Newsletter | April 21, 2026

04.21.26 -- What If The U.S. Government Stopped Funding Biotech?

SPONSOR

Webinar: Strategic Early Material Generation for Accelerated Process Development

Accelerating access to early-stage material is critical for efficient biologics development. In this webinar, Samsung Biologics shares its integrated approach to early material generation, aligning with cell line development to deliver scalable, production-relevant material faster. Learn how this strategy supports developability assessment, reduces variability, and enables efficient downstream activities, with case studies demonstrating improved timelines, resource use, and overall program success. Click here to learn more.

FOCUS ON OUTSOURCING

What If The U.S. Government Stopped Funding Biotech?

It sets off a real tension – ideological, economic, even personal. But what would happen if the U.S. government cut direct financial support for “biotechnology research,” leaving it entirely to investors, private and public markets, and bigger pharma? "Our industry’s mind-meld says with no government largesse our biotech industry collapses," writes Chief Editor Louis Garguilo. It's an "outlandish hypothetical," but he asks for a few minutes to go through this. And he has help in making his case.

Validation Provider Shortens The Path To Equipment Qualification

Explore the partnership enabling Transcat to meet regulatory requirements while focusing on core R&D and accelerating the delivery of life-changing therapies.

Driving Robust Tech Transfer: Computational Fluid Dynamics Simulation

Computational Fluid Dynamics simulation is essential for robust biologics tech transfer. See how this predictive tool optimizes critical scale-up processes, reducing risk and expediting time to market.

Managing Supply For Complex Biotherapeutics

Antibody-drug conjugates' manufacturing supply chain contains five different technologies with specific asset needs: monoclonal antibody, cytotoxic payload, linker, bioconjugation, and fill & finish.

Flexibility In Development: From Tactical Response To Strategic Imperative

Build flexibility into your drug development strategy to navigate change effectively, maintain momentum, and drive successful outcomes across every stage of the lifecycle.

Getting Your Proof Of Clonality Right For Regulators

Regulators require clear, verifiable proof that production cell lines originate from a single progenitor cell, supported by strong imaging, documentation, and data integrity to ensure product consistency and safety.

Controlled Nucleation Offers Homogeneity And Batch Consistency

Controlled nucleation standardizes freezing across all vials, leading to uniform ice crystals and improved lyo cake quality. This critical step reduces variability and supports robust product scale-up.

Optimize Your CLD With Innovative And Flexible Transposase Technology

To ensure speed and stability in the manufacture of your complex biologic — mAbs, antibodies, fusion proteins, and/or antibody drug conjugates — prioritize a high-performance CLD workflow.

Leveraging Platforms To Create Vaccines At Pandemic Speed

Learn about the University of Queensland's rapid development of a vaccine candidate for COVID-19 and the role GS Xceed® system played in this project.

Device Design For Usability And Risk Reduction

Growing use of large‑volume subcutaneous therapies is increasing demand for wearable injectors that reduce user error, simplify preparation, and enhance safety through human‑factors‑focused design.

Empowering The Future Of Medicine

Accelerate from development to commercialization with scalable manufacturing solutions. Integrated digital systems and expert technical advocacy ensure regulatory excellence and rapid batch release.

SPONSOR

Join Bioprocess Online’s Tyler Menichiello on April 28 at 11 AM ET for an interactive panel discussion examining how regulatory lag, evolving biocompatibility standards, and the complexity of converting legacy systems slow the uptake of innovative single-use materials in biomanufacturing. Registration is free thanks to event sponsor Cytiva.

OUTSOURCING SOLUTIONS

Product Development - August Bioservices

Meet The Demands Of Today To Help Ensure The Possibility Of Tomorrow - Kindeva

Rapid Antibody Gene-To-Drug Substance - Catalent

Viral Clearance Testing For Biologics, Vaccines, And AAV Therapies - Minaris

Streamlining CRISPR-Cas9 Gene Editing - ElevateBio

Accelerate Your Program With A Flexible Partner - KBI Biopharma

Path To IND For Biologics Delivers Phase 1 Material In 9 Months - Thermo Fisher Scientific

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