Guest Columns

  1. How Can Life Sciences Navigate M&A In 2023? 3/21/2023

    As we close out the first quarter of 2023, let's take a look at how life sciences executives can conduct better M&A deals despite this unpredictable business environment.

  2. A Short Guide On Transitioning From Monoclonal Antibody To AAV Separation Science 3/16/2023

    Separation scientists jumping from mAbs to AAV inherently have advantages, but familiarity can also present roadblocks. Here are a few tips on leveraging past experience with mAbs when developing AAV gene therapy products.

  3. Best Practices For Cell Culture Media Fingerprinting 3/13/2023

    This three-tier approach to cell culture media fingerprinting helps you to define an alternative method that will allow verification of the quality of the medium as well as fingerprinting. It helps you to choose suitable methods for incoming ID testing based on raw material properties, goals of media characterization, and the resources available. 

  4. Dispelling 4 Common Myths Of Data Quality Governance 3/9/2023

    Achieving robust data quality governance doesn't need to be an unwieldy prospect. Here, we dispel the four common myths of data quality governance and share the three phases of a good data quality governance program.

  5. Draft FDA Labeling Guidance Proposes More Clarity For Providers 3/7/2023

    The FDA's draft guidance for prescription and biologic drugs updates a 2010 guidance and comes following the boom of activity in the biologics space.

  6. ICH Guideline Q9(R1) On QRM, Part 2: Subjectivity & Supply Continuity 3/7/2023

    The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management, Q9(R1), was adopted on January 18. This article focuses on the guidance's new topics of subjectivity and the role of QRM in addressing product availability risks.

  7. Financing For Emerging Biotechs: Recent Trends & Predictions For 2023 3/6/2023

    After a stellar 2020 and 2021, overall early-stage financing for small and midsize biotechs declined significantly in 2022 due to a range of factors. Ernst & Young provides insights into those factors and trends, as well as the key focus areas for biotechs in 2023.

  8. ICH Guideline Q9(R1) On QRM, Part 1: Formality & Risk-based Decisions 2/28/2023

    The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management (QRM), Q9(R1), was adopted on Jan. 18, 2023. While the primary principles of QRM in this new version remain consistent with the original 2005 document, the revised guidance has four new subsections. This article examines the topics of formality and risk-based decisions.

  9. Strategic Procurement For Emerging Pharmas & Biotechs 2/27/2023

    Emerging pharma and biotech companies depend significantly on suppliers, from initial discovery to clinical trials and regulatory approval. As a result, the sourcing and procurement function requires a strategic mindset aligned with business goals to drive an efficient purchasing process throughout the entire supply chain.

  10. Biotech’s Market Outlook In 2023 & Beyond 2/23/2023

    This article discusses three key themes in 2023 that are likely to have an outsized impact on biotech companies as well as the notable longer-term trends to watch over the next few years.