Services
Core service pillars
Advanced training in formulation development of biotech molecules
Trainings are based on combination of literature knowledge and experienced-based case studies. They can address different biotech entities such as monoclonal antibodies, multi-specific antibodies, antibody-drug conjugates, or nucleic acid therapeutics. Customized training can be tailored to client needs.
- Mechanisms triggering instability of the development candidate
- The four pillars of chemical, structural, colloidal and interfacial degradation
- Stress factors and risks during the lifetime of biotech entities
- How to build a preformulation and formulation approach that mitigates instability risk
Strategic consulting and advisory on CMC development of biotech molecules and drug delivery systems
Will be customized to the specific biotech entity : monoclonal antibodies, multi-specific antibodies, antibody-drug conjugates, or nucleic acid therapeutics. This service is particularly relevant to companies using nanodrug delivery systems such as lipid nanoparticles.
- Building a CMC development strategy, define bottle necks and main risks of delays or failure
- Anticipation and synchronization of the CMC development workstreams (DS, DP and Analytical)
- Identifying and partnering with CMOs/CDMOs adapted to your portfolio need
- How to build reliable CMC dossiers for clinical and commercial registration
- Management of CMC development acceleration during clinical development
Other services
- Troubleshooting and root-cause analysis during CMC development
- CMC risks assessment
- Lead, organize or contribute to CMC scientific advisory boards
- CMC due diligences
Define the problem and find the adequate solution to it, rather than buy solutions and look for the problem.
Fields of Expertise
CMC development strategy from entry into development to registration.
Formulation and process development of proteins, monoclonal antibodies, antibody-drug conjugates, multi-specific formats.
Formulation and process development of nucleic acids, DNA, mRNA, small RNAs.
Nanodrug delivery of biotech entities.
Conception and development of lipid nanoparticles.
Who We Serve
Scientists, group leaders, transversal leaders or scientific decision makers exposed to the specific challenges brought by new and complex biotech entities.
Training is mostly targeting scientists from CMC departments involved in formulation development, analytical development, process development, or industrial transfer.
Services can also be proposed to associates from CMC project management, dossier preparation, quality, regulatory, or device development.
Biotech start-ups and small companies at early to late clinical development stage.
Pharmaceutical companies needing independent advice.