Legal Experience
Mark Byrne is a scientist with more than twenty-five years of experience in the biotechnology industry. Mark’s technical background includes experience in research and development, as a protein and DNA chemist, and as a quality control manager at several commercial biotechnology companies and a major university. He received a Bachelor of Science degree in Chemistry from Alma College in 1971, and a Masters in Public Health from the University of Michigan in 1984. He has attended numerous seminars and workshops covering Regulatory Affairs and FDA Compliance, Microencapsulation Techniques; Radiation Health Safety, and Neutron Activation Analysis. Mark’s patent practice includes reviewing, evaluating, and designing around patents in the biotechnology industry.

As registered patent agent, Mr. Byrne focuses his practice on the preparation and prosecution of patent applications in the chemical and biological arts, drawing from more than 25 years of laboratory-based experience in bio-diagnostics and bio-therapeutics. Mr. Byrne has worked for several biotechnology, pharmaceutical, and medical device companies, and has conducted significant university research. His extensive experience includes:

The development of current good manufacturing procedures (cGMP) based on reagent purification protocols.

Leading the development of several commercially successful FDA licensed enzyme immunoassay (EIAs) diagnostics to viral, bacterial, and cancer antigens.

Manufacturing, under FDA cGMP criteria, injectable monoclonal antibodies from cell culture stocks to the required multi-gram quantities for clinical trials.

Implementing analytical procedures using high-pressure liquid chromatography (HPLC), isoelectric focusing, polyacrylamide gel electrophoresis (PAGE), and pyrogen testing methods.

The use of viral cell culture and bacterial production techniques; the expansion, extraction, and purification of recombinant derived antigens; and radioisotope molecular labeling.

Establishing a DNA synthesis and purification laboratory for biotin or enzyme probe assay development.

Operation of a QC laboratory and management of QC analytical development for an FDA licensed therapeutic device for the treatment of rheumatoid arthritis (RA) and idiopathic thrombocytopenic purpura (ITP) immune-disorder diseases.

Publications

Landefeld TD, Byrne MD, Campbell KC, Midgley Jr. AR, 1981. Differential processing of the two subunits of human choriogonadotrpin (hCG) by granulosa cells. I. Preparation and characterization of selectively labeled HCG, Endocrinology 109:1851.

Campbell KC, Bagavandoss P, Byrne MD, et al, 1981. Differential processing of the two subunits of human choriogonadotropin (hCG) by granulosa cells. II. In-Vivo Studies, Endocrinology 109:1858.

Teaching

1979 – 1982. Part-time Chemistry Instructor, Washtenaw Community College, Ann Arbor, MI. Taught general laboratory chemistry courses.