CEO, Bio-Val Consulting
"Solving today's analytical problems
while preventing tomorrow's."
- Kristin Clement, CEO Bio-Val Consulting, LLC
Kristin Clement, Ph.D.
Assay Development and Validation Subject Matter Expert
I am CEO of Bio-Val Consulting, LLC (BVC), a woman-owned small business committed to helping clients meet today's demands for regulatory compliance with their bioanalytical needs. My mission is to assist clients to condense drug development timelines and get products to market efficiently without compromising quality or budget. I have consulted on projects that include the development and validation of antibody detection assays in support of SARS-CoV2 (etiologic agent for Covid-19) for Operation Warp Speed (OWS), potency assays in support of cell and gene therapy and mAb GMP release, clinical testing assays for antibodies against anthrax and RSV vaccines in development, among others.
I offer 24 combined years of academic, GLP contract research, and GMP consulting experience developing quantitative MOA-based bioassays to support all stages of drug research and development, including antibody screening, characterization, potency and stability testing.
"My passion is helping companies overcome analytical hurdles by meeting them where they're at and elevating them to where they need to be."
Research Interests
Cell and Gene Therapy: cGMP release assays (platform and product specific cell-based potency assays) for both Lentiviral and AAV gene therapy viral vectors. Also, for-information-only and cGMP release assays for autologous CD34+stem cell products for the treatment of hematologic disorders.
Assay Types: ELISA (direct, sandwich, competitive, kinetic), ECL (Meso Scale Discovery), Cell based assays (e.g. Neutralization, Binding, Phagocytosis, ELISpot, etc.), Antibody purification, cAMP stimulation assays (HTRF, Promega GloMax®), Protein expression (flow cytometry, SDS-PAGE/Western Blot, PCR, Lateral Flow), and gene expression (ddPCR and qPCR).
Experience Developing Assays for these target diseases or compounds:
• Infectious diseases: SARS-Cov-2 (Covid-19 via Operation Warp Speed), Bordetella Pertussis (Whooping Cough), Ebola/Marburg, Anthrax, Plague, Tularemia, Brucella, RSV, Histoplasmosis,
• Nerve agent/Organophosphate poisoning: Sarin, Soman, Tabun, VX, and various pesticides such as malathion, diazinon, dichlorvos, fenthion, and chlorpyrifos (developing lateral flow diagnostic point of care tests)
• Genetic disorders: Sickle Cell Disease and Beta-Thalassemia
• Other chronic diseases: Breast Cancer, Migraine
Publications
Clement, KH and Basinger WG, “Detection of the Degree of Exposure to Chemical Warfare Nerve Agents and Organophosphate Pestidicides with Lateral Flow Assays.” U.S. Patent Application No. 10,288,614.
Ionin, B, R Hopkins, B Pleune, G Sivko, F Reid, KH Clement, T Rudge, G Stark, A Innes, S Sari, T Guina, C Howard, J Smith, ML Swoboda, E Vert-Wong, V Johnson, G Nabors, and M Skiadopoulos. 2013. Evaluation of Immunogenicity and Efficacy of Biothrax® (Anthrax Vaccine Adsorbed) for Post-Exposure Prophylaxis. Microb Immun Vaccines. Manuscript in Press; Accepted with Revisions.
Clement KH, TL Rudge Jr, HJ Mayfield, LA Carlton, A Hester, NA Niemuth, CL Sabourin, AM Brys, and CP Quinn. 2010. Vaccination of rhesus macaques with the anthrax vaccine adsorbed vaccine produces a serum antibody response that effectively neutralizes receptor-bound protective antigen in vitro. Clin Vacc Immun. 17(11):1753-62