3Biotech is a consulting and support company for drug development projects. Our benchmark activity is CMC, we support biotechs on all aspects of their development, until the end of phase 2 and transfer to Phase 3
The company has existed for more than 10 years, founded and run by Olivier Favre Bulle with a recognized track record. To date, we have worked on more than 80 projects, 8 of which are in phase 1, 3 in phase 2 and 2 in phase 3.
We support our clients from the selection of the LEAD.
We work on all types of molecules: Small molecules, antibodies, ADCs, specific Bi/Tri, cell therapy, vaccine gene therapy, etc.
How do we work?
We set up teams of experts with over 10 years’ experience in the development of innovative therapies to support our customers’ projects in close cooperation with the research teams. This close collaboration between researchers and our experts helps to secure and accelerate the transition from laboratory concept to a product that can be administered to humans.
We have an international network of CDMO/CROs.
Our solutions
- Challenges, risk assessment and crash tests
- Due diligence, gap analysis, drafting of TPP and development plan with budget, etc.
- Translational research
- Lead selection and optimisation
CMC strategy
- Identifying the most appropriate technological solutions: cell lines, manufacturing processes, analytical methods, etc.
- Select appropriate CROs / CDMOs worldwide
- Define the most cost-effective process development
- Directing and coordinating all stakeholders and ensuring that deadlines, quality and costs are met
- Schedule and control the production of clinical batches
- Clinical procurement
- Helping to draft the IMPD and IND
Regulatory strategy
A planning document that includes the regulatory requirements for a specific product
- The strategic plan for communication with regulatory bodies
- Identification of specific intended uses of the product
- A description of the process and expected timescales
- A list of risks or costs that could compromise the regulatory process
In addition to this CMC activity, we are also regularly involved in the upstream and downstream stages of biotech capital raising.
Contact
Catherine Muller, EVP Business Development
cmu@3biotech.eu
