API Biopharmaceutical Contract Manufacturing / Biomanufacturing Services

Representative Environmental Monitoring: Why Monitoring Activities Are Not Interchangeable Within a Contamination Control Strategy
Thursday, October 29, 2026
Environmental monitoring activities should not be assumed to be interchangeable because contamination control questions are not interchangeable. Different contamination control questions require different information. Environmental monitoring exists to generate that information. read more
The Importance of a Hybrid Testing Approach for Safety Assessments in the NAM-Enabled Era
Thursday, October 29, 2026
For decades, in vivo models have been the standard in preclinical testing before a drug moves to first-in-human (FIH) trials. But a recent evolution in regulatory expectations has accelerated a steady shift away from in vivo testing, in favor of New Approach Methodologies (NAMs). read more
The Evolving Regulatory Landscape for Cell and Gene Therapies
Thursday, October 29, 2026
The regulatory landscape for CGTs is moving towards more explicit, risk-based assessment of intended editing outcomes, off-target activity, and genomic integrity. This evolution reflects both the promise of new editing technologies and the need to understand their potential consequences in ... read more
Building Resilient Pharma Supply Chains to Strengthen Patient Healthcare
Thursday, October 29, 2026
Continuity of care is generally defined in terms of a patient’s ongoing contact with a clinical team and how smoothly their care progresses between providers. Often overlooked is the pharma supply chain and its role in ensuring this continuity. read more
The Tough Decisions
Thursday, October 29, 2026
While there are many drugs to make the end of life easier and less painful, the fundamental problem of deciding when to end life is a topic and a decision few want to address. read more

More News

A Solid Dosage Future
In the pharmaceutical manufacturing space, while biopharmaceuticals often dominate discussions, it's crucial to acknowledge the enduring significance of solid dosage products (e.g., tablets, capsules, pills). These traditional forms remain the ...
Pharma Flash - Layoffs and Mergers & Acquisitions - Plus Long COVID Study ...
Check out the top pharma news of the week from our Editor-In-Chief, Mike Auerbach. Watch video: In this week’s Pharma Flash – Emergent cuts business operations and reduces headcount. PrecisionLife releases COVID study results and Lilly and Regeneron...