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The company has brought a second stream of high-throughput GMP peptide manufacturing online.
Almac Group, a contract development and manufacturing organization, announced on Jan. 2, 2019 that it has brought a second stream of high-throughput good manufacturing practice (GMP) peptide manufacturing online. The facility, located in Edinburgh, Scotland, manufactures neoantigen-derived peptides for use in the production of patient-specific, individualized cancer vaccines.
The new line joins Almac’s NeoPeptides facility, which underwent a conversion from non-GMP to GMP in 2018. The facility also completed a Medicines and Healthcare Products Regulatory Agency (MHRA) inspection. According to the company, the facility focuses on minimizing the time between an initial patient biopsy and administration of vaccine. Almac has created and implemented a quality system designed to promote high-speed, GMP-compliant manufacturing. Almac stated in a press release that it released more than 80 GMP peptides in its first eight weeks of operation.
According to Almac, neoantigen-derived vaccines are individualized platforms where a “patient’s tumor is biopsied and genetically sequenced to identify the epitope mutations which are present within the patient’s cancer … The neoepitopes are then replicated within a series of peptides-typically 10–30.” The peptides are manufactured and then formulated into a patient-specific cancer vaccine and administered to the patient.
“Almac’s decision to bring a second GMP NeoPeptides manufacturing stream online so quickly after the first is a clear statement of our commitment to the field of individualized cancer vaccines. We understand this market well and intend to maintain our world leading supply position on neoantigen derived peptides. We will be announcing further expansions of our facility and our service offering in the coming months,” said Dr. Charles Shields, vice-president Peptides and Small Molecule API, in the press release.
Source: Almac Group