GUEST COLUMNISTS

• A Short Guide On Transitioning From Monoclonal Antibody To AAV Separation Science

  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.

• Best Practices For Cell Culture Media Fingerprinting

  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. 

• Dispelling 4 Common Myths Of Data Quality Governance

  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.

• Draft FDA Labeling Guidance Proposes More Clarity For Providers

  The FDA's draft guidance for prescription and biologic drugs updates a 2010 guidance and comes following the boom of activity in the biologics space. This article breaks down and analyzes the update on labeling for prescription drugs and biologics on an increasingly complex landscape. 

• ICH Guideline Q9(R1) On QRM, Part 2: Subjectivity & Supply Continuity

  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.

• Financing For Emerging Biotechs: Recent Trends & Predictions For 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.

• ICH Guideline Q9(R1) On QRM, Part 1: Formality & Risk-based Decisions

  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.