Guest Columns

  1. New US Legislation Creates Momentum For Biosimilars 6/25/2021

    Most biosimilars (follow-on biologic products) still only have shares below 50% in the U.S., which is far different than market shares in Europe. One major reason is a mistrust around biosimilars’ safety and efficacy. Congress has stepped in to address that issue through the Advancing Education on Biosimilars Act of 2021, with the goal of encouraging rapid uptake soon after biosimilars become commercially available.

  2. Data Integrity In Supply Chain Risk Management During Zero Trust 6/21/2021

    Due to the pandemic, we have had to reconsider our approaches to supply chain risk management and to develop new and creative risk management strategies and tactics in response. This article examines how data integrity principles mitigate ALCOA concerns during this period of zero trust.

  3. Peptides: Best Practices On Regulatory & Control Strategies, Analytical Methods, & More 6/18/2021

    Industry, regulatory, and academic experts recently gathered at the United States Pharmacopeial Convention’s (USP’s) annual Peptides & Oligonucleotides Workshop virtually to share best practices on chemistry, manufacturing, and controls (CMC) for peptides. This article summarizes discussion highlights.

  4. The “Resiliency Roadmap” — Next Steps For FDA Inspections 6/11/2021

    More than a year into the COVID-19 pandemic and FDA’s abrupt suspension of on-site inspections in March 2020, the agency released the Resiliency Roadmap for FDA Inspectional Oversight in May 2021. This article examines how this news affects the pharmaceutical, biotech, and medical device industries.

  5. Patenting Antibodies: The 4 Tactics To Use In 2021 6/4/2021

    With epitope claims less available post-Amgen v. Sanofi, this article examines four useful approaches that you and your antibody patent lawyer can implement in order to improve your chances of obtaining valid antibody claims with functional attributes.

  6. What Do Artificial Intelligence And Continuous Validation Have In Common? 6/2/2021

    Validation documentation can be reduced by applying automated testing and deployment. This article discusses ISO standards that address risk management, IT alignment with software engineering, opportunities for continuous lifecycle management, and how artificial intelligence (AI) can help.

  7. Outlook: Biotech In 2021 & Beyond 5/31/2021

    Biopharma companies have responded in an astounding manner to the COVID-19 pandemic through vaccines, therapies, diagnostics, and variant tracking. For those efforts, the industry is seeing some amazing investor awareness, political support, and increased public perception. This article focuses on the U.S., but also includes some worldwide numbers.

  8. Statistical Methods For Comparing Small-Scale Models To At-Scale Biopharmaceutical Manufacturing 5/26/2021

    As the final article in a three-part series that summarizes the discussions and exchanges of a BioPhorum Development Group workstream on small-scale model (SSM) justification, this article discusses statistical methods for comparing SSM outputs to at-scale outputs and covers descriptive statistical methods, inferential methods, difference tests, equivalence tests, and more. 

  9. Planning & Executing Small-Scale Model Qualification For Upstream & Downstream Biopharma Processing 5/19/2021

    As the second article in a three-part series that summarizes the discussions and exchanges of a BioPhorum Development Group workstream on small-scale model (SSM) justification, this article covers the current opinion on how to execute small-scale model qualification for both upstream and downstream SSMs and analytical setup. 

  10. Implementing Small-Scale Models For Biopharmaceutical Development 5/12/2021

    Small-scale models (SSMs) are widely used for process development and optimization, scale-up, technology transfer, process characterization, process validation, and more. This article from a BioPhorum Development Group discusses the applications of the models, including viral clearance, quality oversight, and design considerations for justification of SSMs.