South San Francisco

Lunch & Learn: Accelerating Recombinant Proteins to Clinical Trials

November 19, 2019
11:30AM-2:00PM PST
Thermo Fisher Scientific
180 Oyster Point Blvd.
South San Francisco, CA

As the molecules being developed become increasing complex, clinical trials for biological products require experience and specialized expertise. Recently, the FDA recently issued new guidelines for developers of bispecific antibodies.  For new and emerging biopharma companies, ensuring a successful IND filing in tight timelines with limited budgets is key to corporate success and survival. CDMO selection is a critical part of the journey from discovery to patient. 

Meet with our subject matter experts for a technical discussion titled Novel paradigms for driving speed to clinic in monoclonal antibody development and specialized solutions for complex recombinant proteins.

At this event, you will learn:

• New technologies and techniques for driving faster timelines in Cell Line Development and Process Development, increasing speed to IND
• The risks, implications, and pay-offs in making typical trade-offs when establishing a work scope for your Phase 1 process
• The challenges in process development and manufacturing of complex recombinant proteins, such as bispecifics and fusion proteins, and how to implement tailored approaches to process development for these new protein modalities
• Industry leading business and technical processes that are used to create customized bioprocess development solutions
• The cost and time benefits of an integrated supply chain of drug substance manufacturing, drug product manufacturing and packaging, labelling and distribution services.

You are invited to join us for an informative discussion on how to accelerate the path to early trials while satisfying regulatory guidelines, maintaining product quality and meeting safety requirements.