicals are free from viruses. Similar to other molecular methods, however, identification of viral sequences in cells by HTS does not prove cell infection since this could reflect carryover of inert viral sequences from reagents or other sources. Due to the broad range of detection associated with HTS, the above can be potentially perceived as a drawback for the testing of pharmaceutical biological. In order to avoid the identification of inert viral sequences, we present a methodology based on metabolic RNA labelling and sequencing which enables the specific identification of newly synthetized viral RNAs in infected cells resulting in the ability to unambiguously distinguish cellular infection by DNA or RNA viruses from carryover of inert nucleic acids. In the present study we report as a proof of concept the ability to differentiate Vero cells acutely infected by a single-stranded positive RNA virus (Tick Borne Encephalitis Virus) from cells which have been in contact with non-replicating virus particles. Additionally, we also found an unexpected Squirrel Monkey retrovirus in our Vero cell line.

In addition to testing of cells for adventitious virus, the method has very broad applications because it can be used each time cell infection must be detected in a background of inert viral sequences: read-out of virus bioassays for raw materials like Bovine Serum, testing for vaccine inactivation, searching for revertants in replication-defective virus stocks. It can also be extended to the bacterial world (testing for mycoplasma).

12:20 - 13:35 75 mins
Lunch and Networking
13:35 - 14:05 30 mins
Info
NGS and Virus Detection - Applications and Strategies
Rapid Methods for Adventitious Virus Detection and Sterility Assurance: How can we achieve broad adoption?
  • Cristina Barbirato - Senior Scientist - Scientific and Regulatory Expertise of BQC Biopharma,, Merck MSD

As part of the BioPhorum Technology Roadmapping Phorum, Project “RAVnS” is focused on Rapid methods for Adventitious Virus Detection and Sterility Assurance.

This project contributes to the goals of the BioPhorum 1st edition BioManufacturing Technology Roadmap to reduce production lead time by reducing product lot release times from weeks with current methods to days with innovative methods.

Team members consist of industry professionals from over 10 biopharmaceutical companies who are all interested in driving the adoption of potential solutions.


To collate information on current testing regimes and interest/activities in rapid innovative methods surveys were conducted. Questions included identifying the main point of dissatisfaction with current methods are, barriers to adoption, and what activities would be useful in driving adoption of regulatory compliant release testing. Because the expectation is that methods will continue to evolve, the survey purposely did not focus on technology platforms, but rather focused on generic points to consider for implementing new methods which will serve as the basis for today’s and future methods.


Participants of the survey were identified and selected by the group to be subject matter experts in this topic. Comments and results from the survey are presented herein.

14:05 - 14:35 30 mins
NGS and Virus Detection - Applications and Strategies
Next-Generation Sequencing vs Traditional Methods: Considerations and Proof of Concept Data for the Development of a Next-Generation Sequencing Method for Adventitious Virus Detection
  • Maria Bednar - Scientist I, AT Virology, Biogen, USA
14:35 - 15:05 30 mins
Risk Assessment, Facility Design and Segregation
Viral Segregation Strategy for Flexible Manufacturing Facility Designs
  • Bonnie Shum - Senior Engineer, Global Biologics Manufacturing Sciences and Technology (MSAT), Genentech
15:05 - 15:35 30 mins
Info
Risk Assessment, Facility Design and Segregation
Consideration for Biosafety testing of viral vectors and vaccines.
  • Richard Adair - Virology and Technical Support Manager, SGS Virology

Regulatory authorities such as the US Food & Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA) impose stringent limits on the amount of microbial contaminates and impurities present during the manufacturing of biological medicines, including viral vectors and vaccines. These regulations ensure sterile products and thus patient safety. To establish that the testing procedures are accurate, regulatory authorities require proof of testing before clinical trials can be approved or a batch of commercial biopharmaceuticals or viral vaccines be released. Consequently, all components of the manufacturing process must undergo extensive safety testing to demonstrate identity, stability, and purity.  This talk will examine the considerations for biosafety testing of viral vectors and vaccines.

15:35 - 16:20 45 mins
Afternoon Coffee
16:20 - 16:50 30 mins
Emerging and Existing Viruses of Concern
Circulation of HEV in Europe – implications for blood / plasma product safety
  • Maria Farcet - Scientist, Global Pathogen Safety, Takeda
16:50 - 17:20 30 mins
Emerging and Existing Viruses of Concern
Modernizing Lyophilization of Pharmaceuticals in Unit Doses Via Continuous Manufacturing
  • Roberto Pisano - Associate Professor, Department of Applied Science and Technology, Politecnico di Torino
17:20 - 17:25 5 mins
End of Day Three
08:20 - 08:30

Chairperson's Opening Remarks

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10:00 - 10:45

Morning Coffee

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12:20 - 13:35

Lunch and Networking

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15:35 - 16:20

Afternoon Coffee

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Showing of Streams
17:20 - 17:25
End of Day Three

End of Day Three

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