Newsletter | July 3, 2026

07.03.26 -- Achieving Annex 1 Compliance In Sterile Manufacturing, Part 1: Common Compliance Failures

INDUSTRY INSIGHTS

How Equipment Choices Influence Scientific Velocity In Development

As drug modalities grow more complex, speed depends on smarter decisions. See how bioprocessing equipment choices play a larger role in enabling momentum than many teams realize.

Meet Regulation Requirements With RTU Vials And Cartridges

Sterile manufacturing remains vital, with resilient supply chains preventing shortages. Industry and regulators prioritize integrity as demand surges, making it the fastest-growing pharmaceutical segment.

Softgel Formulation Strategies For Challenging Oral Compounds

Explore strategies to solve solubility and permeability challenges, boost oral bioavailability, and ensure consistent absorption — reducing risk and unlocking complex molecules.

FEATURED EDITORIAL

Achieving Annex 1 Compliance In Sterile Manufacturing, Part 1: Common Compliance Failures

A persistent gap remains between what Annex 1 requires and what facilities can demonstrate. Let's take a closer look at four common compliance failures.

INDUSTRY INSIGHTS CONTINUED

Advancing Drug Safety And Improving R&D Productivity With A Liver-Chip

Gain insight into how an innovative Liver-Chip S1 revolutionizes predictive toxicology by mimicking human liver biology, achieving superior sensitivity and specificity.

Accelerating Discovery Success With Structure-Guided Drug Design

Structure‑enabled drug discovery revealed a novel, druggable binding site in Artemis, enabling rapid SAR optimization and a ~500‑fold potency improvement against a challenging oncology target.

Polymorphism 101: What Drug Developers Need To Know To Reduce Risk

Polymorphism impacts solubility, stability, and manufacturability, making early solid‑form screening critical to reduce risk, guide development decisions, and ensure consistent performance.

Evaluating Carryover When Using A TOC Analyzer

Accurate TOC results shouldn’t depend on sample order. Discover how low-level measurements remain reliable even after high-TOC analysis, helping reduce false positives and streamline decisions.

Overcoming The Data Hurdle: Defining 'Good Data' For Agentic AI

Agentic AI delivers real value only when supported by contextualized data. Examine how unified data fabrics transform siloed records into actionable intelligence, enabling faster, more reliable decisions.

Maximum Quality Control

Precision inspection and compliance-driven processes are essential for manufacturing to help safeguard product quality, support regulatory requirements, and protect patient safety at scale.

SOLUTIONS

Our Spokane Foreign Trade Zone (FTZ)

Multiparticulates For Modified Release Systems

The Future Of QC Is Now

Sterile Fill/Finish Capability

Reduce Production Waste In Pharmaceutical Manufacturing

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