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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![GettyImages-2290999457]( "On The Ground At BPI: Jacqualyn Schulman, Ph.D., On Accelerating Clonal CLD")
On The Ground At BPI: Jacqualyn Schulman, Ph.D., On Accelerating Clonal CLDAn 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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![FDA-GettyImages-2271237562]( "An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs?")
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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![maritime trade protection, logistics cybersecurity, and global supply chain safety-GettyImages-2264675121]( "Navigating Outsourced Pharmaceutical Testing Through Today's Geopolitical Uncertainty")
Navigating Outsourced Pharmaceutical Testing Through Today's Geopolitical UncertaintyGeopolitical shocks are reshaping outsourced pharmaceutical testing. Learn how procurement teams can strengthen resilience and protect continuity.
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![Wave bioreactor set for Laboratory Reactor-GettyImages-1330740780]( "Is Your Supply Chain Ready For The End Of Class VI?")
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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![Glass Vial, medication powder-GettyImages-876484700]( "When Lyophilization Fails At Scale, First Scrutinize Your Formulation")
When Lyophilization Fails At Scale, First Scrutinize Your FormulationWhen lyophilizing a challenging biologic drug product, use an integrated approach optimizing formulation and process parameters together.
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![hand holding vial-GettyImages-951661874]( "The 5 Shifts That Could Remake Lyophilization By 2040")
The 5 Shifts That Could Remake Lyophilization By 2040Purdue University-based LyoHUB charts a risk-based course to modernizing freeze-drying technology for better performance and advanced modalities.
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![FDA Headquarters MD-GettyImages-2278014569]( "Complete Response Letters For CGTs Share This Common Theme")
Complete Response Letters For CGTs Share This Common ThemeOne 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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![DMAIC, Define, Measure, Analyze, Improve, Control-GettyImages-2103944843]( "Your 7 Decisions To Make Before MES Configuration")
Your 7 Decisions To Make Before MES ConfigurationDon't wait until manufacturing execution system (MES) configuration to answer these 7 questions. Define your manufacturing process before digitizing it.
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![Finding the hidden costs-GettyImages-1478035639]( "DEA Reveals Hidden Costs Of Analytical Validation Guidelines")
DEA Reveals Hidden Costs Of Analytical Validation GuidelinesBy 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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![Molecular docking, Drug discovery research, biochemical binding site, ligand molecule complex-GettyImages-2256560414]( "Drug Substance For Early Clinical Phase Initiation")
Drug Substance For Early Clinical Phase InitiationExplore how proactive nitrosamine impurity risk assessment protects early clinical drug supply, minimizes development delays, and enables confident progression to first‑in‑human studies.
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How Lipid Nanoparticles Enable Next-Gen Delivery10/20/2025
Cell therapy’s future depends on smarter gene delivery. Learn how lipid nanoparticles offer a scalable, cell-friendly alternative to electroporation and viral vectors for manufacturing efficiency.
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An Integrated Analytical Approach To Lipase Risk Management In Biologics Development9/8/2026
Conventional HCP testing cannot confirm whether residual lipases remain enzymatically active. Here, the authors examine why functional activity data are essential for managing polysorbate-related stability risk in biologics development.
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Enhancing Quality And Environmental Monitoring Efficiency Through Paperless Sampling9/9/2026
At roughly 600,000 samples per year, manual EM documentation creates real compliance and operational risk. This whitepaper details how a fully integrated digital sampling system addresses both.
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Unlocking ROI And Capacity In Monoclonal Antibody Manufacturing11/5/2025
Perfusion-based upstream production offers up to 24% lower cost and significantly higher productivity than fed-batch, enabling faster timelines, better facility utilization, and improved quality.
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Optimizing Poloxamer 1881/13/2025
Poloxamer 188 stabilizes proteins in liquid formulations and protects cells from shear stress. Molecular weight and hydrophobicity variations influence its effectiveness in different biopharmaceutical applications.
BIOPROCESSING APP NOTES & CASE STUDIES
- Select The Best Analyte: A Guide To Effective Mycoplasma Testing
- Assessing Quality AAV Attributes Including Aggregation And Capsid Load
- Quantifying Lentiviral Physical Titer Using The QIAcuity dPCR System
- GMP Manufacturing Cycle Time Reduction
- Measuring ADC Positional Isomers Using Nonreduced CE-SDS And HIC
- 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
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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
- 10.30.26 -- Advanced Purification Solutions That Reduce Cost And Process Risk
- 10.30.26 -- Building A Flexible Vaccine Manufacturing Facility With Tonix Pharmaceuticals' Siobhan Fogarty
- 10.30.26 -- Implementing AI Solutions In GMP While Managing Risk
- 10.29.26 -- The Freeze-Drying Step That Affects Every Stage After It
- 10.29.26 -- What's Being Overlooked In Biopharma Manufacturing?