The innovation described in this proposal is aimed to providing a new method for characterization of lot-to-lot consistency of microheterogeneous recombinant products. The biological effect and potency of a drug is governed by the chemical structure for both traditional drugs and pharmaceuticals. Standard analytical techniques are either inadequate for complete characterization of protein-based products or too costly and complex. This SBIR proposal is targeted at difficult quality control and characterization problems associated with microheterogeneity of widely available recombinant glycoproteins. ANALIZA is proposing to develop an validate a physico-chemical test useful for both in-process and final lot release analyses. The proposed methodology is unique (in regard to the type of information obtained), quantitative, in expensive (relative to present methodologies), flexible (in that is may be used for different biopharmaceuticals), easy to perform and labor-efficient. the technique provides a unique and highly sensitive information on minor changes in the structure and conformation of the glycoprotein product. Phase II research effort is designed to demonstrate the generality of the proposed innovation, to study issues related to method validation, to examine its potential for up-stream quality control applications and to develop a preliminary automated instrumentation.
The principal commercial applications of this innovation are in the area of quality control and assurance of recombinant DNA therapeutical agents that are manufactured in the biotechnology industry. Additional applications are envisioned in characterization of heterogeneous mixtures of closely related biomolecules that may be of importance to both the medical and veterinary diagnostics fields.
