General October 2019
Clinical Trials on track, CBE’s September Activity Report
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CBE has been busy over September, preparing several clients for upcoming licensing inspections and moving towards clinical trials.
Two CBE clients have undergone inspections for a new manufacturing license or to extend to their existing license. We also continue to assist several other organisations working towards new manufacturing licenses, from a major biologics clinical trial manufacturing site to a new radiopharmaceutical facility.
Alison Mew provided ongoing coordination in the development for a Phase I clinical trial of a new malaria vaccine, and the trial is on track for completion by early 2022. Alison also provided manufacturing support to a pharmaceutical start-up company that has in-licensed a novel biological orphan drug, with toxicological and clinical studies to be conducted in 2020.
Read more about our work below:
- GLP Inspection. Conducted a GLP inspection on an animal trial facility, on behalf of a client who is developing novel biological therapeutic products based on extracellular vesicles. This proof of principle trial will be conducted before the end of 2019
- Audit preparation. Support to an In-vitro diagnostic company for audit preparedness of an external audit scheduled in October
- Quality System development. Support for a start-up company developing a novel biological product
- Risk Assessment. Development of risk assessment process for a hospital based compounding facility
- Provided Sterile aseptic and Microbiology expertise and validation support to facilitate TGA license
- GMP License Extension. CBE supports a long standing client in their application for a solid dose license manufacturing license extension. The site is expecting a licensing inspection in October
- Clinical Trial GMP Gap Analysis. CBE consultants conducts a GMP gap analysis for a one of our API R&D development companies in anticipation of a TGA inspection later this year. The gap analysis revealed that the firm is well on track to achieve their license for the manufacture of Phase II clinical API materials
- Hospital Sterile Compounding Pharmacies. Reviews, consulting and monitoring activity occurred at seven different sites across Victoria and New South Wales.