Genosafe

#Biomanufacturing / Pharmaceutical Services #Therapeutics

• Advanced-therapy medicinal products (MTI-ATMP)
• Gene therapy
• Cell therapy
• Vaccination

BACKGROUND
GenoSafe was incorporated in 2003 and became operational in 2004. Its two shareholders are Genethon and the French Muscular Dystrophy Association (AFMTelethon).
DESCRIPTION OF THE PRODUCTS / SERVICES / TECHNOLOGY
From the research phase through to the clinic, GenoSafe offers true project support in study design, analytical development and product testing in three main areas:

• Preclinical studies (including biodistribution studies for gene transfer products).
• Quality control of gene and cell therapy products for preclinical and clinical use.
• Clinical Development: Follow-up of patients included in clinical trials.
• Customized regulatory advice for the development, manufacturing and control of ATMPs.

CUSTOMER REFERENCES / COLLABORATIONS / HIGHLIGHTS

• GenoSafe’s European and North-American clientele is composed of biotech firms, pharmaceutical companies and academic labs.
• GenoSafe is a SME partner in various French and European collaborative projects.
• In compliance with GLP and GCP regulations.

COLLABORATIONS SOUGHT
Clients seeking a CRO to assess the safety, quality and efficacy of their biotherapeutic products, responding to their expectations in terms of Quality of Services (scientific and regulatory) and meeting timelines.

• Further information

  Annual turnover: €5.2M
  34 staff members
  Strengths:
  scientific expertise in complementary fields (molecular biology, immunology, cell culture, virology), customized services, flexibility, ability to meet timelines, GLP and GCP compliance facilities: BSL1, BSL2 and BSL3 labs.
  Innovation assets:
  Customer support from the research phases through to the clinic.

  Other facts:

  The financial situation of Genosafe has been rated “H3” (strong) by the Banque de France.