BioProcess International West

Ensure your manufacturing facility is applying industry 4.0 strategies to handle the rapidly expanding and evolving product pipelines, capacity demands and global markets by attending BioProcess International US West, held March 11-14, 2019 in Santa Clara, California.

Developing A Robust Downstream Process For Early Phase ADC Manufacturing Under Tight Timelines

Chi Zhang, Scientist, Ambrx
Full Presentation: Thursday, 14 March 2019 14:30–15:00

In this podcast, Zhang talks about Ambrx’s strategy to develop a robust process to manufacture early-stage antibody-drug conjugates (ADCs). She describes how developing upstream and downstream in parallel can save a lot of time, and how working closely with CDMOs ensure a quality platform. Designing the process under QBD is also important to consider, she says, especially when looking ahead to scaling-up.

Plug and Play Automation for Single Use Equipment

Eugene Tung, Executive Director of Manufacturing IT , Merck MSD
Full Presentation: Tuesday, 12 March 2019 14:15–14:50

His presentation focuses on plug and play automation in single-use, and in this podcast he explains how biomanufacturers look to connect single-use unit operations seemlesly without custome protocols or custom programming.

Working with the Biophorum Operations Group (BPOG), he is looking to come up with standard communications protocol with a common data model so that intelligent controllers can essentially plug-in via ethernet and speak directly with each other.

Next Generation Biomanufacturing and Facility Implementation: Technical Advances in Manufacturing Technologies to Improve Process Productivity

Parrish Galliher Chief Technology Officer of Upstream and Founder, of Xcellerex, a GE Healthcare Life Sciences Company
Full Presentation: Tuesday, 12 March 2019 10:00–10:30

In this podcast, Galliher says most vendors and biopharma companies today are approaching full productivity by debottling their processes. However, by taking this pragmatic approach, bottlenecks are being moved to other areas of the production line. Industry could take a more holistic approach to removing bottlenecks and increasing productivity, but regulatory uncertainty of acceptance and the risk of changing the quality of a product ensures changes are incremental and slow.

But “the ultimate bottleneck” is the way industry uses analytics, he says, measuring the quality and quantity of the product once it is produced rather than during the manufacturing process.

Modular Platform Delivery Considerations for Today’s New Drug Production Facilities: Case Studies from Recent Design Competitions

Peter Cramer, Vice President Life Science Facility Design, Exyte US
Full Presentation: Tuesday, 12 March 2019 13:45 - 14:15

In this podcast, Cramer talks about industry’s adoption of modular biomanufacturing platforms and facilities. “Speed is the big driver,” he said. “But it has to be at least cost comparative or cost neutral compared to a typical plant; in other words, we can’t just spend a whole lot more money to go fast.”

Speed and effective cost-savings can come about due to the standardization of these facilities, he continued, allowing effective and efficient scale-up and reliable forecasting for both end-users and CMOs

TBD

Qinghai Zhao, VP of Technical Development and Manufacturing, FortySeven Inc.
Full Presentation: Tuesday, 12 March 2019 13:45–14:15

In this podcast, Zhao talks about his experience of selecting and working with contract manufacturing organizations (CMOs) for early-phase development. Among his findings, he speaks about the importance to him of using a third-party that offers a one-stop-shop service. However, he notes, while many CMOs boast of offering this, there are really only a handful that offer truly end-to-end services.

"In my experience, if you find a CDMO which can provides a one-stop-shop service and also can do commercial launch, it will save you at least one to one-and-a-half years technology transfer time."

A First-Principles Approach to Cleaning Validation: Rational Acceptance Limits for Biopharmaceutical Process Residues

Rizwan Sharnez, Consultant, and former Scientific Director Amgen
Full Presentation: Wednesday, 13 March 2019 16:00–16:30

In a sneak preview of his presentation, Sharnez talks about the necessary steps to create cleaning validation protocols under strict regulatory guidelines.

He also speaks about industry’s use of single-use equipment. Being disposable in nature, there is no need to have cleaning validation set in place but there are many other validation tasks, risks and costs associated with single-use that he says makes the task of cleaning stainless-steel equipment less onerous than it may seem