Fitting product to process: raw materials customization for cell therapy manufacturing success

The reliable supply of raw materials is critical for developing successful cell and gene therapies. While the cell and gene therapy industry has made strides to ensure regulatory compliance and patient safety, the challenges surrounding scalability and consistency of raw materials remain. Often, GMP-compliant raw materials either do not currently exist or are only available “off the shelf”. Any required in-house modifications to these materials increase the possibility of user error and add complexity when scaling up the process.

This webinar will showcase how customization at the raw material level enables cell therapy manufacturers to be confident in the security of their supply, de-risk manufacturing processes, and improve their scalability.

In the first segment of this webinar, we will discuss case studies that highlight the impact of customization on successful manufacturing processes. The second segment of the webinar will focus on a discussion related to how the right suppliers can fit products to manufacturers’ process to help expedite the path to commercialization.

Attendees will learn:

• How tailoring raw materials' specifications to fit the process can de-risk manufacturing processes and remove unnecessary manual steps
• Why early consideration of custom raw materials expedites development and commercialization
• Methods to minimize operator interaction with raw materials to close the process
• Considerations for the selection of raw materials prior to clinical manufacturing
• How to source raw materials in cases where the GMP-grade versions do not currently exist

John Paul Tomtishen III

Director of Manufacturing, Technical Operations at Legend Biotech Co.

John Paul Tomtishen III is currently employed by Legend Biotech where he serves as the Site Managing Director of Legend's corporate headquarters in Somerset, NJ and is responsible for Legend's back office functions, including Engineering/Facilities and Sourcing/Procurement. John also has oversight over Legend's US Manufacturing and Technical Operations teams and is responsible for developing robust global CMC strategies to ensure best-in-class, end-to-end manufacturing and supply chain capabilities for Legend's cell and gene therapy product portfolio.

Lindsey Clarke PhD

Global Product Marketing & Commercial Strategy, Cell & Gene Therapy, Bio-Techne

Lindsey has spent the last decade working in Cell and Gene Therapy on the raw materials supplier side prior to running Bio-Techne’s Global Cell and Gene Therapy Product Marketing team. She joined Bio-Techne in 2018 to establish their European Cell and Gene Therapy specialist team and has recently transitioned into a global role. She is focused on building the team to support customers applications, planning the roll out of new innovations, and developing strategic partnerships within the industry. Prior to this she was in Miltenyi Biotec’s UK field team, working closely with numerous process development and manufacturing teams to assist in translating their varied cell therapies to the clinic. Lindsey holds a first-class degree in Pharmacology from the University of Bath, a PhD in Immunology from UCL and worked as a postdoctoral scientist at Imperial College before moving into more commercial roles.

Lili Belcastro PhD

Scientist, Biotherapeutics Material Sciences,Janssen Pharmaceutical R&D

Lili Belcastro is a Scientist at Janssen and is responsible for the qualification of raw materials used in Janssen’s cell and gene therapy products. Dr Belcastro has over 10 years of experience in preclinical and clinical cancer biology, cell and gene therapy product development, and analytical method development. Prior to joining Janssen in 2017, she was finishing her PhD in cancer biology in a joint program with the University of the Sciences and The Wistar Institute in Philadelphia. Prior to joining industry, Dr. Belcastro led pediatric, preclinical, in vivo testing programs at the Children’s Hospital of Philadelphia for small molecule inhibitors, oncolytic viruses, antibody-drug conjugates, and radiopharmaceuticals. Dr. Belcastro holds two bachelor’s degrees from Temple University and the University of the Sciences.

Raymond Luke

Associate Director, MS&T, Adaptimmune

Associate Director of Process Sciences, Adaptimmune Raymond Luke has over 10 years of industry experience in life sciences. He leads a team that is responsible for process characterization, product characterization and process engineering. He plays a key role in selecting material for both development and cGMP uses.

Mitchell Brabec

Commercial Development Specialist, Bio-techne

Since 2015, Mitch has filled multiple roles within Bio-Techne prior to joining the Commercial Development group. He began in Technical Support to support Research Use Only (RUO) and Good Manufacturing Practices (GMP) products for academic and industrial clients, followed by Product Marketing in the Protein Business Unit for RUO and GMP proteins. As a Commercial Development Specialist with the Custom Projects team, he helps clients find solutions for their workflows by managing GMP conversion, custom protein modifications and GMP fill-finish projects. Mitch works closely with Bio-Techne’s development scientists and expert quality and regulatory groups.

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SPEAKERS

John Paul Tomtishen III

Director of Manufacturing, Technical Operations at Legend Biotech Co.

Lindsey Clarke PhD

Global Product Marketing & Commercial Strategy, Cell & Gene Therapy, Bio-Techne

Lili Belcastro PhD

Scientist, Biotherapeutics Material Sciences,Janssen Pharmaceutical R&D

Raymond Luke

Associate Director, MS&T, Adaptimmune

Mitchell Brabec

Commercial Development Specialist, Bio-techne

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