The number of marketed FDA-approved biologic-based medical products, or biopharmaceuticals, is increasing at a rapid rate. Biopharmaceutical products include live vaccines, monoclonal antibodies, recombinant proteins and enzymes. Biotechnology products are also found in consumer diagnostic products such as home pregnancy or home ovulation tests. The commercial success of these products has led to increased efforts to produce and market biopharmaceuticals, which has resulted in an increase in the frequency of litigation involving patent infringement.
For infringement matters involving biopharmaceutical products, you can rely on PharmaForensics Laboratories. We provide accurate, reliable technical expertise and comprehensive experimental solutions to answer critical questions about the properties of a biopharmaceutical product. For example:
- How tightly does an antibody bind its antigen in vitro?
- How effective is an antibody in binding its antigen in a cell-based assay?
- How much antigen is present in a sample?
- How is a recombinant protein produced and purified?
- What is the catalytic activity of a recombinant enzyme?
- What is the amino acid sequence of a protein, antibody or enzyme?
- What is the mass of a recombinant antibody or protein?
- What is the stability of recombinant protein or antibody?
To answer these and many other important questions regarding biopharmaceutical products, we use state-of-the-art experimental techniques and equipment, including HPLC-Mass Spectrometry, Biacore, FPLC protein purification and others. We also use a variety of spectrophotometric equipment and plate readers (UV-Vis, fluorescence, etc.) to monitor enzyme catalysis and antibody-antigen binding. We have the ability to run PAGE gel analysis, and can extend this to Western Blot analysis. Finally, access to the cell culture suite at the University of Michigan enables us to maintain cell cultures to support any required cell based assay.
Contact us today to find out more about our biochemical analytical services and learn how we can help you with your matter.