Newsletter | November 21, 2025

11.21.25 -- STREAM Edition: Developing Analytical Methods For Advanced ADCs

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Webinar: Unlock Productivity in mAb Production: Upstream and Downstream Intensification

Discover how Thermo Fisher Scientific is transforming monoclonal antibody (mAb) production through next-generation process intensification technologies. This webinar highlights innovative upstream and downstream strategies—from high-density cell banking and optimized CHO-K1 media to single-use systems and in-line dilution technologies—designed to streamline workflows, reduce costs, and significantly enhance efficiency across every stage of modern mAb manufacturing. Click here to learn more.

Uncover The Intricacies Of Transposase-Mediated Genome Engineering

Webinar | ATUM

In this presentation, experts provide insight into transposase-mediated genome engineering, genetic quality control, and the maintenance of genetic stability in cell line generation.

Epic Bio's Clinical Approach And Springbok Analytics Partnership

Video | Bioprocess Online

Epicrispr Biotechnologies' Amber Salzman discusses the company's lead candidate, EPI-321, which is being developed to treat Facio-scapulo-humeral muscular dystrophy (FSHD). To accurately measure the drug's effectiveness, the company has partnered with Springbok Analytics, which uses AI to analyze MRI muscle imaging.

EU Regulations: Ensuring Compliance For Integral Combination Products

Webinar | West Pharmaceutical Services, Inc.

Review the EU Medical Device Regulation (MDR) changes, specifically with respect to integral combination products, and examine the technical documentation packages supporting functionality and content.

A Standardized Playbook For Gene Therapy Manufacturing

Video | Thermo Fisher Scientific Bioproduction

In this segment, Dr. Peter Marks shares developments in CMC for advanced therapies in the near future.

 

Addressing Hepatitis Delta With Mark Eisner, MD

Video | Bioprocess Online

Hepatitis delta is a severe and rapidly progressing liver disease that presents a significant challenge. Dr. Mark Eisner of Vir Biotechnology discusses the promising combination regimen of tobevibart and elebsiran, which is poised to enter a Phase 3 trial. Researchers anticipate this regimen can achieve complete viral suppression in the majority of patients, offering hope for those affected.

Developing Analytical Methods For Advanced ADCs

Video | Bioprocess Online

Advanced molecules, especially ADCs with novel constructs, require extensive characterization testing. In this segment from the Bioprocess Online Live event “Evolving CMC Strategies To Enable Next-Gen ADCs,” panelists discuss the nuances of analytical methodology for advanced ADCs and emphasize the importance of potency assays. They also share their thoughts on how much CMC development companies should aim to do internally before working with development partners.