01.25.23 -- Considerations For Partnering With A Cell & Gene Therapy CDMO

Access to plasmid is a significant obstacle in downstream biopharma manufacturing. Capacity, manufacturing instability, and issues identified post-sequencing are important considerations for companies looking to streamline development efforts. Partnering with a CDMO that performs in-house plasmid production provides the opportunity to create efficiencies.

The keys to success are establishing appropriate strategies and fundamental testing, expecting additional regulatory requests, being prepared for assay variability, recognizing the limits of current understanding, and ensuring that comparability studies will be possible by retaining material from preclinical batch runs and stability studies.

Gene therapy is the process of replacing damaged or unhealthy genetic material with new material for treating various diseases and conditions. Curious to learn more about the process of gene therapy manufacturing? Explore the steps that go into manufacturing a gene therapy treatment.

It’s not just about scheduling, capacity, and terms. In this Q&A, an industry expert shares his views on overlooked considerations when partnering with a CDMO and the challenges of building a new facility during a pandemic.