Bioprocess Online connected with James Colley, Ph.D., senior director of BioPhorum’s IT and Digital Data Phorum, ahead of his session at BPI for an interview on the state of AI adoption in biopharma.
- 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
- The 5 Shifts That Could Remake Lyophilization By 2040
- On The Ground At BPI: Jacqualyn Schulman, Ph.D., On Accelerating Clonal CLD
- Complete Response Letters For CGTs Share This Common Theme
- Your 7 Decisions To Make Before MES Configuration
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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![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.
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![Quality assurance, approved network-GettyImages-2247428372]( "Qualification And Validation Of Depyrogenation Tunnels And Autoclaves")
Qualification And Validation Of Depyrogenation Tunnels And AutoclavesSystemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization.
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![FDA-GettyImages-2271213876]( "FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters")
FDA Modernizes Container Closure Guidance: What Is Changing And Why It MattersThe proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.
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![health hands icon symbol logo-GettyImages-893252564]( "Engineering Better ADCs, Part 2: Characterization, CMC, And More")
Engineering Better ADCs, Part 2: Characterization, CMC, And MoreLet's take a closer look at antigen selection and tumor biology, PK and PD, analytical characterization, CMC, toxicity, and more.
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![doctor and businessman shaking hands-GettyImages-1098284170]( "CDMO Selection Beyond Capabilities And Price")
CDMO Selection Beyond Capabilities And PriceSome of the most useful information relevant to CDMO selection is also the hardest to obtain. Here are suggestions for uncovering data that tells the whole capability story.
BIOPROCESSING WHITE PAPERS
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![GettyImages-1327977866-cell-culture-sample-laboratory]( "Unlocking ROI And Capacity In Monoclonal Antibody Manufacturing")
Unlocking ROI And Capacity In Monoclonal Antibody ManufacturingPerfusion-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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Random And Semi-Targeted Integration In Cell Line Development8/5/2025
While semi-targeted approaches may offer precision, uncover how they may fall short in overall efficiency and productivity, especially in late-stage manufacturing.
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Delivering Critical Therapies With Speed And Safety6/26/2026
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.
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Smarter By The Second Redefining Pharma Biopharma Manufacturing6/2/2026
Continuous monitoring is transforming manufacturing. With advanced analytics and sensor technologies, teams can detect issues early and optimize processes in real time for greater efficiency.
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Engineering The Future Of Antibody-Drug Conjugates6/26/2026
As ADCs expand into broader use, upstream process design is becoming a competitive advantage. Discover how smarter media strategies and data-driven decision-making are helping teams reduce risk.
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Criteria For Effective Bioprocess Scale-Up3/25/2026
Discover four essential bioprocess scale-up criteria and how each balances hydrodynamics, shear, and mass transfer across manufacturing scales.
BIOPROCESSING APP NOTES & CASE STUDIES
- Select The Best Analyte: A Guide To Effective Mycoplasma Testing
- Integrated Upstream And Downstream Strategies For Robust Manufacturing
- How Automated NGS Solutions Advance Rare Disease Research
- Application Of A Dual Spiking Strategy In Viral Clearance Studies
- Improve Productivity And Reduce Risk With Biostat® RM
- 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 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
- Maintaining Process Consistency And Performance During Scale-Up
- Scaling ADC Manufacturing Without Compromising Quality
- Reducing Plastic While Strengthening Brands And Industrial Performance
- Advancing Drug Product Manufacturing With A Risk-Based Approach
- Building a Global Manufacturing Network: "Dual-Sourcing" Commercial Strategies
INDUSTRY NEWS
NEWSLETTER ARCHIVE
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