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Join us for the next webinar series

Vaccine Production:
Securing process quality with flexible manufacturing solutions

November 3rd to November 19th 

Webinars Available

Vaccines development, regulations and manufacturing Part-1

  • Tuesday, Sep 22 - 08:00 PDT | 11:00 EDT | 16:00 BST | 17:00 CEST
  • Thursday, Sep 24 - 08:00 CEST | 11:30 IST | 14:00 SGT | 15:00 JST
  • Tuesday, Oct 06 - 08:00 PDT | 11:00 EDT | 16:00 BST | 17:00 CEST
  • Thursday, Oct 22 - 08:00 CEST | 11:30 IST | 14:00 SGT | 15:00 JST
Duration:
1 Hour
Summary:

This two-part webinar will focus on vaccines and an overview of their science, technology and, manufacturing processes. In Part 1, we will focus on the timelines and organizations involved, regulatory, quality and safety testing, and the different components and activities that contribute to their development including, antigens and adjuvants. The strategies and different philosophies which facilitate process optimization and scale-up, such as QbD and how the cost of a vaccine is assessed will also be studied.

Speakers:
...

Presenter:

Stephen Brown

Stephen is a consultant based in France with 40 years experience in the biopharmaceutical industry. Formerly, he was Executive Director, BE Vaccines, Nantes, France, and IPV Project Champion for the parent company, Biological E Ltd, Hyderabad, India. Steve holds a BSc in Microbiology from University of Cardiff and a PhD in Fermentation Technology from University of Kent at Canterbury, UK. His Postdoctoral was at the Institut für Biotechnologie, ETH Zurich, Switzerland. Steve’s career has focused on human and animal vaccines and gene medicines product development including, process development, GMP manufacturing, site management, manufacturing facility design and construction, Single-use Technology implementation and exploitation and partnership management. Prior to joining Biological E. Ltd, he previously worked at, G.D Searle (UK) and Transgene, Merial and Vivalis/Valneva (USA/France). Steve is a member of PDA, ISPE and ASTM and joint author of PDA SUS TR66. He was previously a board member of the Bio-Process Systems Alliance and Co-Chair of BPSA's European Advisory Council.

...

Moderator:

Helene Pora

VP Technical Communication & Regulatory Strategy
Pall Biotech

Helene has been instrumental in the development of Pall single-use technologies for the last 20 years, while getting heavily involved in manufacturing, quality and regulatory aspects. She has over 30 years of experience working for the biopharmaceutical industry, the last 29 years within Pall Corporation. She speaks regularly at conferences about single-use technology with a strong focus on validation and overall process integration aspects. She is also involved in different industry interested group with a strong focus on BPOG, and she is sitting on the board of BPSA.
...

Speaker:

David Johnson

Pall Biotech

Senior Global Product Manager, Continuous Purification

Sudhakar Nagaraj has been in the Pharmaceutical industry for over 17 years and joined Pall during 2006 in the Scientific Laboratory Services (SLS) organization.
...

Speaker:

David Johnson

Pall Biotech

Senior Global Product Manager, Continuous Purification

Sudhakar Nagaraj has been in the Pharmaceutical industry for over 17 years and joined Pall during 2006 in the Scientific Laboratory Services (SLS) organization.

Vaccines development, regulations and manufacturing

  • Tuesday, Oct 06 - 08:00 PDT | 11:00 EDT | 16:00 BST | 17:00 CEST
  • Thursday, Oct 08 - 08:00 CEST | 11:30 IST | 14:00 SGT | 15:00 JST
  • Tuesday, Oct 06 - 08:00 PDT | 11:00 EDT | 16:00 BST | 17:00 CEST
  • Thursday, Oct 22 - 08:00 CEST | 11:30 IST | 14:00 SGT | 15:00 JST
Duration:
1 Hour
Summary:

In Part 2, we will review vaccine processes with examples based upon influenza vaccine, inactivated Polio vaccine and an overview of the different types of vaccine production processes from cell expansion, USP and DSP, to the formulation and filling operations to make the finished product. We will talk about vaccine production facilities, how equipment is integrated their operating principles and biological safety levels for containment. Finally, we will look at the vaccine industry today, the supply chain and globalization, and how important vaccines are in pandemic preparedness, availability, and time to market. 

Speakers:
...

Presenter:

Stephen Brown

Stephen is a consultant based in France with 40 years experience in the biopharmaceutical industry. Formerly, he was Executive Director, BE Vaccines, Nantes, France, and IPV Project Champion for the parent company, Biological E Ltd, Hyderabad, India. Steve holds a BSc in Microbiology from University of Cardiff and a PhD in Fermentation Technology from University of Kent at Canterbury, UK. His Postdoctoral was at the Institut für Biotechnologie, ETH Zurich, Switzerland. Steve’s career has focused on human and animal vaccines and gene medicines product development including, process development, GMP manufacturing, site management, manufacturing facility design and construction, Single-use Technology implementation and exploitation and partnership management. Prior to joining Biological E. Ltd, he previously worked at, G.D Searle (UK) and Transgene, Merial and Vivalis/Valneva (USA/France). Steve is a member of PDA, ISPE and ASTM and joint author of PDA SUS TR66. He was previously a board member of the Bio-Process Systems Alliance and Co-Chair of BPSA's European Advisory Council.
...

