Speakers

Patrick currently works as CMC project lead for the personalised plasmid DNA cancer vaccine programme at Nykode Therapeutics, located in Oslo, Norway. During his four years at Nykode (former Vaccibody), Patrick contributed to setting up and managing the supply chain for patient-specific manufacture. This also involved preparation of quality documentation and interaction with regulatory authorities to define a suitable manufacturing strategy. Prior to Nykode, Patrick was part of the analytical department at the CDMO Cobra Biologics, Södertälje, Sweden, supporting and coordinating development of protein-based drugs in pre-clinical and clinical phase for various international customers.
He holds a master’s in integrative biology from the ETH Zurich, Switzerland and PhD in medical sciences within the area of autoimmunity and T cell immunology from the Karolinska Institute in Stockholm, Sweden.

Presentation Title: Designing a Robust Manufacturing Strategy for Personalised Vaccines

Abstract: Nykode Therapeutics is developing a personalised neoantigen plasmid DNA cancer vaccine for treatment of patients with cancers of high unmet medical need. The manufacturing process from assessment of the patient’s tumour biopsy to the delivery of the respective drug requires a carefully orchestrated supply chain. The turnaround time is of vital importance as the patient is awaiting treatment with the vaccine to be manufactured. The platform based Good Manufacturing Practice (GMP) manufacturing process should be robust and streamlined to allow delivery of a batch size covering a full treatment regime. The talk will be focusing on challenges and mitigations experienced in setting up a supply chain as a small start-up company and managing patient screening versus manufacturing capacity during clinical studies.

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