Newsletter | September 25, 2025

09.25.25 -- What Biotech Sponsors Should Look For In A CDMO For Sterile Fill/Finish

SPONSOR

Webinar: Driving Operator Safety and Process Efficiency Through Innovative Prep and Column Changeover

Join Asahi Kasei Bioprocess for a webinar on transforming pharmaceutical production. Discover how safety and efficiency can be strategic levers for long-term success through smarter prep and column changeover workflows. Explore innovative solutions—THESYS® ACS Ergo, CURSIV® DAC Ergo, and SLURIPREP®—that simplify processes, reduce risk, and empower operators with ergonomic, human-centered design for greater productivity. Click here to learn more.

FOCUS ON OUTSOURCING

What Biotech Sponsors Should Look For In A CDMO For Sterile Fill/Finish

Choosing the right CDMO partner for a biotech product isn’t about “capacity at a good price”; it’s about a partner with the right mix of technical expertise, regulatory track record, and more.

mRNA Immunogenicity: Early Assessment Of Human Immune Response

Review strategies to assess the potential for human immune response following the administration of an mRNA therapeutic, the associated LNP, and the protein encoded for by the mRNA.

BsAb Development With Structural Innovation, Enhanced Manufacturability

Bispecific antibodies (bsAbs) offer transformative therapeutic potential through dual-target engagement, but their complex structure presents significant manufacturing challenges.

3 Keys To Rare Disease Clinical, Commercial Drug Product Manufacturing

The complex biology of rare diseases creates unique hurdles, making it difficult to design and implement a drug development program. Explore the unique considerations for drug product manufacturing.

A Guide To The Cell Line Development Journey

A principal concern of cell line determination is producing the desired protein in a considerable quantity. Understand the technical and regulatory considerations for microbial, mammalian, and yeast platforms.

Engineering E. Coli For Novel Biopharmaceutical Manufacturing

Recent advancements in genetic engineering and analytical techniques have significantly enhanced E. coli's potential for protein expression.

Evaluating Formulation's Effect On The Uptake Of Recombinant Antigen

Learn how an in vitro method for evaluating how different vaccine formulations affect antigen uptake by human dendritic cells can help advance the rational design of new subunit vaccines.

Inclusion Bodies: Mother Nature's Help Or Hindrance?

Explore strategies to improve the performance of IB processes as well as the pros and cons of soluble and insoluble processes: isolating, solubilizing, and properly refolding.

SPONSOR

Join Bioprocess Online Live on October 7 at 11am ET for an interactive discussion on evolving CMC strategies for ADCs with leading experts in the space. This Q&A will feature CrossBridge Bio’s CEO and co-founder, Michael Torres, Ph.D., and acting CTO, Morris Rosenberg, Ph.D., as well as Borys Shor, Ph.D., an advisor to OS Therapies and director at Manhattan BioSolutions. Registration is free for this digital event thanks to Cytiva.

OUTSOURCING SOLUTIONS

Capacity Update July 2025: Large Molecule Drug Substance - FUJIFILM Biotechnologies

Analytical Method Development For Biologics & Bioconjugates - Abzena

European Center Of Excellence For Clinical Biologics - Catalent

Combining Scientific Knowledge And Advanced Technology - Mabion

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