The CDMO Capacity Crunch featuring Center for Breakthrough Medicines’ Audrey Greenberg and Iovance Biotherapeutics’ Sumit Verma
“On this episode of the Business of Biotech, we’re tackling the CDMO capacity crunch from every angle in a spirited discussion with Discovery Labs & Center for Breakthrough Medicines Co-Founder Audrey Greenberg, Iovance SVP of Commercial Manufacturing Sumit Verma, and Project Farma CEO Anshul Mangal.”
(Listen to Podcast Below)
A right-first-time approach to development
By Tatiana Nanda, Director and Program Leader and Brian Tomkowicz, Sr. Director, Vector Engineering & Manufacturability, Center for Breakthrough Medicines
The industrialization of cell and gene therapies (CGTs) is a prominent issue in the biopharma industry. These novel medicines have rapidly advanced to the stage where both significant efficacy and safety have been achieved in the clinic. Unfortunately, the existing manual, labor-intensive, open lab-scale manufacturing solutions for viral vector production and genetic modification of cells are not practical to properly commercialize these innovations.
Challenges In Analytical Development And Testing For Gene Therapies
(Guest Column by Stephen Gacheru, Ph.D., Vice President, Analytical Development and Technical Operations at Center for Breakthrough Medicines)
The objective is confidence in our ability to develop and optimize assays specific to a specific investigational drug, used for a specific disease and delivered in a specific way.
The Center for Breakthrough Medicines approaches potency assays for gene therapies through a “matrix” approach that involves capturing two or more mechanisms of action to compile data with the goal of reaching a collective conclusion regarding final product potency. Our strategy involves the following assays:
- Virus product strength by ddPCR and infectivity through ddPCR. We have developed platform assays for these two techniques which we are now preparing for validation.
- Translation Potency via ddPCR. By following expression of the gene of interest to the mRNA stage, we can detect mRNA as part of early development potency assays.
- Expression of polypeptide chains via ELISA, using a representative green fluorescent protein sample analysis to set up a template assay design.
- Functional protein potency assay through ELISA, based on disease mechanism of action (MOA).
Center for Breakthrough Medicines Taps Joerg Ahlgrimm as new CEO
With a goal of expanding manufacturing capabilities to meet the growing demands of cell and gene therapy production, The Center for Breakthrough Medicines (CBM) promoted Chief Operating Officer Joerg Ahlgrimm to the role of Chief Executive Officer.
Ahlgrimm joined CBM last year after serving as Head of Global Operations Pharma Biotech and Nutrition at Lonza. CBM, located within the Discovery Labs campus in suburban Philadelphia, is a quickly growing contract development and manufacturing organization that aims to provide pre-clinical through commercial manufacturing capabilities for client companies. CBM’s offerings include process development, plasmid DNA, viral vectors, cell banking, cell processing, and supporting testing capabilities.