Visible particles Within CGT
This team will develop a holistic and strategic approach to reduce and de-risk the presence of visible particulates in CGT drug product formulations. This approach focuses on characterization and detection of inherent and intrinsic particulates associated with the drug product manufacturing process and formulation. Once particles are characterized and sources identified, improvements in material quality and process controls will reduce the number of particulates.
CGT products are unable to have a drug product essentially free from visible particles. Due to the nature of the product, some visible particles are expected.
Current pharmacopeia guidance (USP<1790>, USP<790>, Ph. Eur. 2.9.20, Ph Eur. 5.17.2) is focused on visible particles in sterile parenteral dosage forms and “Parenteral preparations are essentially free from visible particulates.” This guidance is not directly applicable to cell and gene therapies (CGT), which are uniquely characterized by their cellular content, low batch volumes and inability to sterile filter to drug product formulation/fill. Partciles are therefore exepcted.
Identifying, characterizing and de-risking visible particles in CGT products.
A harmonized approach to how the CGT industry manages visible particles will result in reduced risk of quality/regulatory non-compliance and reduced risk of regulatory delay.
Visible particles Within CGT deliverables
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