Revisions to USP <87> and <88> update biological reactivity testing — changes that are especially important for companies that rely on single-use technology.
- 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
- DEA Reveals Hidden Costs Of Analytical Validation Guidelines
- Qualification And Validation Of Depyrogenation Tunnels And Autoclaves
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AstraZeneca's Focus On Predictive Control, Semi-Autonomous ProcessingThis 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.
ADCs built on proprietary platforms risk losing process-specific knowledge during a tech transfer. See what advice panelists from the Bioprocess Online Live event "Ensuring Successful Technology Transfer In ADC Development" shared with the audience on preserving this implicit knowledge.
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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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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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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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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 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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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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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.
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August 2026 — CDMO Opportunities And Threats ReportEach month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
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Biopharma Supply, Reimagined: Regional, Resilient ManufacturingPersistent disruption is redefining biopharma supply chains. Explore how regional manufacturing, integrated risk management, and closer collaboration help build resilience and improve agility.
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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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The Importance Of Polymorph Screenings5/6/2026
Discover how systematic polymorph screening reduces development risk, safeguards product performance, and enables confident solid‑form selection across the drug development lifecycle.
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The Importance Of Quality In Raw Material Selection1/16/2025
Learn how to select high-quality raw materials for cell-based manufacturing in this exploration of the criticality of raw materials, from preclinical development to commercialization.
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Achieve Higher Targeted Concentrations9/30/2025
Single-pass TFF streamlines downstream processing by reducing footprint, shear exposure, and hold-up volumes. Learn how this approach is advancing efficiency across therapeutic and vaccine production.
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Application Of Plant And Process Models1/22/2025
Explore innovative process and facility models that optimize efficiency, sustainability, and cost-effectiveness in biopharmaceutical manufacturing.
BIOPROCESSING APP NOTES & CASE STUDIES
- Microbial Integrity Of Sampling Systems After Multiple Actuations
- Scalable rAAV9 Production Using Advanced Cell Lines And Bioreactors
- An Innovative Solution For Continuous Low pH Flow-Through Virus Inactivation
- Ultra-Low Cross-Linked Microgel Purification
- Walk-Away Monitoring Of Cytotoxicity, Viability, And Apoptosis
- 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
- Overcoming Recovery Challenges In AAV Production
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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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- Reducing Plastic While Strengthening Brands And Industrial Performance
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NEWSLETTER ARCHIVE
- 10.22.26 -- Controls For Retrieval-Augmented Generation In GxP
- 10.21.26 -- A Sustainable Future: Leveraging 3Rs To Innovate And Accelerate In Testing
- 10.21.26 -- Finding Balance Between Viral Vector Purity And Quantity
- 10.20.26 -- Reduce risk. Move Annex 1 forward.
- 10.20.26 -- August 2026 — CDMO Opportunities And Threats Report