GUEST COLUMNISTS

  • Make This Your New EU IDMP Implementation Strategy

    Just when the life sciences industry was as sure as it could be that EU Iteration 1 of ISO Identification of Medicinal Products (IDMP) implementation for centralized procedures in Europe was ready to go, the EMA announced a change of plan. Until further notice, the Digital Application Dataset Integration (DADI) user interface will be used to enable structured data submissions.

  • Key Considerations For Decarbonizing Your Biotech Facility

    Biopharmaceutical manufacturing processes do not directly utilize fossil fuels, but fossil fuels are used in the generation of raw materials, consumables, packaging, and in supplying energy to building systems and manufacturing equipment. This article looks at key facility decarbonizing considerations using a case study with quantification of estimated costs.

  • 3 Keys To A Fit-For-Purpose Compliance Strategy In Decentralized Pharma

    Outsourcing and technology have morphed our industry into a new decentralized model. Now, each sponsor must carefully develop an ongoing compliance strategy considering its unique business model and its influence on the drug development journey. Strategies are needed to design QMS' that can expand and pivot in tandem with corporate and clinical development.

  • The Single-use Bioprocessing Bottleneck & Looking Ahead

    Are you asking, What happened to the bags promised for my product? The single-use system bag market had been seeing strains as early as 2018, and COVID-19 made the demand worse. This article looks into the factors contributing to the demand. Normalization of the supply chain may continue to be delayed, but it will eventually even out.

  • Technical Due Diligence Considerations For Multi-Site Biopharma Acquisitions

    Part 1 of this 2-part article series shared considerations for standalone biopharma manufacturing facility acquisitions. This article, Part 2, shares considerations for multi-site acquisitions when the seller is manufacturing part or all its products in-house.

  • Tech Due Diligence: Acquiring A Biopharma Manufacturing Facility

    As a consultant, this author has been approached on several occasions to perform on-site technical due diligence for facilities that his clients were considering to acquire. In this article, he shares the considerations you should keep in mind when acquiring a stand-alone biopharma manufacturing facility.

  • A Better Path For CMO Relationships As The Pandemic Continues

    In this article, we discuss how drug sponsors and service providers can better work together to continue down the path of outsourcing success that has been highlighted during the pandemic.

BIOSIMILAR WHITE PAPERS

  • Strategies For Upstream Intensification

    Upstream intensification is one strategy that will enable the Facility Of The Future by significantly driving down costs through an increase in volumetric productivity. Read the white paper to learn more!

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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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