Faecal microbiota transplant (FMT) therapy is mainly used for the treatment of recurrent Clostridioides difficile infection (rCDI) associated with diarrhoea and pseudomembranous colitis. FMT also appears effective in the treatment of other inflammatory bowel diseases and there is now a great deal of research being undertaken to define the key components of the faecal microbiota responsible for its therapeutic effect.
Such research is driving the transition from a poorly characterised faecal microbial consortium to a more defined, stable product, suitable for long term storage and containing rationally selected bacterial strains to target specific pathological conditions.
Strict environmental requirements, eg anaerobic atmosphere, for the required bacterial species are proving to be highly important during development and manufacture of defined products.
Whitley GMP Anaerobic Workstations have been developed for use in the manipulation of faecal material, microbial consortia and individual strains for the production of novel therapies. They have been specifically designed to be used as a clean-air isolator in processes following Good Manufacturing Practice (GMP).
These workstations exceed the requirements of Grade A air cleanliness (EU GMP) and ISO 14644-1 Class 3 both at rest and in operation. They combine sterile laminar airflow, positive operating pressure, and physical isolation to provide highly effective product protection. As a completely closed, re-circulating, isolator system, a Whitley GMP Workstation can be housed in a Grade D environment during GMP compliant use.
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