Evaluating Biopharma Podcast

Operational Efficiencies: Lower Operational Costs by Reducing Clinical GMP Sampling

October 11, 2022

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In this episode, Josefine Persson, Genentech associate director, and Ben Locwin, Black Diamond Networks vice president of project solutions, discuss how the cost of oversampling from clinical GMP runs versus development sources equates to high expenses and lost opportunities in moving a new project into GMP manufacturing.

Persson also talks about the role judicious sampling plays in testing and verifying process operations and how she worked with various Genentech departments to reduce product sampling volumes by more than 50 percent. She goes on to discuss the importance of changing the company mindset to encourage behaviors based on department needs rather than wants, especially with smaller indication products. Finally, Persson details how conservative clinical GMP sampling dramatically impacts direct and indirect costs, increases speed to market, and reduces environmental impact.


Josefine Persson, Associate Director, Genentech
Josefine Persson was born and educated in Sweden and earned her Ph.D. in Biochemistry from Lund University, Sweden. She earned her post-doc and has worked at Genentech, South San Francisco, for over 18 years. Persson has led development teams and served as CMC team leader for multiple projects. She has done extensive work and is an expert in E. coli-derived proteins, ADC, and bispecific antibodies. Currently, Josefine is managing critical reagent production at Genentech.

Sponsor:

 

Pendo-TechWith extensive experience in the biopharmaceutical industry—and particular expertise in single-use bio-pharmaceutical equipment—PendoTECH delivers a line of pressure sensors, control systems, and software for measuring, monitoring, and data collection in bioprocess applications and other areas where the products provide a unique process solution.

Since 2005, PendoTECH has been committed to meeting the specialized needs of life science laboratories and bio-pharmaceutical manufacturers. PendoTECH is proud to help advance innovation through user-friendly, adaptive process equipment for cutting-edge biopharma manufacturing and research applications.