Collaborative Bioprocessing: Next-Gen mAb Downstream Manufacturing Enhanced by Transcenta Partnership

The bioprocessing industry has identified an urgent need to intensify downstream operations, making them smaller, faster, and more cost-effective. While numerous technologies and techniques exist to intensify individual unit operations, implementing an integrated next-generation bioprocess presents significant challenges. Our collaboration with Transcenta has culminated in the development of a state-of-the-art, highly automated bioprocessing train for the manufacture of monoclonal antibodies and other biologics.

This webinar will detail the bioprocessing template, operational paradigm, and the complexities involved in qualifying such an advanced manufacturing method.

In this webinar, you will learn:

• What constitutes an intensified bioprocess,
• Transcenta's template for next-generation bioprocess capability,
• The installation and qualification of a multi-column chromatography system and a flow-through polishing system,
• Strategies for managing and qualifying long-duration bioprocessing challenges, such as bioburden control.

An on-demand version of this webinar will be available after the live event using the same link. Register now and access the webinar at your convenience.

Presenter: Jerome Dalin (Associate Director – Alliance Management, BioContinuum™ Business Franchise)

Jerome Dalin holds an MSc/Engineering degree in Industrial Manufacturing and Biological Engineering. He began his career at Sanofi Pasteur 21 years ago, focusing on vaccine process development in France, Canada & USA. In 2013, Jerome joined our company to manage bioprocessing sales and later transitioned to the Strategy organization to lead global initiatives for vaccines and the Factory of the Future. In his current role, Jerome is at the helm of Alliance Management, driving the development of the BioContinuum™ platform across the biopharmaceutical industry.

Presenter: Kara Pizzelli (Downstream Process Strategic Product Manager, Biocontinuum™ Business Franchise)

Kara Pizzelli holds a MSc degree in Chemical Engineering. Her career started at our company 25 years ago focusing on the optimization and scale-up of the unit operations from Clarification to Bulk Drug Filtration for customers in the US. Kara more recently managed the global Clarification business, owning the strategy and innovation, before taking on the role of DSP Strategic Product Manager in the Biocontinuum™ Business Franchise in 2023.

Presenter: Chris Hwang (EVP, CTO, Transcenta)

Chris Hwang holds a Ph.D. in Biochemical Engineering from MIT and has over 30 years of experience in the biopharmaceutical industry. He began his career at Genzyme and later at Sanofi, supporting and leading CMC development as well as process and technology development. He also served as project lead for the Integrated Continuous Biomanufacturing platform program. Chris joined HJB/Transcenta in 2016, where he is responsible for CMC development and developing and industrializing highly intensified biomanufacturing platforms to increase facility output, enhance process control, and reduce the cost of goods to expand patient access to innovative biologics.

Presenter: Jewell Zhou (Lead Scientist – CMC Process Development, Downstream Platform, Transcenta)

Jewell Zhou holds a Msc/Engineer degree in Biology and Bioprocessing Engineering. He joined the HJB company in 2018 as a scientist to develop downstream purification process for CMC. Since 2020, he joined the HJB HiCB group and started to build and support continuous purification platform for advanced antibody manufacturing. In his current role, Jewell is working on HICB/Transcenta platform development and supporting continuous manufacturing control strategy.

Presenter: Dr. Paul Beckett (Senior Strategic Product Manager – Clarification and Chromatography GTM Lead)

Paul holds a bachelor’s degree in biochemistry from Imperial College London and has a master’s degree and doctorate in biochemical engineering from University College London. Paul has worked in the pharmaceutical industry for 20 years and has held a number of roles in this capacity, including managing bioprocesses for early phase clinical material, CMC regulatory affairs consultancy and programme management of the next generation bioprocessing initiative. His current role is the global GTM lead for the chromatography and clarification technologies at our company.