Guest Columns
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Developing ADCs? Here's A Refresher On HPAPI Occupational Health Risk Mitigation
1/16/2025
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.
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New Regulatory Survey Findings: Biotech Global Market Access Challenges And Learnings
1/15/2025
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.
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A Justification For Using In-Process Controls In Place Of Cleaning Validation
1/9/2025
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.
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7 Focus Areas To Establish A Win-Win Relationship With Your CDMO
1/7/2025
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.
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Deploy AI To Become A cGMP 'Special Agent' With A License To Care
1/7/2025
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."
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11 Key Contributing Factors For Maintaining Sterility Assurance
1/6/2025
Containers and closures, depyrogenation, equipment, materials, personnel, and 7 more major factors all contribute to sterility assurance.
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ASTM International Pharmaceutical Cleaning Standards: Current Status And Future Direction
1/2/2025
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.
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Keep An Eye On These Analytical And Monitoring Trends In 2025
12/20/2024
Three experts share their thoughts on the advances and obstacles in analytical development that they're thinking about as we head into 2025.
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Can Our Current Operational Processes Survive In 2025 And Beyond?
12/19/2024
As long as operating procedure improvements are confined to a single function or sub-area, the benefits will be limited to that context. What can we do for true process improvement across our organization?
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AP Biosciences' Approach To Complex Antibody Manufacturing
12/19/2024
The bispecific developer's vice president of antibody discovery, Jhong-Jhe You, digs into the company's approach to purification and analytics.