Science is moving faster than bioprocessing; standardized, high-volume manufacturing infrastructure no longer delivers innovations in therapeutics and emerging modalities like cell and gene therapies require custom, scalable bioprocessing solutions, said the partners.
Their tie-up combines two components necessary for the successful recovery of empty and full AAV capsids during anion-exchange (AEX) purification: the separation technology and the buffer composition.
Teknova produces critical reagents for the research, discovery, development, and commercialization of novel therapies, vaccines, and molecular diagnostics, and Sartorius BIA Separations develops monolith-based technologies for the separation and analysis of large biomolecules and viral particles.
A critical pain point targeted by the partners is one that is well-known in the AAV gene therapy bioproduction workflow - the polishing step of AAV full capsid enrichment. “The ability to reliably reproduce results and confidently identify the discreet differences in empty and full AAV particles is very challenging,” explained Bella Neufeld, director of research and development, Teknova.
Sartorius BIA Separations' AAV platform is designed to optimize the separation of viral particles, and Teknova’s buffer solutions are developed to maximize capsid enrichment.
The companies conducted a robust design of experiment (DOE) and created a screening kit with optimized buffer formulations that drive consistency and increased purity when paired with the BIA CIMmultus QA monolith.
“Through the course of our DOE, more than 100 AEX runs were conducted to determine the best buffer formulation to use in combination with the CIMmultus QA monolith. The DOE contained four parameters – pH, excipient, surfactant, and stabilizer – which were assessed using four critical quality attributes – infectivity, purity, recovery, and peak separation – to determine the optimal buffer formulations that maximize capsid enrichment,” Neufeld told BioPharma-Reporter.
The companies said they are committed to sharing and publishing the findings of their DOE using AAV2 and AAV8 serotypes. They intend to continue to generate data showing improvements in AAV purification when using their combined technologies, potentially analyzing additional serotypes or viral vector platforms.
"Both companies are presenting the findings, including all relevant data, at industry conferences in the form of posters and presentations, and we are exploring additional channels such as webinars and podcasts while we collaborate on preparing a manuscript for submission to a peer-reviewed publication," added Neufeld.
The components are available from each respective collaborator. Teknova’s AEX Buffer Screening Kit, which was developed in part due to the collaboration with Sartorius BIA Separations, is attainble through participation in its early access program. The kit is expected to be commercially available for AAV2 later this year.