Dr. Lipscomb provides consulting services and technical expertise in the areas of Analytical Methods Development and Validation, Process Development and Validation, cGMP Facility Commissioning and Inspection, Quality Assurance Audits and On-Site Gap Analysis for Quality Programs. He has participated in audits of validation reports for license applications, participated in regulatory submissions (e.g., IND, BLA, and DMF) and provided support for company information management and web systems. He has been working in regulated biotechnology research since 1998 as a graduate student at the University of Colorado, Boulder. In the summer of 2001, Dr. Lipscomb joined CBR International as a Regulatory Intern.

Dr. Lipscomb graduated with a B.S. in Chemical Engineering from Clemson University in May 1998, with emphasis in Bioengineering and Biomedical Engineering. During his undergraduate career, he carried out research in the area of mass transfer of large molecules in food grade packaging films. During the summer of 1997, he was an NSF Fellow at the University of Colorado, Boulder participating in the Research Experience for Undergraduates Program (NSF-REU) in the Department of Chemical Engineering where he developed novel, biodegradable photopolymers for drug delivery applications.

In August of 2000, Dr. Lipscomb graduated with a M.S. in Chemical Engineering from the University of Colorado, Boulder. His thesis investigated a novel technique to create and evaluate in vitro tissue equivalents with the specific application to studying myocardial infarction. His approach combined fundamental molecular biology with state of the art mechanical testing to develop a complete picture of dynamic heart tissue.

Dr. Lipscomb is completed his Ph.D. in Chemical Engineering at the University of Colorado in May 2005 in the field of recombinant mammalian cell technology. His research utilized a dual plasmid, inducible expression system in Chinese hamster ovary (CHO) cells with bench scale production and purification of a recombinant reporter protein in controlled bioreactor systems. The major thrusts of his work included: 1) Demonstration that the combination of an inducible expression system with culture in a perfusion bioreactor resulted in a synergistic increase in the specific productivity of the cell line as compared to batch cultures, 2) Determination of the independent effects of gene amplification and culture method on the glycosylation of the recombinant protein, and 3) The development of a mathematical model to describe the observed decay of specific productivity apparent during long term culture of the recombinant cell line. While at CU, Dr. Lipscomb was involved in the Biotechnology Leadership Program, a joint program with the departments of Chemical Engineering, Molecular and Cellular Biology, and Biochemistry.

As a Technical Consultant for CBR International, Dr. Lipscomb specializes in Facility and Gap Analysis for Quality Programs, the development and preparation of technical documents including CMC Documents for IND and BLA submissions, Technical Reports, Program Development Plans, Standard Operating Procedures (SOPs), and Post-Audit Action Plans to support Quality Assurance programs. Dr. Lipscomb has expanded the company’s expertise with his knowledge in the disciplines of chemical engineering and biotechnology. With this addition, and other CBR International affiliations, CBR International can offer the services of high quality professionals that work as a team to address specific client program issues in a highly cost effective manner.

Consistent, thorough and up-to-date analysis of your evolving needs is just the beginning of our commitment to your program. For a comprehensive assessment of your program requirements, please contact us by calling (720) 746-1190 or by email at info@cbrintl.com.