Dr. Behnam Ahmadian Baghbaderani will be highlighting the current challenges associated with industrialization of cell therapies and explain how Lonza is addressing these challenges. In particular, he will be focusing on some of the best practices of process development and analytical method development with emphasis on a streamlined, phase appropriate, step by step development approach for cell and gene therapies established at Lonza. He is going to explain what would be the benefits of appropriate process development activities and partnering to de-risk the manufacturing of cell therapies and pave the way for future commercialization.

Speakers:

Behnam Ahmadian Baghbaderani
Global Head of Process Development, Cell & Gene Technologies
Lonza

Session Description is Coming Soon!

Speaker:

Anne- Sophie Lebrun
Head of Operations
Bone Therapeutics, Belgium

Viral vector quantification using conventional immunoassays suffers from narrow dynamic ranges, large sample volumes, and laborious procedures. In this webcast, we present data on the high-precision, automated microfluidic immunoassays for the quantification of AAV and lentiviral vectors in bioprocessing applications. Examples of the rapid implementation of AAV titer assays are presented for multiple AAV serotypes.

Speaker:

Rob Durham, PhD
Director of Service and Scientific Support
Gyros Protein Technologies

We present the design of a media fill study protocol using sterile growth medium in place of cord blood for validation of aseptic processing. Growth media are pre-qualified for ability to support growth of relevant microorganisms as visualized in media turbidity assays. Annual completion of media fills are required for all active processing staff to verify use of proper aseptic techniques, executed under ‘worst-case’ conditions stressing the system. Dynamic environmental and personnel monitoring is included to detect actual contamination risks during the media fills. After processing, all simulated products and controls are incubated and examined for media turbidity. The acceptable failure rate (i.e. observation of turbidity) is defined as zero (0%). This media fill program was approved by FDA to support the manufacture of HPC, Cord Blood under license. As such, our experience can provide insight into the regulatory expectations for media fill protocols for growing assortments of cellular therapeutics under development towards regulatory approval in the industry.

Speaker:

Wouter Van’t Hof
Director, Processing Facility & CEO
Cell Therapy Incubator, Cleveland Cord Blood Center, USA wvanthof@clevelandc

Dr. Jef Pinxteren, Director of Process and Analytical Development at Catalent Cell and Gene Therapy, will discuss a breadth of analytical methodologies facilitating manufacturing design and accelerating CAR-T therapies to commercial readiness phase.

• Attendees will be able to gain insight into:
• Benefits of working with a full-service provider of analytical methods
• Strategy and process flow from analytical assay development to GMP implementation for clinical and commercial manufacturing
• Emerging strategies for cell therapy product identification, characterization and potency testing using state-of-the-art technologies
• Definition of framework for analytical method validation ensuring fast batch release

Speaker:

Dr. Jef Pinxteren
Director of Process and Analytical Development
Catalent Cell and Gene Therapy

Session Description is Coming Soon!

Speaker:

Matthew Pennington, PhD
Scientist 1
Biologics Testing Solutions, Charles River Laboratories

Advanced therapy medicinal product (ATMP) characterization and analysis play an important role in providing CMC information and supporting release and stability studies. Cell and patient variability, multiple MOAs, lack of reference materials and complex analytical methods and instruments underlie some of the difficulties of developing analytical methods. The presentation will present different assays for characterization, potency, purity and identity testing and will follow different analytical challenges, from the development stage up to validation, including case studies.

Speaker:

Ruti Goldberg
Compliance & Methods Validation Manager
Pluristem Therapeutics Inc., Israel

Learn in this webinar how to:

• Close the production gap for AAV gene therapy vectors by using ELEVECTA® stable helper virus-free AAV producer cell lines
• Eliminate any transient transfection step from your AAV production process
• Achieve reliable AAV production by simple induction of suspension producer cells
• Optimize scale-up production of AAV in stirred tank bioreactors

Speaker:

Dr. Silke Wissing
Chief Scientific Officer
CEVEC Pharmaceuticals GmbH

NK cells have become to new focus point of the cell therapy industry. Kiadis Pharma is developing an off the shelf NK cell therapy platform for multiple indications in oncology and infectious disease. Development of such a platform and the potential to scale this to biologics industrial scale require a solid CMC strategy already in early phase. This talk will provide an overview of the most important CMC considerations which should be addressed from the start. Specifically for:

• Starting materials
• Expansion process: towards a homogeneous cell suspension
• Analytical panel: flow assays, biochemical assays, cell-based assays
• Filling and Freezing

Speakers:

Mathieu Streefland
Vice President CMC Development
Kiadis, The Netherlands