ARTICLES BY BIOPHORUM
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![teamwork, celebration, success, achievement-GettyImages-2215022093]( "Improving Drug-Device Combination Product Co-Development")
Improving Drug-Device Combination Product Co-Development8/8/2025Early recognition and mitigation of drug and device integration difficulties are critical to the success of combination products. The collaborative effort in development cannot be overstated.
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![covid vaccine coronavirus-GettyImages-1263021678]( "A Holistic Approach To Container Closure Integrity")
A Holistic Approach To Container Closure Integrity5/20/2024Regulations are pushing for an approach to container closure integrity that builds quality into the design and processes rather than testing/inspecting the manufactured item.
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![iStock-154932811-e1593532182605_biophorum]( "Container Closure Integrity Testing Strategies For Gene Therapies")
Container Closure Integrity Testing Strategies For Gene Therapies6/7/2023Container closure integrity testing (CCIT) has been recognized as having a significant impact on batch yield. This article provides perspectives on CCIT strategies to minimize the impact on gene therapy drug product batch yield by examining recent industry survey results as well as best practices.
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![Vaccine injectable vials and syringe GettyImages-1252804942]( "A Methodology To Support Particle Investigations In Biopharma Products")
A Methodology To Support Particle Investigations In Biopharma Products11/22/2022Particles in parenteral products are a major cause of product recalls, and appropriate management of risk from visible particles is vital. This standardized methodology provides users with a decision-making tool to clarify the risks presented by a particle to a batch.
