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The EU Overhauls Pharma Laws: What You Need To Know

On Sept. 18, the Council of the EU published the almost-final text of a major overhaul of the EU pharmaceutical laws. The final binding text is expected to be published very soon.

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EDITOR'S DESK

On The Ground At BPI: Jacqualyn Schulman, Ph.D., On Accelerating Clonal CLD
An interview with Jacqualyn Schulman, Ph.D., a principal scientist at Bristol Myers Squibb (BMS), on her presentation at BPI 2026, “Fast-Tracking CHO Cell Line Development Using Integrated Engineering Strategies.”

AstraZeneca's Focus On Predictive Control, Semi-Autonomous Processing

This article captures key takeaways from a BioProcess International keynote by Preeya Boppana, director of MSAT process analytics and laboratories at AstraZeneca, titled “Transforming Biologics Manufacturing: Leveraging Predictive Analytics and Advanced Process Control for Next-Generation Operations.”

Prioritizing Quality Over Everything

Regulatory compliance and cGMP manufacturing expert Tatyana Matveeva, Ph.D., explains the role and importance of a quality unit in an organization, as well as what happens when it’s compromised.

Evaluating The Levers Driving Productivity In Bioprocessing

Experts discuss where productivity gains can be achieved and how development teams should seek to improve process performance in this recap of the Bioprocess Online Live event "The Levers And Tradeoffs That Drive Process Productivity."

Overcoming Recovery Challenges In AAV Production

Siren Biotechnology's SVP of vector development, Nathalie Clément, Ph.D., explains the challenge of purifying AAV capsids and the ways developers are optimizing vector recovery.

GUEST COLUMNISTS

September 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs?
FDA’s real-time CRL releases face legal and operational hurdles. Could AI-assisted redaction make transparency faster and more consistent?
Navigating Outsourced Pharmaceutical Testing Through Today's Geopolitical Uncertainty
Geopolitical shocks are reshaping outsourced pharmaceutical testing. Learn how procurement teams can strengthen resilience and protect continuity.
Is Your Supply Chain Ready For The End Of Class VI?
Revisions to USP <87> and <88> update biological reactivity testing — changes that are especially important for companies that rely on single-use technology.
When Lyophilization Fails At Scale, First Scrutinize Your Formulation
When lyophilizing a challenging biologic drug product, use an integrated approach optimizing formulation and process parameters together.
The 5 Shifts That Could Remake Lyophilization By 2040
Purdue University-based LyoHUB charts a risk-based course to modernizing freeze-drying technology for better performance and advanced modalities.
Complete Response Letters For CGTs Share This Common Theme
One expert’s analysis found CMC-related concerns in about 75% of complete response letters. He outlines a path to stronger CMC readiness for cell and gene therapies.
Your 7 Decisions To Make Before MES Configuration
Don't wait until manufacturing execution system (MES) configuration to answer these 7 questions. Define your manufacturing process before digitizing it.

BIOPROCESSING WHITE PAPERS

Eliminate Variability, Accelerate Results: Value Of Ready-To-Use Reagents
Pre-made solutions reduce operator variability, save bench time, and lower contamination risk by eliminating reagent preparation and reducing handling.

Quality By Design (QbD) For Biologics From A CDMO Perspective
2/18/2025

Adopt QbD principles in your biologics development and manufacturing process to ensure consistent product quality, mitigate risks, and align with patient safety and commercial success goals.
From Laboratory To Launchpad: Japan's Cell And Gene Therapy Ecosystem Hits Its Stride
10/21/2026

Japan is emerging as a credible cell and gene therapy hub as regulation, manufacturing, and capital advance, despite gaps in funding, talent, risk culture, and language.
Quality: The Link Between Platform, Processes, And Patients
2/18/2025

Quality management in healthcare and life sciences is crucial for optimizing patient health. Learn how modern quality management systems optimize patient outcomes, enhance safety, and drive operational efficiency.
A Faster Path To Genomic Medicine Feasibility
3/17/2026

Life Edit accelerates genomic medicine by comparing five editing modalities, engineering new enzymes, and rapidly pinpointing optimal strategies that boost feasibility, cut risk, and speed clinical progress.
Streamline Your mAb Manufacturing With Strategic Development And CDMO Compatibility
6/4/2025

Though the journey to mAb development begins at lab scale, for clinical trials and commercial distribution, a production process must be streamlined and scalable to 2,000 L production and above.

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BIOPROCESSING APP NOTES & CASE STUDIES

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EDITORIAL COLLECTIONS KNOWLEDGE CENTER

Editorial Collections are subscriber-only, curated resources that combine expert interviews, feature articles, and industry analysis to help readers better understand emerging trends, operational challenges, regulatory developments, and best practices shaping the biopharma industry.

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