Newsletter | September 16, 2025

09.16.25 -- EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance

SPONSOR

Advancing the Future of Cell & Gene Therapy

This 11-12 November, Cell 2025 unites 1,000+ experts across the CGT value chain to solve key challenges, from scalable bioprocessing and regulatory hurdles to accelerating development. Gain insights across cell culture, therapy development, and CGT manufacturing, and learn from world-renowned leaders Bobby Gaspar (Orchard Therapeutics), Christof Von Kalle, (Research Clinic Luxemburg), and Dame Molly Stevens (University of Oxford). Register Now

INDUSTRY INSIGHTS

A Complete Guide To Capsule Checkweighing

Understand why accurate capsule weighing is essential for therapeutic efficacy, safety, and adherence to pharmaceutical manufacturing standards.

Key Metrics In Antibody Drug Development

Explore key techniques like DSC and Rheology to assess thermal stability and viscosity in antibody drug development. Gain practical insights to enhance biologic candidate selection, formulation, and delivery.

FEATURED EDITORIAL

EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance

The EMA issued three new draft documents in July, all related to the advancement of the use of electronic technology in GMP: AI, computerized systems, and documentation. The public comment period ends Oct. 25.

INDUSTRY INSIGHTS CONTINUED

How Process Intensification Supports A Sustainable Future

Discover how process intensification is revolutionizing bioprocessing by boosting efficiency and reducing waste. Hear from experts on how these innovations are driving a more sustainable future.

4 Reasons For The Rise In Blister Packaging

Here are the factors that are driving blister to the forefront of pharmaceutical packaging, and at an even faster rate than its current growth.

Progress In LC-MS-Based Metabolomics Techniques

Get updated on recent and current advances in metabolome analysis by mass spectrometry with this introduction to the different approaches and technologies.

A Case Study Of The GLP-1 Receptor Agonist, Semaglutide, In Plasma

Light scattering reveals critical insights into the structural integrity, aggregation, and stability of GLP-1 analogs, which are essential for optimizing drug formulations and improving treatments.

Designing Shelf-Stable, Dry Powder Vaccines To Improve Global Access

Spray dry technology is being leveraged to create shelf-stable, dry-powder vaccines to treat and prevent the spread of tuberculosis which could significantly improve our global response to disease.

Real-Time Viable Particle Detection For Definitive Root Cause Investigation

Investigations into viable air excursions are difficult to perform using traditional methods. Read why a real-time viable particle counter is key to providing process improvement.

Corporate Social Responsibility In Equipment Purchasing And Management

Learn how pharmaceutical companies can reduce waste, cut emissions, and improve financial performance by prioritizing equipment reuse and optimizing asset management.

Overcome Global Medicine Shortages With Innovative Manufacturing

Looking to improve the resilience of your supply chain? Who isn’t? According to a report by Bain & Company, improving supply chain resilience will require redundancy, adaptability, and predictability.

Overcoming Melt Processing Challenges

Find out how a biodegradable polymer platform, easily applied with hot melt processing, enables processing at a relatively low temperature while preserving the potency of temperature-sensitive APIs.

Design Testing Strategies To Develop A Drug-Device Combination Product

Leveraging the expertise and experience of a trusted partner can reduce risk and accelerate the time to market for drug-device combination products by creating an optimal Validation Master Plan.

SOLUTIONS

Customized CMC Solutions

A New Standard In Virus Filtration For Enhanced Efficiency

Your Partner For Biocatalysis Solutions

Service Solutions Designed To Help You Gain Speed To Clinic And Market

Clinical Pharmacology Services

Enterprise Asset Management Platform

Solid Form Services

Connect With Pharmaceutical Online: