Date: 2017-06-07
Type of information: Opening of new premises
Compound: commercial manufacturing facility in Clearwater
Company: Aimmune Therapeutics (USA - CA) previously Allergen Research Corporation (ARC)
Therapeutic area: Allergic diseases
Type agreement: opening of new premises
Action mechanism:
Disease:
Details:
- • On June 7, 2017, Aimmune Therapeutics hosted a ribbon-cutting ceremony to celebrate the completion of its commercial manufacturing facility in Clearwater, Florida. The facility will produce AR101, Aimmune’s investigational biologic oral immunotherapy for desensitization of patients with peanut allergy, which is currently in Phase 3 clinical studies.
- The new manufacturing facility contains more than 20,000 square feet of space and will handle full-scale cGMP commercial production of AR101 in anticipation of potential regulatory approvals. It will also supply future clinical trials of AR101 as well as trials of future product candidates. The facility includes state-of-the-art air-handling systems and equipment, which will prevent cross contamination of allergens from one suite to another, along with controls and management systems to ensure safety and compliance with U.S. and European pharmaceutical manufacturing regulations.
- The company will now complete qualification and validation activities and scale up to full functionality, so by early 2018 the new facility will have the capacity to manufacture approximately 450 million capsules of AR101 per year.
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Is general: Yes
