Formulation development is critical to the therapeutic and commercial success of a promising biopharmaceutical compound

From the early stages of research and development, a robust formulation is crucial to pave the way to successful commercialization, as biopharmaceutical molecules are often inherently unstable and need to be stabilized. Our formulation development services deliver biopharmaceutical drug products that are robust for manufacture, storage, handling and delivery to patients. We offer formulation development for a wide range of structurally diverse (bio)pharmaceuticals, including proteins, vaccines, gene therapy products, viral vectors, nucleic acids, antibodies or related products, peptides, cell therapy products, drug delivery systems and small molecules.

Liquid, frozen and lyophilized formulations tailored to your needs

We develop liquid, frozen and lyophilized drug formulations to fit the needs of your molecule and development phase. In a unique collaborative approach, our experts focus on your Target Product Profile (TPP) and customize the study design to meet your needs. When executing a project, we consider the availability of active ingredients, relevant deadlines and your overall development strategy. Already during the first project talks with us, you benefit from the advice of our renowned scientific advisory board. In addition, our large service portfolio gives you the flexibility to easily switch from a liquid to a lyophilized formulation or to explore different formulation types in parallel.

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

• Pre-formulation screening: including identification of appropriate formulation corridors and compositions (pH, ionic strength, protein concentration, excipients, etc.); identifying degradation products; Choosing stability indication methods; High-throughput formulation approaches based on the experimental design are possible to reduce the required material and time

• Preclinical formulation development: Liquid, frozen or freeze-dried formulations (eg for toxicological studies) are developed and can be manufactured under aseptic conditions

• Transfer of recipes to the external CMO of your choice, including on-site process transfer if required. This lowers your costs and maintains your flexibility

• Formulation development for clinical phases I and II

• Formulations for late clinical development (phase III) and commercial use