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Comparing Advanced Modality Needs, Part 1: Manufacturing

ADCs, AOCs, ATMPs, cell and gene therapies, and oligonucleotide therapeutics represent distinct but interconnected approaches to precision medicine. Let's take a closer look at their manufacturing needs.

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EDITOR'S DESK

Contextualizing Data To Enable AI And Prevent Knowledge Leaks
Bioprocess Online's Tyler Menichiello interviews Martin Kockx, a principal manufacturing systems engineer at Vertex Pharmaceuticals, on his presentation at 2026 BPI, “Transforming Biomanufacturing: Why Architecture Must Precede Analytics."

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."

GUEST COLUMNISTS

Closing The Gap Between Modeling And GMP Predictive Control
Predictive control offers opportunities to improve process consistency, reduce variability, and respond to changing manufacturing conditions before they cause deviations.
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.

BIOPROCESSING WHITE PAPERS

Accelerating Drug Development: Solid State Chemistry And Strategic Outsourcing
Discover how phase‑appropriate solid‑state chemistry and strategic outsourcing reduce risk, speed development timelines, and enable confident solid‑form selection for complex small‑molecule programs.

Digital CMC Maturity: Rethinking QTTP And Control Strategy
9/2/2026

Digital CMC maturity depends on structured, science- and risk-based knowledge. Learn how connecting development, validation, regulatory, and lifecycle information can accelerate timelines.
Controlling Complexity In ADC Formulation Development
9/9/2026

ADC formulation development requires a molecule-specific approach that accounts for the interplay between antibody, linker, and payload, and the stability trade-offs that mAb development experience cannot fully anticipate.
Delivering Critical Therapies With Speed And Safety
6/26/2026

Faster approvals depend on treating regulation as part of development, not the finish line. See how early quality planning and strong agency communication can move therapies toward patients sooner.
The Current And Future Value Of mRNA Vaccines And Therapeutics
2/4/2026

Discover how decades of research have propelled mRNA technology to the forefront of therapeutic development and learn how our expertise is advancing mRNA drug development.
Leveraging Digitalization To Resolve CGT Manufacturing Challenges
2/12/2025

Uncover digitalization's role in overcoming manufacturing challenges in cell and gene therapies to enhance efficiency, quality, and scalability through data analytics and real-time 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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