• Tech-Heavy Drug Discovery Yields Deep Pipeline

    Recursion Cofounder and CEO, Chris Gibson, Ph.D. is creating a map of human biology comparable to Google’s ongoing effort to map every street on the planet. He shared why that's so important, and how it's informing Recursion's rapid drig discovery efforts.

Engineering Antibodies In A Box?

Machines aren’t smart enough to engineer optimal, disease-specific antibodies without data that’s properly generated, captured, and structured. That’s why LabGenius Founder Dr. James Field says the key to success is neither human-derived data, nor machine-enabled design. It’s the organizational engineering feat of bringing the two together.

Why RNA Is Good For Business

Early last year, Nutcracker Therapeutics landed a $170 million Series C to further its work developing an RNA drug development platform. Learn how scientist-turned Chief Business Officer Geoff Nosrati is lifting the company above the cacophony of companies rallying around the therapeutic potential of RNA.

Key Biomanufacturing Ingredient In Short Supply

Biopharma supply chains and manufacturing capacity are on the comeback trail, but one of the key requirements for sustainable development and manufacturing success remains elusive. NIIMBL Workforce Director John Balchunas shares perspective from a unique vantage point.

Considerations For Licensing Platforms From Universities

Even the best platforms and technologies don’t come out of universities IND-ready. Just ask Coeptis Therapeutics, which recently licensed the novel CAR-T platform, SNAP-CAR, from the University of Pittsburgh. Coeptis’ Dave Mehalick, and Dan Yerace discuss the licensing agreement and the growing pains to expect when preparing a new platform for an IND.


  • Risk Tool Selection With ICH Q9(R1) In Mind

    This article focuses on the formality concept discussed in the revision of ICH Q9 Quality Risk Management released earlier in 2023. The authors provide a helpful overview of what risk tools are appropriate to use during certain types of scenarios, and what the team composition should look like.

  • Moving From Clinical Stage To Commercial? 4 Steps For An Outsourcing Strategy

    If you're a pre-commercial bio/pharma looking ahead to commercial stage, evaluating partnerships are faced with making key decisions around which capabilities to outsource, the degree of data access and ownership, and which external partners are the right fit. Here are four key actions to consider.

  • Guidelines For mRNA Drug Product Manufacturing And Quality Control

    The lightning fast rise of mRNA raised the need for manufacturing standards and consensus on product quality attributes and test methods. This article provides perspective and insight on PQAs for mRNA vaccines and other mRNA-based products.

  • Emerging Market Trends For APIs

    The active pharmaceutical ingredient (API) market is estimated at $158 billion in 2023 and is projected to reach $232 billion by 2028. This article shares new market research on APIs, including an analysis of innovative and generic APIs, synthetic and biotech APIs, and more.

  • Your Best Chance At Regulatory Compliance For Combination Products: Integrated Development

    The FDA now defines a prefilled syringe, a product that was at one point considered “packaging” for a drug, as a constituent part of a combination product. The ultimate combination of the drug, its package, and its delivery device means that during development and manufacturing you need to combine both drug and device current good manufacturing practices (cGMPs) and quality approaches.

  • How Strategically Partnering With Academia Supports Biotech R&D Goals

    For early-stage biotechs, partnering with leading academic institutions can help your firm cut costs and boost the returns on R&D investments while making key research and industry connections that can assist in the development, and ultimate commercialization, of your drug/therapy products.

  • Comparing FDA And EMA Approaches To AI/ML In Drug Development & Manufacture

    Considering the feverish pace of innovation in the field of AI/ML and the inevitable impact on drug development, we outline the documents and guidances that the FDA and EMA have released thus far, comparing and contrasting their areas of focus and concern. 

  • How To Implement Size Exclusion Chromatography And Mitigate HCP Risk

    Research shows size-exclusion chromatography improves the host cell protein detection capabilities of liquid chromatography-tandem mass spectrometry. This guest article explores the strategy of using both to better understand HCP persistence in the purification process.





Biopharmaceutical supply chain strategies can be profoundly bespoke, but best practices like redundancy and quality risk management offer a starting point. The ideas in this collection of recent articles from Bioprocess Online can help shore up your own network in defense of the next upset.

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