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Beyond The Plate Count: How To Build A Defensible Environmental Monitoring Trend Review

Determining whether a drug manufacturing environment is stable, drifting, or developing a recurring loss-of-control signal requires integrated trend evaluation.

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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

How To Keep Your 'Big Bang' Platform Switch From Becoming A Big Bust
Leaders at a Roche fill/finish facility describe the tactile steps involve to change EMS, ERP, and WMS all at once with no rollback option.
How Is Your Glass Supplier Adapting To Europe's Energy Crisis?
Europe's glass manufacturers, including those making pharmaceutical lab glassware, have experienced a series of energy shocks. Many have adopted sustainability practices.
Fine-Tuning Bioseparation Column Geometry With 3D-Printed Monoliths
If geometric control, not retention, is the priority in viral vector separation, research group says high-resolution 3D-printing chromatography monoliths can be useful.
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.
Can Peptide Mapping Predict Intact Antibody PTM Distributions?
Peptide mapping quantifies modification at individual sites, but the same site-level results can correspond to different distributions across intact molecules.
How To Stand Up A Hospital-Based CAR-T Manufacturing Network
Estimates show that a small hospital-based, modular GMP facility can deliver more than 250 products per year with more flexibility than fully automated, integrated equipment.
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.

BIOPROCESSING WHITE PAPERS

Factors Influencing CD34+ Cell Collection Efficiency In Leukapheresis
Efficiently collecting sufficient peripheral blood stem cells is paramount for successful transplantation, necessitating a deeper understanding of influencing factors and procedural nuances.

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.
Optimize Time, Space and Cost With Inline Buffer Formulation And System
4/7/2026

Discover how integrating inline buffer formulation with chromatography reduces buffer waste by 50% and delivers a 710% ROI, transforming downstream efficiency and sustainability.
Advancing Cell Culture Strategies To Accelerate Biologics Development
5/5/2026

Integrated stable expression strategies accelerate biologics material generation, improving scalability, consistency, and early developability insights while reducing bottlenecks, variability, and risks in transitioning from discovery to manufacturing.
Why A Paperless Approach Is A Non-Negotiable In CQV
6/9/2026

Regulatory expectations are forcing a shift away from paper-based validation toward digital systems that enable faster execution, stronger oversight, and more reliable, audit-ready CQV processes.
Optimal Microbial Sampling Criteria
6/24/2025

Microbiological sampling ensures sterile conditions through surface, passive, and active air methods. The EU GMP Annex 1 emphasizes integrating these for comprehensive environmental monitoring.

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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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