Date: 2018-06-21
Type of information: Validation of a production plant
Compound:
Company: MeiraGTx (USA - NY)
Therapeutic area: Rare diseases - Genetic diseases
Type agreement: validation of a production plant
Action mechanism:
Disease:
Details:
- • On June 21, 2018, MeiraGTx announced it has been granted a Manufacturer’s Authorization for Investigational Medicinal Products from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA). The license allows MeiraGTx to manufacture gene therapy product candidates in their current Good Manufacturing Practices (cGMP) compliant manufacturing facility.
- Completed in early 2018, MeiraGTx’s 29,000 square-foot facility located in central London was designed to operate as a flexible and scalable manufacturing hub, housing two cell production suites and three separate viral vector production suites, offering production of multiple product candidates in parallel, as well as sequentially at different scales.
- The facility also incorporates an integrated analytical department, an in-house analytical tool kit, and a dedicated product fill-and-finish suite. MeiraGTx’s facility has been designed to meet MHRA, EMA and FDA regulatory standards.
Financial terms:
Latest news:
Is general: Yes
