Preclinical CRO Capacity Expansion
WEST JEFFERSON, Ohio, November 10, 2022 (Newswire.com) – AmplifyBio, a contract research organization that is building an ecosystem for the advancement of advanced therapies, today announced the completion of initiatives to expand capacity and reduce timelines for the execution of preclinical CRO services. The projects, which took a little over a year to complete, involved talent recruitment, vivarium modifications, supply chain management, and data technology solutions to remove the obstacles that commonly delay preclinical research.
The first critical initiative was to increase staffing across all functional areas within the vivarium. Since its launch in 2021, AmplifyBio has grown from 125 to 265 employees within the West Jefferson, Ohio, location. As part of the expansion, five Ph.D.-level study directors have been added, with depth in neurology, toxicology, and GLP analytics for cell and gene therapies. The addition solidifies AmplifyBio’s commitment to limit the number of studies per director to maintain the optimal level of communication that advanced therapy clients require to make safety decisions efficiently.
The other steps relate to maximizing vivarium capacity by ensuring all AmplifyBio’s West Jefferson campus vivarium rooms are versatile-use spaces. Appropriate renovations were made to ensure that more rooms are equipped for NHP studies, increasing capacity for those studies by 37%. Moving away from single-purpose rooms allowed AmplifyBio to add animal housing, testing, and quarantine space and ensure the supply of all animal models is ready for starts with shorter lead times.
All the capacity-increasing solutions are run through a custom-built data module through Power BI to give a real-time view of room use and study execution activities throughout the building. That tool, built as part of AmplifyBio’s more comprehensive data democratization efforts, eliminates time lags between the room and other resource uses to shorten client lead times.
“The scientific and regulatory landscape around developing novel therapeutics is shifting rapidly. We are continuously designing studies that require us to examine new dose routes, modify in vivo models, or incorporate analytic assays. Adding diverse expertise and ensuring all our vivarium rooms are versatile puts us in a much better position to deliver studies in the timelines our clients require.” – Jerry Hacker, EVP and Chief Commercial Officer.
AmplifyBio was spun out in 2021 from Battelle, a not-for-profit organization that advances science and technology to have the most significant impact on our society and economy. They recently added a South San Francisco facility specializing in discovery, optimization, and characterization services for advanced therapies. AmplifyBio plans to add a third site in New Albany, Ohio, consisting of 350,000 square feet of multi-function lab spaces. AmplifyBio will build on its advanced therapy services by adding capabilities for complex genotypic and phenotypic characterization analysis for late-stage development. The company expects to add additional development platforms and partnerships to become a commercial accelerator delivering safe, effective, reproducible advanced therapies to patients.