Newsletter | March 19, 2026

03.19.26 -- Advising The Biotech C-Suite To Reconsider Quality

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Regulators are shifting the biosimilar approval paradigm — prioritizing deep process understanding over large clinical trials. In this evolving landscape, defining and controlling CPPs is essential to demonstrating high similarity. Join Bioprocess Online’s Jon O’Connell on March 24th at 11 am Eastern for a live Q&A with Sarfaraz Niazi, Ph.D., Vince Narbut, and Diana Colleluori, Ph.D., as they explore how QbD and CQA insight can streamline development and regulatory success.. Register for free today thanks to support from sponsor Cytiva.

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Advising The Biotech C-Suite To Reconsider Quality

“I assist C-suite executives to transfer quality from a painful cost center to a competitive asset." It's the type of bold statement that draws one's attention. Chief Editor Louis Garguilo asked David Grote on what his assertion means materially – and how that’s applied to working with CDMOs. Here's their discussion that focuses on a transformation that moves executives from regarding quality as ‘overhead’ to recognizing quality as “an operational element for business advantage.”

Balancing The Scales: The Ups And Downs Of Bioprocess Scale-Up

Delve into the complexities of scaling decisions to gain insights from biopharma developers and a CDMO. Learn about their mutual interest in achieving successful scale-up and strategies.

Flexibility Or Scale? Navigating The Single Use Vs. Stainless Steel Debate

Explore how to choose between single‑use and stainless‑steel bioreactors, outlining key advantages, limitations, and long‑term considerations essential for successful biologics scale‑up.

How Strong Intellectual Property Laws Keep Health Innovation Humming

Strong IP protections drive Tennessee’s biotech growth by attracting investment, supporting research, fostering collaboration, and enabling innovators to deliver new therapies and technologies to patients.

Friendshoring: A Strategic Shift In Pharma Supply Chains

To safeguard the consistent delivery of essential therapies to patients around the world, biopharmaceutical companies, alongside their CDMO partners, are rethinking traditional supply models.

Accelerating Rare Disease Treatments From Concept To Cure

Access a thorough investigation that delves into the critical aspects of expediting curative therapies, with a focus on the strategic role that CDMOs can play in this transformative journey.

How To Choose The Right CDMO Partner For Fill & Finish

CDMO selection requires evaluating experience, quality standards, and flexibility. Assess technical transfer skills, supply chain security, and collaborative approach for a reliable, long-term project fit.

The Advantages Of Off-The-Shelf GMP iPSCs With A DMF

Learn how off-the-shelf, GMP-grade iPSC lines with a Drug Master File (DMF) can accelerate cell therapy development, streamline regulatory approval, and reduce time and cost to clinic.

Simulated Control Strategy For Product Diversion Management

Consider this manufacturing platform integrating perfusion bioreactors, continuous product capture, low pH viral inactivation, polishing, viral filtration, and formulation steps.

Using Plant Peptones To Boost Plasmid Yield And Induction

Uncover how Nu‑Tek’s plant-based peptones support E. coli growth, plasmid yield, and controlled induction, offering a sustainable, animal-free alternative for biopharmaceutical cell culture.

How Does A CMO Define Legacies?

Partner with a CMO that combines expertise, innovation, and trusted global capabilities to bring life-changing therapies to patients faster and more reliably.

Early Development To Clinic – De-Risking A Bioconjugate's Journey

The journey of a novel bioconjugate into clinic is complex and uncertain. Examine the particular challenges when moving a bioconjugate candidate from early development into clinic.

OUTSOURCING SOLUTIONS

Trusted End-To-End CDMO Partner For Your Journey - Samsung Biologics

From Sequence To Clinic: Faster Decisions Through In Silico Insights - Coriolis Pharma

Your Partner In Mammalian Cell Cultures - Boehringer Ingelheim Biopharmaceuticals GmbH

An Efficient Site-Specific Conjugation Technology - Abzena

Made For What's Next In Drug Delivery - BD Medical - Pharmaceutical Systems

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