GUEST COLUMNISTS

• 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."

• 11 Key Contributing Factors For Maintaining Sterility Assurance

  Containers and closures, depyrogenation, equipment, materials, personnel, and 7 more major factors all contribute to sterility assurance.

• ASTM International Pharmaceutical Cleaning Standards: Current Status And Future Direction

  This article provides an update on the progress of the science-, risk-, and statistics-based ASTM International Cleaning Standards: published standards, work currently underway, and how you can get involved.