Navigating the shifting sands of filtering facepiece respirator provision during the COVID-19 pandemic: a system response for maximising staff safety.

Introduction: Personal protective equipment is essential to protect health workers and patients and to ensure confidence when dealing with aerosolised disease transmission. We describe the process for ensuring adequate filtering facepiece respirator (FFR) qualitative fit testing at a local level during the COVID-19 pandemic.

Methods: Cascaded training is described, which allowed rapid spreading of the testing process, with supervision allowing quality assurance throughout.

Towards a common framework for defining ancillary material quality across the development spectrum.

Ancillary materials (AMs) play a critical role in the manufacture of cell and gene therapies, and best practices for their quality management are the subject of ongoing discussion. Given that the final product cannot be sterilized, AM quality becomes increasingly critical to the clinical advancement of cell and gene therapies. Despite a lack of direct legislative direction regarding AM quality, internationally harmonized guidance is available from several industry-standard bodies that describe the principles and application of a risk-based approach to AM qualification and related supply-chain risk management.

Bioprocessing automation in cell therapy manufacturing: Outcomes of special interest group automation workshop.

Phacilitate held a Special Interest Group workshop event in Edinburgh, UK, in May 2017. The event brought together leading stakeholders in the cell therapy bioprocessing field to identify present and future challenges and propose potential solutions to automation in cell therapy bioprocessing. Here, we review and summarize discussions from the event.