Moderator:

Helene Pora

VP Technical Communication & Regulatory Strategy
Pall Biotech

Helene has been instrumental in the development of Pall single-use technologies for the last 20 years, while getting heavily involved in manufacturing, quality and regulatory aspects. She has over 30 years of experience working for the biopharmaceutical industry, the last 29 years within Pall Corporation. She speaks regularly at conferences about single-use technology with a strong focus on validation and overall process integration aspects. She is also involved in different industry interested group with a strong focus on BPOG, and she is sitting on the board of BPSA.
...

Speaker:

David Johnson

Pall Biotech

Senior Global Product Manager, Continuous Purification

Sudhakar Nagaraj has been in the Pharmaceutical industry for over 17 years and joined Pall during 2006 in the Scientific Laboratory Services (SLS) organization.
...

Speaker:

David Johnson

Pall Biotech

Senior Global Product Manager, Continuous Purification

Sudhakar Nagaraj has been in the Pharmaceutical industry for over 17 years and joined Pall during 2006 in the Scientific Laboratory Services (SLS) organization.

Developing scalable upstream workflows for recombinant and viral vaccine processes

  • Watch On Demand
  • Tuesday, Oct 06- 08:00 PDT | 11:00 EDT | 16:00 BST | 17:00 CEST
  • Thursday, Oct 22 - 08:00 CEST | 11:30 IST | 14:00 SGT | 15:00 JST
Duration:
1 Hour
Summary:

Vaccine manufacturing is responding to challenges for increasing safety assurance and responsiveness in order to reduce the impact of pandemic such as SARS-CoV-2. Therefore, in-depth knowledge of microorganism pathogenicity leads to develop new type of vaccines such as recombinant and viral vaccines. In this presentation we will review the current main upstream vaccine production processes, considering the choice of expression system, the means by which the biological preparation is introduced into the production cell and how Pall’s flexible single-use bioreactors support rapid process development, scale-up and safeguard the quality of life-protecting vaccines and help assure compliance with cGMP.

Speakers:
...

Presenter:

Andreia Pedregal

Bioreactor Applications Manager (EMEA), Scientific and Laboratory Services
Pall Biotech

Andreia is the manager of the Pall Bioreactor Application Scientist team in Europe. In her role she supports clients implementing Pall’s bioreactors for development and manufacturing of therapeutics focused on cell and gene, oncolytic, vaccine, monoclonal antibody therapies and others. Andreia holds a Master’s degree in Biotechnology Engineering from the Science and Technology Faculty of Algarve University, Portugal. She has over 10 years of experience in mammalian cell culture, and bioprocess design and optimization, acquired in her previous positions at the Laboratory of Animal Cell Biotechnology and Laboratory of Experimental Medicine at the private research university, ULB, in Brussels, Belgium.

...

Presenter:

Odette Becheau

Principal Scientist, Scientific and Laboratory Services
Pall Biotech

Odette joined Pall 4 years ago and is currently Principal Bioprocess Application Specialist within Pall Biotech’s Sales and Laboratory Services organization. Her role is to support customer to optimize, scale-up and transfer processes to produce stem cells, viral vectors and virus vaccines for preclinical and clinical grade manufacturing.

She has 6 years of experience within the vaccine industry including positions in both R&D and Manufacturing groups at GSK Vaccines. She obtained her Master Degree in Biotechnology Engineering at Bordeaux Engineering Institute of Biotechnology, in France.
...

Moderator:

Helene Pora

VP Technical Communication & Regulatory Strategy
Pall Biotech

Helene has been instrumental in the development of Pall single-use technologies for the last 20 years, while getting heavily involved in manufacturing, quality and regulatory aspects. She has over 30 years of experience working for the biopharmaceutical industry, the last 29 years within Pall Corporation. She speaks regularly at conferences about single-use technology with a strong focus on validation and overall process integration aspects. She is also involved in different industry interested group with a strong focus on BPOG, and she is sitting on the board of BPSA.
...

Speaker:

David Johnson

Pall Biotech

Senior Global Product Manager, Continuous Purification

Sudhakar Nagaraj has been in the Pharmaceutical industry for over 17 years and joined Pall during 2006 in the Scientific Laboratory Services (SLS) organization.

Downstream process development for vaccine manufacturing

  • Watch On Demand
  • Tuesday, Oct 06 - 08:00 PDT | 11:00 EDT | 16:00 BST | 17:00 CEST
  • Thursday, Oct 22 - 08:00 CEST | 11:30 IST | 14:00 SGT | 15:00 JST
Duration:
1 Hour
Summary:

The purification of vaccines and gene therapy/viral vector products is a key part of a drug manufacturing process that requires high levels of product purity and process reproducibility. Pall has a range of technologies and offers field-based support and lab-based process development services that enable end users to purify and recover their high-value products. The process strategies to improve purity and yield as well as the challenges associated the purification of viral vector process will be discussed.

