Electrophilic and other reactive compounds, and their precursors, must be measured and removed to ensure patient safety.

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Measuring and Removing Genotoxic Impurities

As the biotech industry evolves, there are mounting concerns about the transportation, security, and robustness of cell-culture media, intermediate, or bulk drug substance (BDS). Safe, stable, and closed systems are needed when sterile products are shipped in single-use bags. In this article, the authors look at the limitations of the validation for a single-use shipping system and provide a perspective on what shipping validation means.

In this article, the authors look at the limitations of the validation for a single-use shipping system and provide a perspective on what shipping validation means.

Qualification and Validation of Single-Use Shipping Systems

Flexibility now guides cleanroom design and plant construction. This article examines the changes now taking place, and what the future might bring.

This article examines the changes now taking place, and what the future might bring.

The Evolution of Planning, Design, and Engineering—Flexibility Takes Center Stage

Revised versions of ISO 14644 Parts 1 and 2 introduce changes to sampling procedures and monitoring plans for cleanrooms and clean zones.

Revised ISO Cleanroom Standards Improve Air Cleanliness Classification

Collaboration and single-use technologies aided the rapid scale-up of Ebola vaccine manufacturing. 

Collaboration and single-use technologies aided the rapid scale-up of Ebola vaccine manufacturing

Lessons Learned Accelerate Vaccine Development

Intact enables aseptic filling in non-classified environments, maintains sterility throughout the process, and reduces costs, timelines, and contamination risks.

Protecting the Product and the Patient

Erring on the side of safety is a well-established way of ensuring patient safety, but it may now be getting out of hand, as product recalls and withdrawls deprive patients of necessary treatments without the surety that recalled product would have caused any harm to the patient. 

Deconstructing the Regulatory Spiral

USP requirements for the absence of “objectionable organisms” are well intended, but may often result in the need for subjective, and unrealistic, determinations. This article discusses the issue and offers food for thought and suggestions for more science-driven approaches.

This article discusses the issue and offers food for thought and suggestions for more science-driven approaches.

Pharmaceutical Technology-05-15-2016