Newsletter | August 27, 2026

08.27.26 -- Lower Court Agrees With WuXi AppTec (And Many Of Us)

SPONSOR

Webinar: When Biologics Supply Can’t Fail: How Sponsors Should Evaluate Manufacturing Resilience

Biologics supply resilience is now a critical factor in successful outsourcing decisions. Join this Boehringer Ingelheim webinar to learn how to evaluate CDMO partners beyond capacity, assessing manufacturing readiness, quality systems, technical expertise and business continuity strategies. Gain practical guidance to reduce supply risk, strengthen long-term program success and confidently select partners that support reliable biologics manufacturing. Click here to learn more.

INDUSTRY INSIGHTS

Increasing Success Rates In Your Drug Discovery Research

Learn about a reputable, highly diverse screening library and fragment collection that could pave your way through a successful discovery campaign.

Leveraging Bio-Functional Assays For Charged Variants Characterization

The heterogeneity of a biologic product has implications for the final therapy's safety and efficacy. Explore challenges associated with charged variants, including mAbs and fusion proteins.

Shaping The Next Era Of Biologics Manufacturing In North Carolina

North Carolina is a leading U.S. biopharma manufacturing hub, driven by our investment in a scalable, talent-rich, resilient, and integrated network.

FEATURED EDITORIAL

Lower Court Agrees With WuXi AppTec (And Many Of Us)

A lower-court ruling does not make a victory. But it adds a little sanity to this melodrama. On August 7, a U.S. District Judge did something that has been surprisingly rare in the long-running WuXi AppTec/BIOSECURE Act saga: He looked at the U.S. government's case for labeling WuXi a “Chinese military company” and decided the government had not shown enough evidence. Analysis from Chief Editor Louis Garguilo.

CSV Assumes The AI System Sits Still — It Doesn't.

The computer system validation playbook was written for software that holds its shape. AI doesn't. Validating it has to become an act of governance.

INDUSTRY INSIGHTS CONTINUED

Soluble Versus Insoluble Expression In Microbial Fermentation

Expression of inclusion bodies has historically suffered a bad reputation in the industry. So, how do these two routes, soluble and insoluble, compare in terms of their advantages and challenges?

Integrated Analytical Development For Biosimilar Comparability Studies

Discover integrated analytical development for biosimilars, supporting characterization, comparability, validation, and regulatory submissions through co-located expertise and experience.

De-Risking A Novel Valve Component For Use With Standard Syringe Systems

A novel valve provides dual‑chamber functionality within standard syringes, keeping two liquid drugs separated until injection while reducing development risk through advanced modeling.

How Confident Are You In Your Autoinjector?

As demand for self-administered therapies accelerates, autoinjectors, formally known as automated needle-based injection systems (NIS-AUTO), are playing a central role in modern medicine. 

Periodic Counter Current Chromatography: A Step Toward Continuous DSP

PCC boosts Protein A capture efficiency, cuts resin costs, increases productivity, and enables continuous downstream processing without sacrificing quality or compliance.

Doubling Up For Speed In Biomanufacturing

Accelerate drug development and reduce risk with parallel operations. Assimilate how leveraging CDMO partnerships while building internal capabilities can cut costs and speed your path to market.

Driving Rapid Development Of Complex Biologics

To meet mAb, bispecific, and multispecific expression needs, sponsors require a proven cell line platform that delivers high‑titer, stable expression for complex proteins.

Accelerating Bulk Harvest Release Testing With A PCR-Based Solution

Adventitious agent testing is frequently a bottleneck in downstream processing. Uncover a PCR-based solution for manufacturing processes using CHO cells and animal origin-free components.

SOLUTIONS

Partnering For Analytical Excellence

Protein Expression And Analysis

Sterile Injectable End-To-End CDMO Services

Integrated Quality, Regulatory, And Safety Services

GS Effex® Cell Line For Enhanced Antibody Effector Function

OUTSOURCED PHARMA CAPABILITIES UPDATE

Find Your New CDMO At Outsourced Pharma Capabilities Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capabilities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

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