Speakers:
...

Presenter:

Jon Petrone

Senior Director, Process Development Services and Scientific Laboratories Services Consultancy Teams supporting Purification, Viral Vector and Gene Therapy Technologies
Pall Biotech

Jon leads Pall Biotech’s Process Development Services (PDS) and SLS consultancy teams supporting purification, viral vectors, and gene therapy technologies. The PDS team provides upstream, downstream, and analytics process development, scale-up, and tech transfer services to support emerging therapeutics such as gene/cell therapies (and proteins) as well as supporting new manufacturing methods such as continuous bioprocessing. The SLS consultancy teams provides field-based customer and technical support that utilizes Pall’s technologies and products to create process solutions for the production and purification of biopharmaceutical products, such as viral vectors, monoclonal antibodies and gene therapy products. He has over 35 years of experience supporting downstream purification applications from cell harvest through final bulk fill. Prior to joining Pall 15 years ago, Jon was responsible for the process development and clinical/commercial support of the membrane based separations and centrifugation steps at Wyeth BioPharma. Previously, he held various applications/product development and system sales roles at Millipore.
...

Moderator:

Helene Pora

VP Technical Communication & Regulatory Strategy
Pall Biotech

Helene has been instrumental in the development of Pall single-use technologies for the last 20 years, while getting heavily involved in manufacturing, quality and regulatory aspects. She has over 30 years of experience working for the biopharmaceutical industry, the last 29 years within Pall Corporation. She speaks regularly at conferences about single-use technology with a strong focus on validation and overall process integration aspects. She is also involved in different industry interested group with a strong focus on BPOG, and she is sitting on the board of BPSA.
...

Speaker:

David Johnson

Pall Biotech

Senior Global Product Manager, Continuous Purification

Sudhakar Nagaraj has been in the Pharmaceutical industry for over 17 years and joined Pall during 2006 in the Scientific Laboratory Services (SLS) organization.
...

Speaker:

David Johnson

Pall Biotech

Senior Global Product Manager, Continuous Purification

Sudhakar Nagaraj has been in the Pharmaceutical industry for over 17 years and joined Pall during 2006 in the Scientific Laboratory Services (SLS) organization.

Implementing single-use technologies in formulation and filling of vaccines

  • Watch On Demand
  • Tuesday, Oct 06 - 08:00 PDT | 11:00 EDT | 16:00 BST | 17:00 CEST
  • Thursday, Oct 22 - 08:00 CEST | 11:30 IST | 14:00 SGT | 15:00 JST
Duration:
1 Hour
Summary:

Formulation and filling is a critical part of any drug manufacturing process and demands the highest levels of quality and reliability. Pall has a range of technologies and services that enables end users to carry out their operations with increased reliability and flexibility – while ensuring the product quality is designed into the manufacturing process. Using technology from the Allegro™ single-use portfolio, Pall sterilizing grade filters and Pall’s automated solutions ensure that manual interventions are minimized and increased sterility assurance is achieved.

Speakers:
...

Presenter:

Patrick Evrard

Senior Principal Engineer Single-Use Technologies,
Technical Communication and Regulatory Strategy
Pall Biotech

Patrick joined Pall Biotech in 2017, to provide expert technical support to Pall Biotech's customers on single-use systems. He joined end 2018 the Technical Communication and Regulatory Strategy team, combining the technical content with validation and regulatory perspectives.
Before joining Pall, he led for more than 10 years a global technical team in charge of developing and implementing single-use technologies in GSK Vaccines' commercial manufacturing operations. Patrick and his team implemented at global level single-use technologies in critical sterile applications and re-engineered several vaccines processes, switching from classical grade A open processes to closed systems.
...

Moderator:

Helene Pora

VP Technical Communication & Regulatory Strategy
Pall Biotech

Helene has been instrumental in the development of Pall single-use technologies for the last 20 years, while getting heavily involved in manufacturing, quality and regulatory aspects. She has over 30 years of experience working for the biopharmaceutical industry, the last 29 years within Pall Corporation. She speaks regularly at conferences about single-use technology with a strong focus on validation and overall process integration aspects. She is also involved in different industry interested group with a strong focus on BPOG, and she is sitting on the board of BPSA.
...

Speaker:

David Johnson

Pall Biotech

Senior Global Product Manager, Continuous Purification

Sudhakar Nagaraj has been in the Pharmaceutical industry for over 17 years and joined Pall during 2006 in the Scientific Laboratory Services (SLS) organization.
...

Speaker:

David Johnson

Pall Biotech

Senior Global Product Manager, Continuous Purification

Sudhakar Nagaraj has been in the Pharmaceutical industry for over 17 years and joined Pall during 2006 in the Scientific Laboratory Services (SLS) organization.

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