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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.

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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

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.
DEA Reveals Hidden Costs Of Analytical Validation Guidelines
By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.

BIOPROCESSING WHITE PAPERS

Context-First Data For Trustworthy AI In Biopharma
Bridge the gap between AI experimentation and enterprise value. Learn how capturing structured, semantically rich data at the point of origin builds regulator-credible AI pipelines.

Immunogenicity Risk Assessment In Drug Candidate Selection
1/22/2025

Identify and address potential anti-drug immune responses early in development to streamline your drug’s path to clinical success—start smart and finish fast.
Redefining Value In Biologics Outsourcing Partnerships
6/25/2026

Biologics outsourcing is shifting to strategic partnerships focused on modality expertise, regulatory excellence, and integrated end-to-end capabilities.
The Proven, Practical Gateway To Upstream Process Intensification
11/18/2025

N-1 perfusion enables higher inoculum densities, faster production, and reduced costs without altering fed-batch processes. Explore a practical path to intensification for biologics manufacturers.
Expanding Translational Research Concepts With Genedata Profiler
11/26/2024

The biopharma industry leverages Genedata Profiler to integrate, curate, and analyze diverse R&D data, enabling collaborative, compliant, and AI-driven translational research to optimize drug development.
(Cross-) Contamination Control Through Effective Equipment Cleaning
5/6/2026

Discover science-driven cleaning strategies that reduce cross-contamination, enable safe multiproduct manufacturing, and support faster, flexible GMP changeovers.

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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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