Newsletter | June 25, 2026

06.25.26 -- A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis

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Best In Class – Small Molecule API

The CDMO Leadership Awards are based on feedback from biopharma sponsor companies and independently analyzed by Tufts Center for the Study of Drug Development. MilliporeSigma is proud to announce their distinction as 2026’s Best In Class CDMO for Technology Use in the development of Small Molecule API. To learn more about how they can help with your next small molecule development project, click here.

INDUSTRY INSIGHTS

Successful Tech Transfer Meets Commercial Needs

An accelerated technology transfer reduced time to PPQ by over 25%, overcoming novel raw materials, unique IP constraints, and late‑stage process optimization to meet urgent commercial demand.

Challenges In Developing Medical Devices From Animal-Based Biomaterials

Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.

Automated Precision Powder Filling For Annex 1

Aseptic powder filling is complex, demanding automation and isolator‑based, weight‑controlled dosing to ensure sterility and accuracy.

FEATURED EDITORIAL

A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis

This is the first published application of data envelopment analysis to six major pharmaceutical analytical validation guidelines, including ICH Q2(R2), USP, ChP, and Brazil's ANVISA.

Let Your Voice Help Shape Pharma Manufacturing

Pharmaceutical Online hosts live virtual panels with industry experts on important topics and challenges, and we want to know what topics are important to you. Please consider taking a few minutes of your time to tell us what they are.

INDUSTRY INSIGHTS CONTINUED

AI Agents: The Scientists' New Allies

AI agents are reshaping biopharma research, offering new ways to analyze data. Find out how success depends on strong data foundations, governance, and thoughtful adoption strategies.

Ringing The Alarm: Unified Data For GMP Annex 1 Compliance

Alarm monitoring can be more than compliance. Learn how unified data and real-time insights helped one pharma company unlock efficiency, predictive analytics, and a path to digital transformation.

Sterile Injectables: Why Innovation Matters More Than Ever

New technologies and regulatory changes are shaping safer, more efficient filling processes. Discover why innovation is key to protecting patients and advancing therapies.

API Solubility And Dissolution Enhancement Via Formulation

Solubility and dissolution rate of an API are essential for oral drug absorption. See how these factors influence bioavailability, which determines how much and how quickly a drug enters circulation.

Small Molecule Oral Delivery For Rare Diseases: Complexities As A CDMO

Developing therapies for rare diseases faces hurdles like high costs, small patient populations, and complex small-batch manufacturing. CDMOs offer crucial support, expertise, and flexibility.

Real-Time Viable Particle Monitoring: How Does It Work? How Can It Help?

In aseptic manufacturing, laser induced fluorescence shows great potential to replace growth-based methods in certain manufacturing paradigms — highly automated, near-continuous processes.

Zero-Stress Low Volume Aseptic Filling For Solids And Liquids

Aseptic filling technology is of utmost importance. Explore in great detail an aseptic filling solution that has been specifically designed for laboratory and R&D applications in the pharmaceutical industry.

Mold: A Persistent Threat And The Case For Proactive Bio-Decontamination

Examine how a comprehensive investigation and systems-level bio-decontamination strategy successfully eliminated persistent mold contamination in a vaccine manufacturing facility's high-risk area.

Aseptic Blow/Fill/Seal Technology Vs. Traditional Aseptic Processing

Uncover why blow-fill-seal technology has been gaining worldwide acceptance in the parenteral drug marketplace, replacing traditional glass vial processing in a growing number of applications.

Sterile Filtration Of Budesonide As A Preferred Sterilization Strategy

Accelerate development of high‑quality inhalation therapies by leveraging sterile‑filtered budesonide to safeguard purity, stability, and patient safety.

Accelerating Clinical Development: Modern Tools In Process Chemistry

Whether you aim to address bottlenecks or explore advanced techniques, gain a practical and forward-thinking perspective to streamline early-phase development with HTE and model-based approaches.

From Developability Assessment To High-Concentration Formulation

Take a look at a strategic approach to accelerating biologics formulation by gaining early insight into molecular properties and optimizing high-concentration conditions with minimal protein input.

SOLUTIONS

Advanced Digital PCR System

Multimode Microplate Reader

Scalable Solutions For High Potent OSD Manufacturing

Ophthalmic Monoblock Filling Line

Supporting GLP-1 And Peptides With Integrated Solutions

A Connected Digital Workflow That Ensures Consistency

Predictive Platform For Solubility And Bioavailability Enhancement

Compounding Pharmacy Equipment Catalog

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