Almac Group has successfully completed MHRA registration of its High Throughput GMP Peptide manufacturing facility at its Technopole campus near Edinburgh, Scotland. The facility manufactures neoantigen derived peptides for use in the production of patient specific, individualized cancer vaccines.
 
Almac Sciences has been involved in the individualized cancer vaccine field for several years and its facility and systems have been set up to enable GMP compliant manufacture and release of 20-30 GMP peptides within less than three weeks.
 
Almac has manufactured multiple High Throughput batches of neoantigen derived peptides –branded by Almac as NeoPeptides, for compassionate use treatments, and for P-I clinical trials, from its Edinburgh facility. This past year, the facility has been upgraded and segregated to enable GMP supply under a custom Pharmaceutical Quality System designed to enable high speed. The systems have been tested and have demonstrated robust performance and the ability to consistently achieve the less than three weeks peptide manufacturing target. GMP supply is expected to begin in 3Q18.
 
Dr. Charles Shields, vice president Peptides and Small Molecule API, Almac Sciences said, “Almac is very excited to be at the leading edge of this revolutionary approach to immuno-oncology. The systems and capabilities we have established are world leading, but our vision goes beyond today’s performance and we already have clear plans for how to deliver higher capacity and faster manufacturing rates.”

Neoantigen derived vaccines have become an important new strategy in oncology, harnessing the body’s own immune system to fight cancer. A patient’s tumor is biopsied and genetically sequenced to identify the epitope mutations present in the patient’s cancer. These neoepitopes are unique to that patient and their tumor. The neoepitopes are then replicated within a series of peptides – typically 10-30, which are manufactured and formulated into a patient-specific cancer vaccine. Each peptide manufacture is unique and manufacture occurs once and the product is administered to one patient.