The “Digitization” Of Therapeutics

Precision Nanosystems founder James Taylor, Ph.D. believes genomic medicine will soon dominate, and he says genomic medicine design tools are coming to a laboratory benchtop near you.

Flexible Manufacturing & Single Use: A Story Of Love And Hate

Flexible biopharma manufacturing facilities and the single-use tech that supports them are in vogue, fueled by a groundswell of clinical-stage advanced therapies and the need for speed to advance them. Sarepta’s Brian Winstead shares the ups and downs of the approach at Sarepta Therapeutics.

Adaptive, Precision Trials Change The Clinical Paradigm

Allan Shaw doesn’t just lament the incredible cost and encumbrance of traditional randomized, controlled trials. He has strong opinions on a path forward that’s more efficient for biopharma businesses and more effective for patient populations.

Navigating CDMO Capacities & Capabilities

There’s never been more outsourced manufacturing capacity in play and in process, and it’s still not nearly enough to meet advanced therapeutic manufacturing demand. It’s an awfully tricky time to pick outsourcing partners and meet timelines.


  • 2021’s Bioprocessing Year In Review & 7 Key Takeaways

    The biopharma and bioprocessing industries have responded aggressively and effectively to the COVID-19 pandemic. However, supply chain challenges, shortages, hiring problems, and regionalization have accelerated existing trends and created the need for new strategies. These are just a few of the findings presented in BioPlan Associates’ 2021 18th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production.

  • Calculating Cleaning Process Capability: Analysis Of Total Organic Carbon

    This article will examine a data set of actual total organic carbon (TOC) swab data collected during cleaning validation for a pharmaceutical manufacturing facility and will show how much cleaning process knowledge and cleaning process understanding can be easily obtained through some simple statistical evaluations of such data.

  • US Congress Passes Bill Supporting New Era of Biopharma Advanced & Continuous Manufacturing

    The House recently passed H.R. 4369, which authorizes $100 million over four years to establish National Centers of Excellence in Advanced and Continuous Manufacturing at U.S. academic institutions. This article delves into the news and how it fits into other U.S. initiatives supporting the field.

  • RNA Takes The Spotlight In The Era Of Precision Medicine

    RNA are the protein builders, and now that we have the technology to learn more about them, we have better tools for advancing precision medicine.

  • How To Integrate CPV & APR For Biologics

    In biologics manufacturing, continued process verification (CPV) requirements are similar to those for evaluating quality standards that determine changes to manufacturing or control procedures in an annual product review (APR). Many companies have mirrored CPV and APR reporting processes. Few have realized the efficiencies of integrating them. 

  • wNMR: Spectroscopy From Biomanufacturing to Point-Of-Care

    Biomolecular NMR spectroscopy work requires highly trained personnel. Sample preparation can be laborious, as biomolecules often require isotopic labeling/enrichment. High-field NMR spectroscopy isn't well suited for manufacturing plants or clinics. Enter wNMR, a noninvasive analytical technology that operates in settings where others are ill suited. 

  • EPCIS Implementation: 4 Takeaways, Next Steps For DSCSA Compliance

    With the Nov. 27, 2023, DSCSA deadline quickly approaching, the HDA Research Foundation recently released a survey to assess how the industry is preparing. This article summarizes the 4 key takeaways as well as your next steps for DSCSA compliance.

  • Method-of-Treatment Patents: Increasing Value & Risk

    Patents on methods-of-treatment using pharmaceuticals are being asserted in broad ways against a variety of parties, with potential liabilities of hundreds of millions of dollars. Method patents can be obtained not only for new indications but also for other discoveries made after the initial approval, like dosing regimens. 





In this short Bioprocess Online e-book, we’ve gathered wisdom and foundational advice on QMS execution from contributing Expert Network team members Tobias Kuners of Koenders (Tob Management) and Grant Mordue (Pro-Active GMP Consulting Ltd.), in addition to insight from contributor James Rolston (KPMG).

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