GUEST COLUMNISTS

• Collaborating With Academia For Drug Discovery Targeting Immune-Mediated Diseases

  Last year, Janssen Biotech and the University of Oxford established a collaboration to understand pathogenic pathways driving immune-mediated inflammatory diseases. They have been creating a cellular map of expressed genes and proteins. This article shares what the collaboration has accomplished so far.

• Biopharma Facility Modular Design & Construction: Key Considerations

  In terms of facility design, the term “modular design block” is used for “pre-engineered” or “predesigned” solutions. This approach suggests that a new facility design need not be unique but can use and leverage a pre-engineered set of component pieces. The further down the supply chain that standardized modules and components reach, the wider the benefits to the entire industry.

• A Practical Guide To Navigate The EU's Revised GMP Annex 1

  The EU's final version of the GMP Annex 1 is now published, and it's time to take action. This article shares a road map to navigate what is new and different, how to document your "known unknowns," and more. Quality risk management and a contamination control strategy will be key.

• 5 Steps To Avoid Mismanaging Biopharma Grant Funds

  You've finally received the grant you need to make your biopharma business a reality. The tough part is over, right? Not exactly. If you mismanage your funds, you could end up on the government’s naughty list.

• Replacing The MAC/MACO With The MSC: Rethinking How Cleaning Validation Limits Are Calculated

  Two of the most commonly used terms used in pharmaceutical cleaning validation are the Maximum Allowable Carryover (MAC or MACO) and the Maximum Safe Carryover (MSC). This article provides the historical development of both terms and why we should replace the MAC/MACO with the MSC.

• Attributable Data Integrity in Modern Biopharma Using ALCOA Principles

  This article is the first in a five-part series providing contemporary, practical, and useful examples of data integrity within each of the five traditional principles of ALCOA. This article centers on A: Attributable.

• A CTO’s Journey Into Continuous Biomanufacturing

  At a recent Evaluating BioPharma virtual event, moderator John Bonham-Carter asked Chris Hwang, chief technology officer at Transcenta Holding Ltd., about Chris’ journey and experiences with continuous bioprocessing thus far in his career.

• The Environmental Impact Of Biopharma Continuous Manufacturing: Part II

  Part 1 of this two-part series began to compare the environmental impact of biopharma continuous manufacturing with batch manufacturing. In this article, the author considers process efficiency, single-use technology, and facilities requirements.