In the development of biological formulations, the main goal is to find solutions that provide stable solution conditions to support the higher-order structure of the molecule, thus being able to provide a high proportion of biologically active native proteins. Denatured proteins tend to be more susceptible to irreversible chemical processes such as proteolysis, oxidation, and deamidation, which in turn lead to inactivation and the risk of aggregation, which may cause adverse immunogenicity effects

During formulation development, biomolecules are exposed to a variety of conditions, including:

• Different buffers, temperatures, shear forces, pH, and salt concentrations

• A variety of excipients used to help stabilize proteins or to aid in manufacturing or drug delivery

• High concentration, which is used to determine how concentrated a candidate drug is in a series of buffers and additives before protein aggregation occurs

To ensure that your chosen route of administration has a long product shelf life and appropriate formulation, creating a stable environment is essential for your biological products. To help you, we specialise in formulation development according to your exact needs

We can help you:

•formulation design

•Study on compatibility of raw materials

•Selection and optimization of formulations

•Preparation process design

•scale-up