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What Europe's Draft Annex 22 Actually Asks Of Human Oversight Of AI

The European Commission and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) consulted on draft Annex 22, Artificial Intelligence. Here's what you should know.

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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

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.
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.

BIOPROCESSING WHITE PAPERS

Navigating Complex OSD Challenges With Predictive Insights
Learn how predictive modeling, advanced material characterization, and data-driven process insights support manufacturing readiness and confident launch decisions.

Deciphering The Complex Characteristics Of Nanomedicine
5/6/2026

Gain deeper insight into nanomedicine characterization, showing how critical quality attributes, advanced analytics, and phase‑appropriate strategies drive safety, efficacy, and regulatory readiness.
Where Innovation And Investment Reduce Drug Development Risk
6/12/2026

How strategic investments in development, manufacturing, and clinical supply are helping organizations reduce risk and accelerate drug development.
Process Intensification And Other Ways To Adapt To Changing Needs
7/20/2026

As biologics manufacturing evolves, gain insight into why productivity depends on smarter investments, flexible production strategies, and supplier support that can address shifting modalities.
FM Approval Standard 4882
9/21/2026

A fire in a pharmaceutical cleanroom can be contained, but for sterile manufacturers, smoke can turn a localized event into a far wider decontamination, requalification, and production-recovery challenge.
Antibody-Based Drug Discovery At The Speed Of Light
5/23/2025

Review this end-to-end workflow, including First-to-Human antibody development strategies, the use of the PentaMice® platform for targeted immunization, and the precision of single B cell screening.

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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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