In the early stages of research and pre-clinical development, little is often known about the product with respect to its key features, for example its functional characteristics, its glycan structures or post translational modifications (for recombinant proteins) or basic stability features in research buffers and formulations.
To start the gathering of this important product information and to support its process development activities, Batavia Bioservices offers a number of product characterization services for all the major classes of biopharmaceuticals (vaccines, viral vectors and recombinant proteins).
The analyses offered include the following:
Glycan profiling by normal phase and anion exchange HPLC can be used to determine the antennarity (branching) and charge of sugar structures present on a protein by separating the glycan pool into a number of fractions based either on charge or size. This results in the A (antennarity) number and the Z (charge) number for that protein, which can be used to compare the recombinant protein variants with for example the endogenous human protein and used as a selective tool. Furthermore it provides an estimation of the % sialylation, which may be indicative of in-vivo half life.
Once separated by HPLC, the exact structures of the glycans in each pool can then be identified by Mass Spectrometry. The mass spectrometry is performed by a partner but the identification, using a database of glycan structures, is performed in-house.
Batavia Bioservices has expertise and experience in developing and implementing a number of different functional assays. These include TCID50 (Tissue Culture Infectious Dose 50) and SRID (Single Radial Immunodiffusion Assay) based assays for vaccines and viral vectors as well as cell based assays such as CDC (Complement Dependent Cytotoxicity) and ADCC (Antibody-Dependent Cell mediated Cytotoxicity) assays. Moreover, our staff have considerable experience in product specific cell based and functional assays such as in the field of blood coagulation, transporter and uptake assays and virus neutralization assays.
In parallel with research and early product development programs, it is often necessary to determine basic stability profiles of new products, for example stability in certain buffers and formulations and at certain temperatures to determine the operating range that is permitted for working with such a product. Of course, investigation into product stability is limited to the stability indicating assays that are available at these early stages of development. Batavia Bioservices can develop such assays (see Process Development - Assay Development) and apply them to monitor product stability and establish basic parameters for product storage.