WEST JEFFERSON, Ohio, July 12, 2022 (Newswire.com) – AmplifyBio spent the month of June commemorating the first anniversary since its spin-off from the Battelle organization. The celebration involved both employee and investor events. There was a recap of all that has been achieved and what is next in the journey to becoming a world-class preclinical CRO provider with a strategic emphasis on partnering with companies pursuing advanced therapies.
In the first year, AmplifyBio achieved the primary strategic goals of increasing capacity by 50% and adding a state-of-the-art analytics laboratory. This new laboratory further enables the scientific team at AmplifyBio to meet the growing needs of drug development clients by complementing in vivo preclinical studies with the in vitro molecular and immunological assays necessary to assess the safety and viability of advanced therapies fully.
Assessing biodistribution, gene expression, vector integration, and monitoring immune responses alongside preclinical work provide the data necessary to modify study designs, improve efficiencies, compress timelines, and reduce costs. These assays will be performed at AmplifyBio using the most up-to-date technology of digital PCR, spectral flow cytometry, live imaging, and multiplexed arrays and reported using custom data solutions to ensure actionable data is reported in real-time.
“I’m so proud of our progress since launch toward becoming the preclinical CRO of choice for traditional and advanced therapy clients alike. I could not be more excited about the next chapter where we advance the building of an environment for advanced therapy commercialization that integrates technology, platforms, operating systems, quality, and expertise, making AmplifyBio a preferred drug development partner from concept to patient,” said J. Kelly Ganjei, CEO, AmplifyBio.
In addition to building the analytics lab, AmplifyBio further sought to reduce common bottlenecks in preclinical studies. Among those improvements was the expansion of scientific staff and pathology platform technologies with investment in fluorescent microscopy, digital pathology methods, and IHC. The quality team also implemented Veeva Quality Suite to ensure clients can trust the data delivered through Amplify preclinical studies.
To address customers’ growing needs, AmplifyBio expanded staff numbers and expertise in every department, from 125 employees at launch in May of 2021 to 215+ employees today, with ambitious hiring plans continuing through 2022. The preclinical CRO also expanded study teams to ensure accurate, efficient communications and transparency to clients throughout the lifecycle of a study. As a result of these capacity and capability investments, AmplifyBio added 23 new clients since launch and increased business and study volumes with existing customers by more than 40% vs. the previous year.
As AmplifyBio looks to the year ahead, it will expand into a second site in New Albany, Ohio. That additional site will consist of 350,000 square feet of multi-function lab spaces, accessible through modular suites. There, AmplifyBio will add capabilities for complex genotypic and phenotypic characterization analysis. Over time, the preclinical CRO will add additional development platforms and partnerships to the space to achieve the vision of becoming a commercial accelerator delivering safe, effective, reproducible advanced therapies to patients.
AmplifyBio is a leading preclinical CRO focused on toxicology, safety, and pharmacology testing to advance therapeutics for the betterment of human health. Spun out of Battelle in May of 2021, AmplifyBio’s mission is to continue to provide exceptional CRO study services in an agile environment better suited to commercial goals and expand analytic capabilities to serve the dynamic needs of advanced therapy development. Clients of AmplifyBio enjoy the peace of mind that comes from decades of experience in GLP and non-GLP study design and execution, combined with rapid investment in technology, expertise, and infrastructure that together provide the critical components of a reliable, agile partnership.