Newsletter | November 16, 2025

11.16.25 -- Eco-Friendly HBL: Cheaper, Cleaner, And Ready For Pharma

FROM THE EDITOR

Eco-Friendly HBL: Cheaper, Cleaner, And Ready For Pharma

Researchers at the University of Maine may have found a way to do two out of three by developing a new method of producing (S)-3-hydroxy-γ-butyrolactone (HBL) for statins, HIV inhibitors and antibiotics that can lower their production cost with an added benefit of reducing their carbon footprint.

FEATURED EDITORIAL

Trust But Verify: Validating AI In Pharma's GxP World

Here are practical tips to build validated, transparent, and auditable AI systems that align with GxP principles, paving the way for smarter and more resilient manufacturing processes.

Risk-Based Analytical Method Selection In Cleaning Validation Using ASTM International Standards

This in-depth article describes risk in cleaning and provides a science- and risk-based framework for selecting analytical methods using ASTM International standards.

INDUSTRY INSIGHTS

Understanding The Importance Of Powder And Vapor Containment

Optimizing Aseptic Processing With Isolator Technology

Validation In Transition: 2025's Top Trends, Tools, And Takeaways

Formulation Strategies For Enabling "Undevelopable" Compounds

Manufacturing Dry Powder Inhaled Formulations By Spray Drying

5 Steps To Design A Microbiological Performance Qualification For Facilities

Multi-Agitator High-Shear Mixing System Assists In CMC Dispersions

Comparative Analysis Of Batch And Continuous Processes

Adapting To Change – API Custom Development And Manufacturing

Essential Drug Delivery Outputs For Devices To Deliver Drugs, Biologics

The Most Significant Quality Measurement For Manufacturers

Accelerating Novel Therapies To The Market

The Role Of Cleaning In Effective VPHP Decontamination For Isolators

Solutions For Challenging Compounds Using Softgel Innovation

Validation Of A Sterilization Process: Part 2

How To Increase Success In Topical Drug Development With Automation

The Power Of AI And Route Scouting To Navigate API Complexity

Softgel Technology: A Game-Changer For Oncology Treatment

The Case For A Facility Monitoring System

Spray Dried Dispersions In Controlled Release Formulations

Windsor Framework: What Is It?

How To Optimize Labeling In A Pharmaceutical Environment

Implementing A Disaster Recovery Plan

Improve The Performance Of Your Small And Large Molecule Medicines

New Polymer Overcomes Limits In Sustained Drug Delivery In Ophthalmology

The Aqueous Cleaning Handbook

Accelerate And De-Risk Bioconjugate Drug Development

Innovating The mAb Characterization Process

Vaccine Manufacturing: 3 Areas To Evaluate When Selecting A Partner

How CDMOs Can Turn Asset Management Into A Competitive Advantage

The Power Of Biomass Soft Sensors

Evaluating Pyrogen Contamination Risk And MAT In Processing

Next-Generation Digital Technology For Pharma R&D And Manufacturing

U.S. Clinical Labels 101: Steps To Ensure Accuracy

Three Key Actions To Minimize Dead Volumes

Effects Of X-Ray Inspection On Pharmaceutical Products

Development Of RP Methods For The Analysis Of Synthetic Peptides

Match Your Development And Manufacturing Path To Your IND Milestones

Challenges In Ophthalmic Formulations Through Polymer Selection

An Introduction To High Voltage Leak Detection (HVLD) Technology

Building An Effective Contamination Control Strategy For Sterile Filtration

Life Sciences And Automation Companies Deliver The Future—Together

How Intelligent Automation Transforms CQV Workflows

NMR And Mass Spectrometry In Pharmaceutical Development

Peptones And Vaccines: A Synergistic Approach To Enhanced Production

De-Risking FDA Abbreviated New Drug Application (ANDA) Submissions

From First-In-Human To Proof-Of-Concept — Quicker, Smarter, Streamlined

Compliance To Confidence: Annex 1 For Small-Batch, High-Value Production

Inline Buffer Formulation: A Facility Operations Game Changer

A Solvent-Free, Fusion-Based ASD Manufacturing Process

Prioritizing Data Security Through Digital Transformation

Increase Spray Drying Throughput For Brick Dust Compounds

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