Date: 2015-12-01
Type of information: Validation of a production plant
Compound: facility located in Milan
Company: Molmed (Italy)
Therapeutic area: Rare diseases - Genetic diseases
Type agreement: validation of a production plant
Action mechanism:
Disease:
Details:
- • On December 1, 2015, MolMed announced that AIFA (Agenzia Italiana del Farmaco) granted the operating facility located in Milan, via Olgettina, 58 (at the San Raffaele Biotechnology Department - DIBIT), authorization to manufacture medicinal products to be marketed. This authorization is valid for manufacturing of medicinal products used in a specific gene therapy based on genetically modified stem cells, and in a specific cell therapy based on immune system genetic engineering, and could become operational following the outcome of the respective marketing authorization applications already submitted to EMA (European Medicines Agency).
- This authorization confirms MolMed’s technical-scientific and industrial quality standard in the field of gene and
cell therapies, and couples with the renewal of the one granted to the same facility for manufacturing of medicinal products for investigational purposes. In fact, the production site located at DIBIT is an AIFA qualified Officina Farmaceutica since 2003, and is compliant with the best practices governing manufacturing of patient specific genetically engineered cells, and active pharmaceutical ingredients for clinical use.
- In 2013, MolMed started an important project aimed at expanding its production capacity at the scientific park “Open Zone” in Bresso (Milan). Once completed MolMed will have an additional fully compliant facility, meeting the same quality standards and technological expertise already endorsed at the manufacturing site located at DIBIT.
Financial terms:
Latest news:
Is general: Yes
