Guest Columns
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Audit Readiness For Cell & Gene Therapy Companies
1/16/2025
Cell & gene therapy companies are required by regulation to qualify sites performing all the steps and methods as part of their manufacturing processes.
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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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Addressing Blind Spots In Assuring Therapeutic Equivalence
1/14/2025
The new FDA commissioner-designee's focus offers a timely opportunity to expose root causes to distinguish between "special" and "common" causes of deviation and variability in public health and regulatory oversight.
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Hear Me Out — Cell Therapy GMP Starts With The Donor
1/9/2025
Regulators also have indicated they expect allogeneic cell therapy donors to meet more rigid eligibility requirements and undergo screening.
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RNA Therapeutics As We Enter 2025: Looking Beyond The Horizon Of First-Generation Success
1/9/2025
As we enter 2025, RNA therapeutics are poised to command significant attention from industry leaders as well as emerging players.
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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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2025 Forecast For Advanced Therapies
1/8/2025
As we reflect on the lessons from 2024, it’s time to consider what 2025 may hold for the industry. Special attention is given to oligos, mRNA, cell therapies, and AAV.
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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.