BPI Contributor

December 15, 2018

20 Min View
Enabling Success in Biologic Drug Substance Development and Biomanufacturing by Leveraging Expertise and Collaboration

Date: Dec 14, 2018

Duration: 20 Min

This webcast features: Steven Perry, PE, Senior Director of Manufacturing Sciences, Catalent Biologics

Biologic drug substance development and biomanufacturing is a critical step in the long, complex pathway to approval. There are many considerations to be made around cell line and process development, analytical testing and late stage activities such as process characterization and validation.

This presentation discusses:

  • Critical drug substance resource needs of sponsor companies

  • How expertise and collaboration amongst the key stakeholders enables successful development and scale up

  • Thinking ahead to what will be needed for successful Drug Product development and fill/finish

Watch the recorded webcast below.

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