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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

Closing The CAR-T Access Gap With Hospital-Based Manufacturing
Improvements in closed-loop processing and lower material costs could bring distributed manufacturing within reach. Hospitals still need to stand up production suites.
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.

BIOPROCESSING WHITE PAPERS

Optimizing Bioprocess Design And Workflow Orchestration
Disconnected systems can slow development by making data harder to coordinate. Learn how workflow orchestration and structured experimental design can help labs reduce friction and improve efficiency.

High-Throughput Binding Affinity Assessment Using Octet® HTX
10/22/2026

Binding affinity screening of clones directly from crude supernatant, without purification, changes what can be assessed early, and a tiered workflow pairs broad throughput with deeper analytical characterization.
Validating Tubing For Closed-System Bioprocessing
9/27/2026

Uncover how advanced tubing materials improve weld integrity, reduce particulates, and support sterilization compatibility for closed-system bioprocessing.
The AI-Ready Factory: How IT/OT Integration Transforms Manufacturing Data
7/21/2026

Pharmaceutical manufacturers need more than raw production data to scale AI. Learn how contextualized, governed IT/OT integration can turn disconnected shop-floor signals into real-time decisions.
Factors Influencing CD34+ Cell Collection Efficiency In Leukapheresis
6/3/2025

Efficiently collecting sufficient peripheral blood stem cells is paramount for successful transplantation, necessitating a deeper understanding of influencing factors and procedural nuances.
Avoiding The Pitfalls Of APQR
6/9/2026

Traditional quality reviews often fall short in today’s data-heavy environment. A real-time, digital-first approach enables faster insights, stronger compliance, and more proactive quality management.

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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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