The bioanalytical landscape for support of biopharmaceuticals (biologics or large molecules) and biomarker testing is an ever changing map. The industry is currently focused on low level sensitivity, data integrity, and compliance with the new FDA guidelines that regulated bioanalysis must keep up with.

While attending the 2018 Workshop on Recent Issues in Bioanalysis I had the good fortune to participate in a panel discussion on new platforms for biopharmaceuticals. The focus was on the need for greater sensitivity and data integrity using new instrumentation. Additionally, while at WRIB the FDA noted that the 5 most common deficiency categories were: validation, record keeping, reserve samples, stability, and quality control samples.

The Ligand Binding Assay (LBA) team at KCAS is growing to meet these changes for bioanalytical support of biopharmaceuticals and biomarker testing. The specific areas we are seeing the biggest need for growth is in the areas of Immuno-Oncology therapies, cell/gene therapies, monoclonal antibodies and Antibody Drug Conjugates (ADCs). To keep up with this growth, in 2018 KCAS has implemented several changes.

Two recent platforms have been added, MilliporeSigma SMCxPROâ„¢ and Luminex 200, which complements our imaging cytometry, flow cytometry, cell based assays, ELISA by absorbance/fluorescence/luminescence/HTRF, and Meso Scale Discovery S600.

The footprint of the LBA laboratory doubled in space to accommodate up to 25 scientists, additional instrumentation, and equipment. Included in the remodel our cell culture suite expanded. This has allowed us to bring on ELISPOT services as well.

Watson LIMS was installed in the spring of 2018.

Lastly, all these fancy instruments and a beautiful expanded laboratory space would be useless without people. As a company we recruit like a division one football team and we have had no problems finding the right people to add to the team. Frank Spriggs, director LBA, joined in summer of 2017. Under his leadership the team has increased from 6 FTEs to 18 FTEs. Productivity has increased 5-fold. We are ready to help you develop drugs.

New lab, new equipment, and an energized team are all great to have, but when performing regulatory work it takes more than these items. KCAS has a 40 year history and been audited 16 times by the FDA. We understand how to qualify new technologies and perform regulated work. One of the challenges with flow cytometry, imaging cytometry, and ELISPOTs is the lack of regulatory white papers or guidelines. It is like the wild wild west when one examines the regulatory landscape for these platforms with respect to GLP compliance. One of our goals is to work with regulatory agencies, other CROs, and industry to provide a white paper or guidance to help bring these platforms to GLP compliance.

If you are not familiar with the KCAS LBA team I encourage you to get to know us. Like many of our clients we can help you sleep better at night knowing your LBA bioanalytical needs are on time and within budget.