ARTICLES BY BIOPHORUM

• A Holistic Approach To Container Closure Integrity

  5/20/2024

  Regulations are pushing for an approach to container closure integrity that builds quality into the design and processes rather than testing/inspecting the manufactured item.

• Container Closure Integrity Testing Strategies For Gene Therapies

  6/7/2023

  Container 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.

• A Methodology To Support Particle Investigations In Biopharma Products

  11/22/2022

  Particles 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.