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BioProcess International

The BioProcess International event is in Boston September 9-12, 2019 at the Boston Convent and Exhibition Center. More than 225 scientific case studies and new data presentations are scheduled across six tracks: Manufacturing Strategy and Bioprocessing 4.0; Cell Culture & Upstream Processing; Recovery & Purification; Analytical & Quality; Intensified & Continuous Processing; and Speed from Gene to Market.

Development of a Holistic Approach to Raw Material Risk Assessments Through Industry Collaboration

Kara Quinn, Associate Director of Global Technical Operations, Raw Material Center of Excellence, Merck & Co. (US)

Full Presentation: Monday, 9 September 2019 2:00-2:30

Kara Quinn, an associate director of global technical operations at Merck & Co. (US), will be presenting results of a Biophorum Operations Group (BPOG) working session on approaches to raw material risk assessments across the industry. While risks differ between companies, shared methodologies and best practices on qualifications of raw materials between companies have helped to set standards in a space that has relatively few direct regulatory guidelines.

Approach to Identify and Control Product Attributes in Cell Culture Perfusion Systems

Prasad Pathange, Senior Manager, Bayer US

Full Presentation: Wednesday, 11 September 2019 10:30-11:00

Prasad Pathange, a senior manager at Bayer US, spoke to us ahead of his presentation at BPI East. His talk, entitled "Approach to Identify and Control Product Attributes In Cell Culture Perfusion System," forms part of the Cell Culture & Upstream Processing track.

The presentation takes a look at a case study at Bayer where an out-of-trend specification was discovered during the analysis of a molecule being produced in a cell culture perfusion system.

Joined by the co-author of the study, Yuval Shimoni, Pathange talks about how Bayer’s findings may have wider implications across the industry, especially as perfusion becomes a more commonly used process.

Strategies for Efficiency and Optimization

Full Presentation: Tuesday, 10 September 2019 1:30-2:00

Process optimization allows us to reduce costs and not create the large, costly manufacturing footprints traditionally seen in the industry, Ciaran Brady, Executive Director, Manufacturing Science and Technology, Drug Substance at Bristol-Myers Squibb, said ahead of his talk at BPI East.

He spoke also about the competitive landscape and how optimized processes can push down the cost of drugs, as well as how firms like Bristol-Myers Squibb work with equipment vendors through strategic partnerships:

“I tend to think of that more as a partnership and not as a vendor-client relationship. Our suppliers are absolutely critical as an industry in this area,” he told us. “We really work together to advance these technologies.”

Case Study for Developability Assessment of Three Therapeutic Antibodies

Zhiping Yao, Director of Process Science, JOINN Biologics US
Full Presentation: Tuesday, 10 September 2019 10:45-11:15

Zhiping Yao, Director for Process Science at JOINN Biologics US, spoke with BioProcess Insider’s Dan Stanton ahead of her talk in the "Speed from Gene to Market" session at BPI Boston in September.

Her presentation focuses on carrying out developability assessments to progress therapeutic antibodies into and through the clinic. Described as "quality by design (QbD) for the discovery stage of drug development," these assessments can save months in the R&D life cycle and thus save developers money.

From Sequence to Product in Hours – Cell-Free Expression for Next-Generation Therapeutics

Phillip Probert, Senior Upstream Scientist, Centre for Process Innovation (CPI)
Full Presentation: Tuesday, 10 September 2019 16:30-17:00

Philip Probert, Senior Upstream Scientist at the UK’s Centre for Process Innovation (CPI), spoke to us ahead of his presentations at BPI Boston about cell-free expression systems for next-generation therapeutics. His firm has been looking at how cell-free systems can be standardized and then applied to a high throughput automated screening system in order to vastly improve titers beyond what’s currently possible to make it a more relevant system for manufacture.

CPI Biologics is looking to develop a cell free expression system for one of Ipsen BioPharma’s molecules, but Probert said the development of such a system could be used across the industry for next generation therapeutics, vastly improving the speed of production compared with microbial and mammalian platforms.