Drug product development
Our Service
Avoid running into unwarranted delays and quality issues by collaborating with experienced professionals with a proven track record. We help you navigate the complexities of peptide and protein drug product development and make sure that your injectable drug product is robust and suited for the relevant clinical stage.
All aspects of formulation and process development can be supported from first human dose to commercial launch including technology transfer and CDMO management.
We also offer contract laboratory services through our sister company Formula One which is a fully integrated formulation development organization specializing in peptide and protein therapeutics.
Examples on development activities supported:
Drug product development strategy from early to late phase development. Experience in both new biological entities and biosimilars.
Drug product development planning. Defining key CMC project tasks and best timing of activities in line with project milestones.
Formulation screening for lead selection for first human trial.
Formulation robustness assessment prior to commercial submission.
Design of drug product stability studies to support shelf life and in-use claims including statistical data analysis.
Process design and control strategy for drug product manufacturing relating to injectable proteins and peptides.
Tech transfer of drug product process from lab scale to GMP facility for clinical trial batch production.
Biosimilar formulation strategy and comparability evaluation
Design of comparability protocols to support process and product changes
Coordination of experiments at CDMOs including collection, review and reporting of data to facilitate decision-making.
Once your drug product is ready for clinical testing or commercial launch we can help with the regulatory CMC writing of the dossier. For more information on our regulatory services click here.