From the early stages of research and development, a robust formulation is crucial for paving the road to a successful commercialization because biopharmaceutical molecules are often inherently unstable and require stabilization. Our formulation development services deliver biopharmaceutical drug products that are robust for manufacturing, storage, handling, and administration to patients. We offer formulation development for wide range of structurally diverse (bio)pharmaceuticals, including proteins, vaccines, gene therapy products, viral vectors, nucleic acids, antibodies or related products, peptide, cell therapy products, drug delivery system and small molecules. 

Liquid, frozen and lyophilized formulations tailored to your needs

We develop formulations for liquid, frozen and lyophilized drug products that fit the needs of your molecule and development phase. In a unique collaborative approach, our experts concentrate on your target product profile (TPP) and tailor the study design to your requirements. We consider drug substance availability, relevant deadlines and your overall development strategy when conducting a project. Already during initial project discussions with us, you will benefit from the advice of our distinguished scientific advisory board. Also, our large service portfolio gives you the flexibility to readily switch from a liquid to a lyophilized formulation or explore different formulation types in parallel.

With many years of experience in the field of formulation development, we offer:

• preformulation screening: including identifying suitable formulation corridor and 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
• preclinical formulation development: liquid, frozen or freeze-dried formulations (e.g., for toxicological studies) are developed and can be produced under aseptic conditions
• transfer of formulations to the external CMO of your choice including process transfer on site if desired. This reduces your costs and maintains your flexibility
• formulation development for clinical phase I and II
• formulations for late clinical development (phase III) and commercial application