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Why CMC Must Shape Critical Decisions Early In Development

Case studies reveal the gap between research progress and clinical readiness. In these stories, earlier CMC involvement might have saved resources and staved off delays.

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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

IT/OT Convergence Could Lighten Biopharma's Automation Burden
Integration lets frameworks talk to each other through middleware. Convergence brings them under the same architecture, which can can reduce costs and maintenance.
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.
Want More Sustainable Biopharma Packaging? Try These Levers
Biopharmaceutical packaging optimization must not compromise the goods inside or compliance, so sustainable packaging developers might need to think outside the box.
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.
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.

BIOPROCESSING WHITE PAPERS

Late‑Stage Progress In Excipients For Precision Nanomedicine
View late‑stage development and GMP manufacturing of novel excipients for nanomedicines, emphasizing regulatory rigor, process optimization, analytics, and scale‑up for lipid‑based delivery systems.

ADCs As Biological Missiles For Targeted Therapies
6/15/2026

Antibody-drug conjugates are reshaping cancer treatment. Learn how monoclonal antibody targeting, linker design, and next-gen payloads are defining the future of precision oncology.
Tailoring Viral Clearance Study Design
3/4/2026

Viral‑clearance studies need phase‑appropriate design, strong virus stocks, modality‑specific risk assessment, and alignment with evolving regulations for reliable safety outcomes.
Quality By Design: Understanding And Securing Virus Clearance
4/22/2026

Data-driven virus clearance improves risk assessment, process insight, and study design. Learn how Quality by Design cuts late-stage risk while strengthening regulatory confidence and viral safety.
Biocapacitance Measurement: A PAT Tool For Biomass Measurement In An Upstream Process
3/20/2026

Leverage process analytical technologies (PAT) to gain real-time insight into product quality, strengthen control strategies, and build more efficient, scalable manufacturing processes for future success.
Systemic Modularity: A Roadmap To Flexible, Efficient Biopharmaceutical Manufacturing
8/13/2026

Modernizing biomanufacturing requires shifting from rigid, custom setups toward modular automation, data-rich sensors, and plug-and-produce operations.

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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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