Newsletter | May 29, 2026

05.29.26 -- Why Isolators Do Not Automatically Ensure Annex 1 Compliance

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Webinar: The Column and the Crystal: Purification Strategies for Small Molecule APIs

Join this 2-part MilliporeSigma webinar series to discover how CDMOs overcome some of the toughest small molecule development challenges. Explore advanced crystallization strategies, digital chromatography tools, and innovative techniques like fraction mapping that improve purity, filtration, and scalability. Featuring real-world case studies, this series highlights how specialized expertise and approaches can transform difficult-to-handle molecules into commercially viable processes. Click here to learn more.

INDUSTRY INSIGHTS

How High Drug Load Nanocrystalline Tablets Lower Pill Burden

We showcase the development of high drug load nanocrystal based tablets and prove that nanocrystals can match the pharmacokinetic performance of ASDs while reducing the overall pill burden.

Selection Criteria For Ribbon, Vertical, Or Tumble Blenders

Aside from the level of shear or ‘gentleness,’ a number of other factors help determine which type of blender will work best in certain applications. Explore considerations for blender selections.

3D Screen Printing: Breakthrough Solutions For Patient-Centric Therapies

Discover 3D screen printing’s potential to revolutionize pharmaceutical manufacturing with scalable, customizable, multi-drug tablets and precise, patient-centric drug release profiles.

FEATURED EDITORIAL

Why Isolators Do Not Automatically Ensure Annex 1 Compliance

Isolators are powerful tools, but they do not automatically ensure compliance with EU GMP Annex 1. RABS are frequently dismissed too quickly. The difference is not the technology itself, but how it is applied.

INDUSTRY INSIGHTS CONTINUED

Improving Uptime In Aseptic Processing Of Pharmaceutical Liquids

Maximized uptime, minimized changeover time, and efficient OEE are key factors that have influenced the acceptance of aseptic blow-fill-seal in the packaging of pharmaceutical liquids.

Restarting A Manufacturing Campus And Revitalizing A Community

A high‑risk facility acquisition in Huntsville became a blueprint for revitalizing a modern pharmaceutical campus. See how coordinated action turned a massive shutdown into a renewed manufacturing hub.

Why Is It Important To Have Properly Trained Visual Inspectors?

Properly trained visual inspectors are crucial for identifying defects in parenteral drugs, safeguarding patient safety and product quality.

A Strategically Positioned, Globally Credible CDMO Partner

Strategic location, strong regulatory oversight, institutional stability, and deep expertise reduce risk, speed approvals, and enable reliable, long-term pharmaceutical development partnerships.

Scaling Manufacturing Flexibility For Fill-Finish Commercial Success

Pharma and biotech developers rely on adaptable fill‑finish capacity to meet evolving market demands, scale products from clinical to commercial, and respond rapidly to public‑health emergencies.

A Holistic Approach To CCI Is A Deterministic Approach

A modern approach to CCI blends smart design, risk‑based strategies, and deterministic testing to safeguard sterile products. Learn how lifecycle thinking and practical sampling plans strengthen quality.

The Impact Of A Unified Culture, From CDMO To Client To Patient

Operational excellence in drug manufacturing relies on a unified culture of integrity and proactive problem-solving. Aligned global teams strengthen the supply chain for reliable patient treatments.

Adapting With Automation: A Guide For The Modern Lab

Modern microbiology laboratories are starting to look different from the laboratories of 10 years ago. The work will be similar, yet technology will be advanced. Automation, in particular, is taking center stage.

Antibody-Drug Conjugates – Catalysts For Chemistry

Review the complexities of developing linkers – chemical moieties which attach a drug payload to an antibody – and considerations when identifying a CRO for ADC research and development.

Rapid Development Of Amorphous Solid Dispersions For Bioavailability

Find out how an amorphous solid dispersion (ASD) of acalabrutinib was designed using in vitro studies and in silico modeling. Understand how ASD formulations can enhance bioavailability.

BsAb Development With Structural Innovation, Enhanced Manufacturability

Bispecific antibodies (bsAbs) offer transformative therapeutic potential through dual-target engagement, but their complex structure presents significant manufacturing challenges.

Cloud Migration In Regulated Environments: Best Practices

Cloud adoption is essential for BioPharma growth, offering scalable tools for faster research. Success requires a risk-based approach to ensure data integrity and GxP compliance during the shift.

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Organoid-Based Drug Screening Services

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