GUEST COLUMNISTS

• Using Simple Spreadsheet DoE To Optimize The Protein Pipeline

  Let's demystify the design of experiments approach with simple tools for implementing 2-level factorial experiments, including workbooks free to download.

• Suffering High Protein Sieving Losses? It Might Be The Buffer

  New research shows that a common buffer used during diafiltration and ultrafiltration was at the heart of sieving losses, and using an alternative dramatically improved retention.

• Developing ADCs? Here's A Refresher On HPAPI Occupational Health Risk Mitigation

  API payloads used in antibody-drug conjugates are some of the most potent substances in biopharma, so it's important to protect workers who handle them.

• New Regulatory Survey Findings: Biotech Global Market Access Challenges And Learnings

  To understand biotech companies’ evolving geographic strategies and perceptions, Arriello recently commissioned a transatlantic survey among regulatory, safety, and quality directors at small/medium biotechs, with respondents in Ireland and North America.

• A Justification For Using In-Process Controls In Place Of Cleaning Validation

  This article provides a procedure for using and cleaning shared columns and column packing equipment and using in-process controls that eliminate the need for cleaning validation.

• 7 Focus Areas To Establish A Win-Win Relationship With Your CDMO

  Working with a CDMO doesn’t always go as planned. This article outlines the factors that will impact project success and set up a “win-win” relationship.

• Deploy AI To Become A cGMP "Special Agent" With A License To Care

  Addressing systemic cGMP issues requires more than technical fixes — it demands organizational transformation. Thoughtfully applied, AI can empower professionals to become "special agents" of quality, equipped with a "license to care."