Cellares has received the US Food and Drug Administration’s (FDA) Advanced Manufacturing Technology (AMT) designation for its Cell Shuttle technology.
The AMT designation, granted by the FDA’s Center for Biologics Evaluation and Research (CBER), aims to promote the technologies that improve cell therapies.
The designation highlights the company’s ability to automate and reliably produce cell therapies, representing a significant advancement in the manufacturing of these therapies.
It allows developers using Cellares’ Integrated Development and Manufacturing Organization (IDMO) services to benefit from expedited FDA reviews
Also, the designation will help the developers reduce the time to Investigational New Drug (IND) and Biologics License Application (BLA) approvals.
Cellares CEO and co-founder Fabian Gerlinghaus said: “The AMT designation for our Cell Shuttle is a testament to its potential to transform patient outcomes by delivering scalable and cost-effective cell therapy manufacturing to small, early-stage biotechs and large pharma companies with commercialized cell therapies.
“This designation now gives cell therapy developers leveraging Cellares IDMO manufacturing services prioritized FDA review, which has the potential to shorten development times, making these therapies available to more patients faster.”
The Cell Shuttle is an automated cell therapy manufacturing technique, integrating cell enrichment, selection, transduction, transfection, activation, expansion, and formulation.
It consistently meets all in-process and final product specifications, demonstrating its ability to produce high-quality therapeutic products at scale.
Cellares is the first Integrated Development and Manufacturing Organisation (IDMO) that employs an Industry 4.0 approach to mass manufacture cell therapies.
The company is establishing IDMO Smart Factories in Europe, Japan, and the US, providing global cell therapy manufacturing services.
The facilities support early clinical development and can scale to industrial-level manufacturing, achieving economies of scale even with low production volumes.
Cellares quality vice president Eric Fulmer said: “The FDA’s AMT designation for the Cell Shuttle validates Cellares’ Quality-by-Design methodology and provides therapy developers an expedited regulatory pathway.
“By automating cell therapy manufacturing on the Cell Shuttle, our clients will have a streamlined and cost-effective pathway from clinical development to commercial manufacture, ultimately accelerating patient access to these critical therapies.”
