Biologics and biosimilars characterization

Biopharmaceuticals are becoming a significant treatment options for a wide array of diseases. However, their complexity and large size complicates their production. In addition, with the expiration of patents for several biologics, interest in the development of similar products (biosimilars) have risen and generated new challenges for approval; the most important being to prove the full similarity to the original biologic. Manufacturing of biotherapeutics is a complex process that presents similar challenges as protein crystallization, both in terms of formulation and stability. We can therefore apply similar analytical procedures to help manufacturers of biotherapeutics achieve the highest stability of their final product.

Biologics

Bringing your biologic to high concentration for end product formulation can be quite a challenge. We have the tools to fully characterize the aggregation state of your product and optimize the final solution for the highest stability. Several excipients can be rapidly screened to evaluate their effect on the stability of the target.
Epitope mapping can be an important asset in patent enforcement and litigation or sometimes just to understand, at the atomic level, the type of interactions your biologic makes with the target. IniXium provides structures of antibody or Fab + antigen complexes to fully characterize your epitope.

Biosimilars

A full analytical characterization of your biosimilar can be done to confirm true similarity to the parent biologic. This characterization includes overall purity, thermal stability, aggregation state, binding activity, etc.
Three-dimensional structure by x-ray crystallography will confirm the structural similarity of your material, including the organization of the post-translational modifications. The three-dimensional structure will also validate the epitope of your biosimilar.