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-2179880251-digital-validation-hands-blue]( "The Future Of Cleaning Validation")
The Future Of Cleaning ValidationExplore evolving cleaning validation strategies in life sciences, from regulatory foundations to digital innovations, and discover how agile, risk-based approaches can enhance compliance and efficiency.
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How Integration Is Redefining Speed, Scale, And Sustainability5/13/2026
Integrated manufacturing ecosystems help biologics programs adapt to changing demand across the product lifecycle. Discover flexible scaling strategies that improve speed, efficiency, and sustainability.
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Leveraging Efficiency From CLD To Clinical Manufacturing Of mAbs2/4/2026
Discover how our efficient strategies can propel your mAb from discovery to clinical manufacturing in as little as 18 months.
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Enabling Digital Twins With Computational Fluid Dynamics Modeling1/16/2025
Embrace the transformative power of predictive modeling and digital twin technology to optimize bioprocess efficiency, ensure product quality, and drive innovation in biopharmaceutical manufacturing.
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Single-use Mixing Systems For Protein Products: Dissolution And Mechanical Stress10/14/2026
Mixer design and fill volume shape both how well a solution homogenizes and how much mechanical stress a protein experiences. Impeller configurations are compared against a conventional stirrer.
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Learn, Confirm, Then Scale: A Leader's Guide To Transforming QC1/21/2026
Legacy lab systems hinder innovation and scalability. Explore a proven approach to modernize QC through cloud-based LIMS, starting with small pilots that validate strategy and reduce risk.
BIOPROCESSING APP NOTES & CASE STUDIES
- 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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- Maintaining Process Consistency And Performance During Scale-Up
- Scaling ADC Manufacturing Without Compromising Quality
- Reducing Plastic While Strengthening Brands And Industrial Performance
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