Almac’s Scotland-based high throughput good manufacturing practice (GMP) peptide manufacturing facility has been registered with the Medicines and Healthcare products Regulatory Agency (MHRA).
The facility manufactures neoantigen-derived peptides for use in patient-specific, individualized cancer vaccine production.
To date, the global contract development and manufacturing organization (CDMO) has manufactured several batches of the peptides for compassionate use treatments and for principal investigator-initiated (P-I) clinical trials.
Over the past ten months, the facility has been upgraded to enable GMP supply, according to the company.
Alastair Hay, account manager, peptides, Almac Sciences, told us the company decided to launch the service following “requests from numerous parties over the last few years regarding requirement for high throughput peptide manufacture for use in individualized cancer vaccines.”
“The manufacturing requirements are very different from conventional peptide manufacturing, meaning there is a significant barrier to entry,” Hay said, commenting that update has been excellent.
"Personalized cancer vaccines are seen as a way to revitalize the cancer vaccine field which has stuttered over the last 10-15 years," he explained.
“There are a multitude of approaches to creating an effective individualized vaccine, and each sponsor is adopting a slightly different approach to neoepitope identification, vaccine formulation and clinical study, often with various combination therapies. Peptides are at the core of many vaccine platforms and so there is significant demand for rapid peptide manufacture to meet the requirements of ongoing clinical trials.”
GMP supply is expected to launch in the third quarter of 2018.