130
Providers
2000+
Products referenced
10+
active Delivery service providers
Supply Chain
Through a partnership with French Hospital/Clinic network and global Providers, we offer an extensive array of clinical-grade materials to support your clinical development:
Cell/Tissue from healthy Donors and Patients: adipose tissue, blood, leukapheresis, bone marrow,…
Full Qualification of human sample: donor eligibility/consents, serology, sterility,…
Various immortalized Cell lines
Qualified raw material at best prices
Process and Analytical Development
GMP productions are susceptible to failure without the intelligent establishment of Critical Process Parameters and Critical Quality Attributes. It is crucial to de-risk your project.
From UpStream to DownStream Process Development, our tailored approach ensures robustness, cost-control, and time-savings to your process.
- ADHERENT and Non-ADHERENT Cell types
PRIMARY or ENGINEERED Cell line
Strong experience in CELL BIOLOGY
Our SCIENTIFIC approach combined with our REGULATORY expertise maximizes the potential for a seamless scale-up and GMP production.
1mL - 50L+
Culture volume capabilities
50+
in-house analytical assays
20+
Process Development Projects
5 & 10
class-B cleanrooms and R&D/QC labs
20+
GMP batches produced
100+
Instrumentations & Technologies
GMP Manufacturing & Cell Banking
Our experienced Production and QC Teams operate daily in a state-of-the-art facility authorized by the National French regulatory Agency (ANSM). From Technology Transfer to GMP Manufacturing, we support your projects with transparency and collaboration to find a solution to every Manufacturing challenge.
- AUTOLOGOUS & ALLOGENEIC programs
- Compliance with EMA and FDA
- Dual-language SMQ DOCUMENTATION
- TIME-saving focus
QC & Regulatory Support
Regulatory considerations are a cornerstone of your program’s success, do not underestimate it.
Our highly skilled Quality Assurance (QA) team, backed by a robust Quality Management System (QMS), has all the required procedures for CELL BANKING, DRUG SUBSTANCE batch release, and DRUG PRODUCT batch certification for clinical trial use.
Combined with stringent QC PROCEDURES, you will obtain a complete control and traceability throughout the Manufacturing and Release of your Cell-based product.
Our processes align with EMA and FDA compliance standards
10+
QC Technicians & Engineers
20+
IMPD co-writing
500+
SMQ Documentations
10+
French Hospitals
1000+
patients identified for multiple therapeutic indications
Patient Access
With the continuous rise in clinical trials within immune-oncology, regenerative medicine and autoimmunity, gaining access to patients has become both expensive and time-consuming. Sharing your passion for bringing advanced therapies to market, we’ve invested in cultivating relationships with over 10 hospitals, facilitating streamlined access to 10,000+ patients.
This commitment is not only vital for the success of your programs but also for the well-being and success of the patients themselves.
