February 4, 2022 -- Mission Bio has completed the first tech transfer of a clinical trial-, good manufacturing practices (GMP)-ready cell and gene therapy (CGT) assay from its Tapestri platform to Avance Biosciences, to assess transduction efficiency for an autologous cell therapy currently under development.
The collaboration marks the first time the Tapestri platform will undergo qualification and validation within a GMP setting, paving the way for its use in clinical trials on CGT materials to support the next wave of lifesaving CGT treatments.
The Tapestri platform will allow Avance to analyze cells that have been transduced with lentivirus, identifying transgene integration within individual cells without the need to grow clonal populations, according to a press release from Machine Bio.
Before Tapestri, workflows required synchronizing data from multiple genotypic and phenotypic assays over several weeks, an approach with reduced specificity and limited ability to characterize cells with simultaneous edits.
Tapestri assays are already used in preclinical settings to assess critical quality attributes of CGT candidates in a GMP environment. This validates its utility at the clinical and chemistry, manufacturing, and control phases, said Mission Bio. With GMP compliance, Tapestri can be used for batch release assays to assess products prior to administration to patients.
No financial details of the collaboration were disclosed.
Mission Bio is a life sciences company that accelerates discoveries and cures for a range of diseases by equipping researchers with the tools they need to better measure and predict human resistance and response to new therapies. Avance Biosciences is a contract research organization that specializes in biological assays to support the biopharma industry.
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