GUEST COLUMNISTS

  • Merck’s 2 Lessons Learned In Overcoming Single-Use Materials Supply Challenges

    The COVID-19 pandemic has caused severe disruption to supply chains, making it difficult to get material. At Merck, a situation occurred recently wherein they were unable to get the filter assembly they needed, and their supplier was struggling to meet demand. This article shares Merck's two lessons learned from the experience.

  • 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.

  • Congressional Bill Supports 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.

  • 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.

  • How AstraZeneca Optimized Vapor Phase Hydrogen Peroxide Gassing Cycle Development

    Demonstration of efficacious decontamination is a critical aspect of aseptic processing and sterility testing. By adopting enzyme indicators in the cycle development phases, greater understanding of efficacy of the gassing process can be achieved by providing quantitative results in a faster time frame. Here's how AstraZeneca did it.

BIOSIMILAR WHITE PAPERS

  • Cost Analysis, Evaluation Of Perfused Seed Train Scenarios
    6/17/2020

    A description of process modeling and comparison of process economics of a conventional upstream process versus three perfused seed train alternatives in conventional and high-seed fed-batch bioreactors. 

  • Facilitating 21 CFR Part 11 Compliance With Bio4C Orchestrator
    8/16/2021

    How Bio4C Orchestrator Software provides technology to support requirements for electronic records and provides a detailed “rule-by-rule” analysis for 21 CFR Part 11 and Annex 11 in tabular form.

  • User Experience For Manual Injection Of 2 mL Viscous Solutions Is Enhanced By A New Prefillable Syringe
    9/17/2020

    Although subcutaneous administration improves patient compliance and quality of life by enabling at-home injections, as compared to intravenous or intramuscular route, the associated anxiety, pain, discomfort, and the frequency of injections can play a significant role in patient non-adherence with chronic subcutaneous treatments. In order to address these challenges, through reducing the required frequency of subcutaneous injections and increasing injection comfort for novel biotherapeutics, drug delivery systems are needed to enable the administration of large-volume injections and/or high-viscosity drugs. We developed a pre-fillable glass syringe featuring a stacked 8 mm needle with an ultra-thin wall (UTW) cannula technology as a solution.

  • Three Options To Viral Vector Manufacturing Capacity
    9/1/2020

    A recent Virtual Think Tank focused on the challenges and trends influencing design considerations for viral vector manufacturing facilities, and how they can impact companies developing cell and gene therapies.

  • Getting Your Investigational Drug Regulatory Ready
    12/1/2020

    Here, we map out basic information to help you approach regulatory policies and offer helpful strategies to facilitate efficient regulatory review and drug approval.

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BIOSIMILAR DEVELOPMENT CONTENT COLLECTIONS

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The debate over whether the biosimilar regulatory paradigm can shift away from comparative efficacy trials has intensified over the past few years. This collection of articles serves as a snapshot of the many different components of this ongoing discussion.

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