US FDA’s Advanced Manufacturing Designation Lifts Off With Cellares Cell Shuttle

Cellares’ fully automated cell therapy manufacturing platform is the first system to receive an Advanced Manufacturing Technology designation from US FDA

Cellares hopes its Cell Shuttle will ride an Advanced Manufacturing Technology designation to new corporate heights (Shutterstock)
Key Takeaways
  • Cellares’ Cell Shuttle, an automated manufacturing platform for cell therapy, is the first system to receive an Advanced Manufacturing Technology designation from the FDA

Cellares became the first company to announce receipt of an Advanced Manufacturing Technology designation from the US FDA on 1...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Platform Technologies

UK’s Decentralized Manufacturing Rules Designed To Allow For ‘Future Developments’

 

The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.

Elevidys Helps Sarepta To First US FDA Platform Technology Designation

 

Sarepta's rAAVrh74 vector, used in the marketed Duchenne muscular dystrophy gene therapy Elevidys and across the company's limb girdle muscular dystrophy pipeline, earned a platform designation as the lead LGMD candidate prepares for BLA filing.

US FDA’s Advanced Manufacturing Designation Lifts Off With Cellares Cell Shuttle

 

Cellares’ fully automated cell therapy manufacturing platform is the first system to receive an Advanced Manufacturing Technology designation from US FDA

UK MHRA Consults On The Way For Personalized mRNA Cancer Therapies

 

The UK’s drug regulator is developing a “clear and streamlined” regulatory pathway for individualized cancer mRNA immunotherapies.

More from Compliance

EU Pharma Overhaul May Reshape Aspects Of Drug Promotion And HCP Partnerships

 

Lawyers explain how changes to rules around drug advertising and promotional activities under the EU pharma reform package could impact companies operating in the bloc, with one legal expert advising companies to “monitor developments closely.”

US FDA’s Tough Talk On Talc: Regulating In An Echo Chamber

 

An FDA “expert roundtable” on talc produced a new talking point on a potential drug safety risk, but the basis of that claim is difficult to determine.

BIO CEO On Industry And US FDA, Trump’s Vaccine Views And MFN Counter Proposals

 

John Crowley discussed how he prioritizes industry’s many competing challenges in a Pink Sheet interview at the BIO International Convention.