A cleaning validation professional must know how many process performance qualification runs are necessary. Here's how to go about demonstrating this with a high degree of assurance while minimizing the number of qualification runs.
- Why 'Which Is Best?' Is The Wrong Question In CGT Development
- Finding Compatibility In Love And CDMO Partnerships
- Five Takeaways from BIO 2025 and Why You Should Stay Tuned
- Lonza Bets On Biologics. What's It Mean For You?
- Understanding FDA's New National Priority Voucher Pilot Program
- BIO2025 Recap: FDA Reducing Animal Testing, Governor Shapiro On Supporting Biopharma, Practical AI Use
- The Latest Techniques And Technology For Differentiating Capsids
EDITOR'S DESK
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Lonza Bets On Biologics. What's It Mean For You?
It’s a large and universally recognizable CDMO, so this matters. Swiss-based powerhouse Lonza will increase its focus on biologics, and “advanced synthesis” including for antibody-drug conjugates (ADCs), cell and gene therapies (CGT), and mRNA therapeutics. Will other CDMOs follow suit? What's this say about the future of development outsourcing and our industry?
Bioprocess Online chief editor Tyler Menichiello shares his three key takeaways from the 2025 BIO International Convention.
This summary features key takeaways from the Bioprocess Online Live event, "Challenges And Considerations For Purifying Multispecific Molecules."
Autolus Therapeutics' COO talks about the accelerated construction of the company's cell therapy manufacturing facility, The Nucleus.
Bioprocessing facility expert Herman Bozenhardt responds to some unanswered audience questions from a Pharmaceutical Online Live event on facility design and validation.
GUEST COLUMNISTS
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Understanding FDA's New National Priority Voucher Pilot Program
The FDA's vouchers will be issued to companies addressing health issues in the U.S. and increasing domestic manufacturing, among other criteria.
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The Latest Techniques And Technology For Differentiating Capsids
Since AAV gene therapy’s origins, scientists and regulators have sought optimized ways to measure empty/full capsids. This expert reviews pros and cons of modern methods.
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AI-Assisted QMS: Bridging ISO/IEC 42001:2023 And ICH Q10 For Pharmaceutical Excellence
Integrating AI into quality management systems (QMS) can be a transformative opportunity to enhance quality assurance, improve compliance, and enable proactive risk management.
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Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future Oversight
Recent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political and economic pressures. Here are the newest developments and emerging focal points.
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Ask The Pros — The Latest In Downstream HCP Mitigation
Two downstream biologics processing experts address some of the field's complex, nagging questions about mitigating host cell proteins.
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How Is RIM Software Transforming Regulatory Compliance?
Regulatory information management (RIM) software tools streamline global regulatory processes on a single cloud-based platform throughout the entire product life cycle.
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Draft EMA Doc Proposes More Flexibility On Biosimilar CES Requirements
Clinical efficacy studies may not be necessary under certain conditions, writes the European Medicines Agency in a new draft reflection paper.
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Exploring The Market For Closed-Loop Cell Therapy Production
The second part of a discussion on closed-loop systems explores the CDMO and equipment landscape for scaling automated closed loop cell therapy manufacturing systems.
BIOPROCESSING WHITE PAPERS
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Optimizing Poloxamer 188
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.
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Overcoming Efficiency And Quality Challenges In Gene Therapy Development10/8/2024
Review the importance of collaboration and innovation in addressing the challenges with scaling up gene therapy production, from adopting new cell lines to integrating AI in process optimization.
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Tech Transfer At Risk: The Imperative For Digital Maturity, Modernization12/2/2024
Tech transfer is critical for biopharmaceutical production, but outdated tools can hinder the process. Discover how digital maturity can streamline operations, reduce risks, and accelerate time to market.
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Regulatory Frameworks For mRNA Therapeutics3/17/2025
The RNA therapeutics and vaccines market has grown rapidly, driven by siRNA and mRNA technologies. Explore how these advancements are now being applied to cancer vaccines and innovative therapeutics.
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Super Short Activated CAR-T Process1/17/2025
Experience the benefits of faster, more effective CAR-T cell production with this innovative three-day short-cycle process, designed to enhance patient treatment outcomes while reducing costs.
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Building A Legacy In Sterile Injectables Through Strong CMO Synergy5/7/2025
Examine how a CMO can deliver significant value to drug developers by fostering successful outsourcing relationships, streamlining the path to market, and supporting demands.
BIOPROCESSING APP NOTES & CASE STUDIES
- Re-Imagining Chromatography: Building Efficient Downstream Processes
- Streamlining Compliance With Pre-Clinical Safety Tests
- Comprehensive Peptide Mapping Of Protein Therapeutics
- Using Precision Fermentation To Produce Animal-Free Milk Proteins
- Analytical Method Release And Stability Platform For RNA Drug Substance

- How CGT Leaders Are Reducing Failures, Scaling Processes, And Overcoming Regulatory Friction
- Finding Compatibility In Love And CDMO Partnerships
- BIO2025 Recap: FDA Reducing Animal Testing, Governor Shapiro On Supporting Biopharma, Practical AI Use
- Analytics And Cross-Functional Communication: Keys To Purifying Complex Molecules
- How Modular Facility Design Can Accelerate GMP Facility Construction
- A Facilities Expert Answers Audience Questions On Construction And Validation
- Experts' Advice On Facility Design And Construction
BIOPROCESS ONLINE CONTENT COLLECTIONS

This collection of articles digs into the industry’s growing focus on knowledge management as an indispensable facet of biomanufacturing and pharmaceutical development, exploring how it plays into risk management, quality, vendor relationships, and supply chain resilience.
More Content CollectionsFEATURED PRODUCTS AND SERVICES
ON-DEMAND WEBINARS
- Quality Control During Membrane Protein Purification For Cryo-EM
- Transposase-Enabled CLD: From Transfection To High Titer With Ease
- Advancing GLP-1 Analog Drug Development Using A Variety Of Techniques
- Optimize Your mAb Capture And Polishing With The Latest Resins And Tips
- Scaling Up Your E. Coli pDNA Process From Parameter Screening To Pilot Scale
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 07.02.25 -- Ask The Pros — The Latest In Downstream HCP Mitigation
- 07.01.25 -- Exploring The Market For Closed-Loop Cell Therapy Production
- 06.30.25 -- Helpful Biosafety Testing Innovations For mAbs Development And Manufacturing
- 06.30.25 -- Does Continuous Complexity Outweigh Its Benefit?
- 06.27.25 -- STREAM Edition: Big Pharma Insights For Building Biotech Startups