Newsletter | August 26, 2026

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

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INDUSTRY INSIGHTS

What Everyone Needs To Know About Polymorphs

Build a strong foundation in solid form science — especially polymorphism — to reduce risk, control variability, and accelerate your path from development to reliable, cost-effective manufacturing.

Complex Molecules, Complex Problems

The support of an experienced CDMO is critical to overcoming complexity when working with highly potent APIs and when solving solubility challenges.

Formulation & Delivery Of Spray Dried Biologics For Nasal Dosage Forms

Spray drying enables stable, scalable dry‑powder nasal biologics, improving shelf life, particle control, and targeted delivery for peptides, proteins, vaccines, and oligonucleotides.

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.

July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing

Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.

INDUSTRY INSIGHTS CONTINUED

Addressing Regulatory Challenges For Ophthalmic Combination Products

Classifying eye drops as combination products complicates approval. Learn how identifying the primary mode of action early and aligning dual quality frameworks prevents costly launch delays.

Safely Scaling High Potency API Manufacturing

Scaling HPAPI production demands disciplined containment and exposure control. Integrated operating models help manage risk while enabling compliant, reliable scale‑up.

Re-Thinking ASD Development: When Your Molecule Breaks The Rules

A solvent‑free, fusion‑based approach streamlines amorphous solid dispersion development, enabling rapid early screening, improved performance, and sustainable manufacturing.

Assessing Developability And Designing Advanceable Formulations

Discover how early developability assessments and a quality-by-design approach can streamline formulation, reduce risk, and accelerate your path to successful, cost-effective drug development.

Navigating Downstream Processing (DSP)

DSP failures kill commercialization timelines. Learn how integrated harvest, filtration, and purification infrastructure protects product stability at scale.

Operational Readiness Frameworks For Pharma And Biotech

Achieving top performance in life sciences requires a continuous journey from Operational Readiness (OR) to sustained Operational Excellence (OE), ensuring safe startup and long-term efficiency.

SOLUTIONS

Product Development Services (PDS) For Steriles

State-Of-The-Art Drug Product Manufacturing Capabilities

Accelerate NCE Discovery With India-Based Medicinal Chemistry Expertise

Process Development

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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