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.
- An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs?
- On The Ground At BPI: Where AI Dreams Meet Operational Reality
- Navigating Outsourced Pharmaceutical Testing Through Today's Geopolitical Uncertainty
- Is Your Supply Chain Ready For The End Of Class VI?
- On The Ground At BPI: Tatyana Matveeva, Ph.D., On Distributed Manufacturing Models
- When Lyophilization Fails At Scale, First Scrutinize Your Formulation
- Contextualizing Data To Enable AI And Prevent Knowledge Leaks
EDITOR'S DESK
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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.”
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.”
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.
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."
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
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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?
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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.
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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.
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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.
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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.
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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.
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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.
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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
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Expanding The Capabilities Of Targeted Integration
See the demonstration of precise, site‑specific integration of a 50 kb multi‑gene construct into human iPSCs, overcoming size limits of traditional genome‑engineering approaches.
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Antibody Drug Conjugates Re-Emergence Of An Old Modality5/26/2026
Antibody-drug conjugates link targeted antibodies with potent drugs to treat cancer more precisely, though challenges remain in stability, conjugation, and scalable production.
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Building Late-Stage Efficiency Into Biologics Development8/6/2026
Building late-stage efficiency early in biologics development prevents scale-up delays. Flexible platforms and risk-based validation streamline technology transfer and lower production costs.
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Optimizing Bioprocess Design And Workflow Orchestration7/30/2026
Disconnected systems can slow development by making data harder to coordinate. Learn how workflow orchestration and structured experimental design can help labs reduce friction and improve efficiency.
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High-Throughput Binding Affinity Assessment Using Octet® HTX10/22/2026
Binding affinity screening of clones directly from crude supernatant, without purification, changes what can be assessed early, and a tiered workflow pairs broad throughput with deeper analytical characterization.
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Why Reagent Quality Defines Research Success10/15/2026
Water grade, buffer preparation, and packaging each shape whether sensitive assays hold up. Reagent selection hinges on matching purity to application sensitivity, regulatory standards, and tolerance for contamination risk.
BIOPROCESSING APP NOTES & CASE STUDIES
- Large Scale Purification Of Oligonucleotides With IEX
- Don't Intensify Blindly: Preventing Fouling And Restoring Performance With Targeted Cleaning Of Protein A Resins
- Characterization Of Antibody-Drug Conjugate Critical Quality Attributes
- Facility-Fit-Driven Process Development For A Monoclonal Antibody
- Fluorescent Bacterial Colony Selection
- On The Ground At BPI: Where AI Dreams Meet Operational Reality
- On The Ground At BPI: Tatyana Matveeva, Ph.D., On Distributed Manufacturing Models
- Contextualizing Data To Enable AI And Prevent Knowledge Leaks
- On The Ground At BPI: Jacqualyn Schulman, Ph.D., On Accelerating Clonal CLD
- AstraZeneca's Focus On Predictive Control, Semi-Autonomous Processing
- Prioritizing Quality Over Everything
- Evaluating The Levers Driving Productivity In Bioprocessing
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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ON-DEMAND WEBINARS
- Rethinking Starting Material: Whole Blood For Autologous T-Cell Manufacture
- Unlocking Hidden Efficiencies In Cell And Gene Therapy Manufacturing
- Engineering Affordability Into Customizable Microscopy Platforms
- Connecting Oligonucleotide R&D With Early Clinical Scale Manufacturing
- Bioconjugation Scale-Up: Data-Driven Strategies From 10 L To 500 L
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 10.29.26 -- The Freeze-Drying Step That Affects Every Stage After It
- 10.29.26 -- What's Being Overlooked In Biopharma Manufacturing?
- 10.29.26 -- Early Developability Assessment Reduces Risk In Multi-Specific Antibody Programs
- 10.29.26 -- Measuring The Success Of A Technology Transfer
- 10.29.26 -- Fluid Management Solutions To Strengthen Yield, Control, And Efficiency

