Newsletter | October 9, 2025

10.09.25 -- Avoiding Alcohol-Induced Dose Dumping In Oral Drug Formulation

SPONSOR

Looking for an alternative to shark squalene that gives you total peace of mind? Introducing Non Animal Origin Squalene Emprove® Expert – our new fermentation-produced squalene, suitable for high risk applications and use in vaccine adjuvants: excipient GMP according to IPEC-PQG Pharmaceutical Excipients GMP Guide / EXCiPACT® guidelines, ≥ 99.0% purity, low in endotoxins (≤ 2.25EU/mL) and bioburden, specified in the CoA, part of our Emprove® Expert portfolio for high-risk applications. More.

INDUSTRY INSIGHTS

Protecting CAPEX Budgets Through Digital Validation

Streamline your CAPEX validation to accelerate growth, reduce costs, and bring your product to market faster. Discover how futureproof digital validation can protect your budget and maximize value.

Increasing Downstream Process Efficiencies

Downstream processing can account for up to 80% of biopharmaceutical production costs. Optimizing this stage is crucial for resource management, product quality, and overall yield.

Process Re-Design For Sustainability In Small Molecule Manufacturing

Review the optimization of the manufacturing process of a pharmaceutical intermediate, and see how yield can be improved substantially via suitable reaction engineering.

FEATURED EDITORIAL

Avoiding Alcohol-Induced Dose Dumping In Oral Drug Formulation

The FDA has become more vigilant about alcohol-induced dose dumping in extended-release oral dosages. Such dumping can result in anything from reduced therapeutic effects to dangerous toxicity. Let's take a closer look.

INDUSTRY INSIGHTS CONTINUED

Ten Ways To Solve Your Document Review Headaches In Life Sciences

Struggling with document chaos in life sciences? Join James Wilding to uncover smart strategies and tools that streamline reviews, boost compliance, and enhance collaboration.

Rheological Properties Of Pharmaceutical Excipients

Explore lactose monohydrate and CMC rheology, highlighting their flow, cohesion, and compressibility properties to optimize pharmaceutical formulations under varying stress and temperature conditions.

EU GMP-Annex 1: Changes, Challenges, And Ready-To-Use Sterile Packaging

Leveraging a pre-sterilized containment solution that meets the requirements of Annex 1 and outsources non-core activities can help prevent contamination and reduce the effort and liability of the CCS.

Small Molecule API Production: Unveiling The Impact Of Fermentation

Technological developments have led to growth in the suitability of fermentation for a myriad of applications. Gain insight into the impact of the evolution of synthetic biology.

Powering Digital In Pharma

The pharmaceutical industry is undergoing a significant digital shift. Examine the impact of new technologies like AI on everything from drug discovery to manufacturing processes.

The Future Of MES Is Composability

Learn about a no-code, cutting-edge MES that transforms modern manufacturing and has unique advantages, which are essential for streamlining operations and boosting efficiency.

Media And Buffer Mixing Using A Magnetic Mixer

A common requirement for media and buffer preparation in biopharma processing is powder-liquid mixing. Review the performance of a 3000 L single-use mixing system for preparing aqueous solutions.

End-To-End Development: Small Volume Commercial Products

To meet ambitious orphan drug development timelines, CDMOs must be able to scale quickly to progress from early clinical development to validation and commercial launch.

Building The Next Therapeutic Modality With End-To-End Product Support

Extracellular vesicles hold immense potential for treating diseases, owing to their natural biocompatibility and ability to carry a diverse arsenal of therapeutic molecules.

SPONSOR

Webinar: How to Address Your Solid Dosage Processing Needs?

This webinar helps manufacturers align product needs with processing strategies and equipment choices. Participants will learn to evaluate requirements, select techniques for quality and consistency, and monitor processes effectively. By the end, attendees will gain practical tools to ensure uniform, reliable, and compliant products. Key takeaways include understanding processing needs, monitoring effectively, and achieving consistency. Click here to learn more.

SOLUTIONS

Solvent-Free, Fusion-Based Amorphic Dispersion Process

Liquid Fill-Finish Platform

Biodegradable Polyester Amide Platform For Sustained Delivery Solutions

GLP-1 Receptor Agonist Solutions

Capacity Update: Small Molecule Drug Product/Finished Dosage Form

High Voltage Leak Detection Systems For Glass Vials

Connect With Pharmaceutical Online: