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-2157709105-digital-transformation-fabric-blue-purple]( "Connected. Intelligent. Compliant. The Next Leap In Pharma Manufacturing")
Connected. Intelligent. Compliant. The Next Leap In Pharma ManufacturingExplore how Industry 4.0 integration transforms pharma manufacturing through connected systems, data-driven insights, and predictive, compliant operations.
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The Open Standard For Plug-And-Produce4/14/2026
Take a look at how standardized, modular production simplifies line integration, reduces engineering effort, and enables faster changeovers. Ideal for teams seeking flexible manufacturing models.
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Accelerating An Innovative High Potency Oncology Therapy To Market5/13/2026
Assimilate how disciplined containment, proactive risk management, and collaboration accelerate oncology programs under tight timelines while protecting quality, safety, and global launch readiness.
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T Cells In Immunotherapies: The Key Progress Underway6/1/2026
CAR-T therapies now make up 73% of active pipeline programs, yet solid tumors remain largely out of reach. Where is T cell immunotherapy headed next, and what does it mean for your pipeline strategy?
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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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Endotoxin Control In The Process Development Lab10/13/2026
Endotoxin control in E. coli fermentation depends on effective removal, purification, and NaOH cleaning strategies, with risks evolving as manufacturing progresses.
BIOPROCESSING APP NOTES & CASE STUDIES
- 3D Neurospheres In Healthy And Alzheimer's: iPSC-Derived Neurons
- Intact- And Peptide-Level Characterization Of T-DM1 In Vitro
- Adherent PSC Expansion: Key Considerations For Scalable Manufacturing
- Visualizing The Metabolic Profile Of Immune Cells With Metabolic Inhibitors
- Levers To Optimize The IVT Reaction For Increased mRNA Yield
- 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
- 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
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