Formulation development is essential for the therapeutic and commercial success of a promising therapeutic molecule.
It aims to render a biopharmaceutical drug product robust for manufacturing, storage, handling and administration to patients. All biopharmaceutical molecules, being it proteins (such as monoclonal antibodies or hormones), peptides, vaccines, virus-like particles, DNA- or RNA- based products, need to be formulated, even in early stages of research. This is because biopharmaceutical molecules are often inherently unstable. A variety of different formulation types are possible to stabilize a biopharmaceutical molecule. Most common are liquid and lyophilized formulations. However, also frozen liquids or high-concentration liquid formulation (HCLF) can be required.
A good formulation development can only be conducted when its foundation is a broad analytical portfolio, because if the employed analytics cannot detect critical degradation pathways, all formulations will appear stable. Thus, Coriolis Pharma will recommend a tailored analytical package to gain the maximum information on the stability of the molecule of interest from the generated sample.
With many years of experience in the field of formulation development, we can offer:
- pre-formulation screening: including identifying suitable formulation composition (pH, ionic strength, protein concentration, excipients, etc.); identifying degradation products; selecting stability-indicating methods; high throughput formulation approaches based on design of experiment are possible to reduce the required material and time
- pre-clinical formulation development: liquid, frozen or dried formulations (e.g., for tox-studies) are developed and can be produced under sterile conditions
- transfer of formulations to the external CMO of our customers choice (thereby being much more price competitive and flexible) including process transfer on site if desired
- formulation development for clinical phase I and II
- formulations for late clinical development (phase III) and commercial application