The capabilities of KCAS Bio: PK, biomarkers and immunogenicity testing all under one roof
In this interview, Dominic Warrino, Ph.D. and Dawn Dufield, Ph.D. (both KCAS Bio; KS, USA) discuss the drug modalities and disease indications KCAS Bio can support. The pair shares their recommendations on pharmacokinetic (PK), biomarker and immunogenicity platforms, and how they are able to harness KCAS Bio’s LBA and LC–MS capabilities to solve any problem thrown their way. Dom and Dawn also reflect on how KCAS Bio has expanded and invested throughout its 45-year history.
Questions:
- KCAS Bio supports PK, biomarkers and immunogenicity testing for all drug modalities. What are the benefits of having this all under one roof?
- What platforms would you recommend to your sponsors for PK analysis?
- What drug modalities does KCAS Bio support?
- What are the disease indications that KCAS Bio supports?
- KCAS Bio started as a small molecule CRO over 45 years ago, but how would you describe KCAS Bio now?
Dawn R. Dufield, Ph.D.
Scientific Officer, Mass Spectrometry
KCAS Bio
Dawn R. Dufield is the Scientific Officer for Mass Spectrometry at KCAS Bio. She has been at KCAS since 2018 and was previously with Pfizer (NY, USA) for over 20 years, working in the quantitative large and small molecule LC–MS/MS field. She was one of the early pioneers of using immunoaffinity combined with LC–MS/MS to offer additional selectivity, which is now commonly referred to as hybrid LC–MS.
Dawn is a co-author on a White Paper on recommendations for the validation of LC–MS-based bioanalytical methods for protein biotherapeutics. She has been working on the bioanalysis of antibody-drug conjugates for over 15 years and has contributed to a book chapter on this topic. She has numerous publications in her field and is an active member of AAPS and ASMS.
Dominic Warrino, Ph.D.
Senior Director of Scientific Services
KCAS Bio
Dominic Warrino is a Senior Director of Scientific Services. His role is to lead a team of Senior Scientific Advisors and Scientific Advisors who are liaisons for both clients and internal teams regarding development, validation and application of bioanalytical PK, immunogenicity, PD and biomarker methods for all therapeutic modalities (biopharmaceuticals, pharmaceuticals, gene therapies and cell-based gene therapies).
Dominic joined the company in 2013 and brought with him expertise in a full range of bioanalytical techniques, including ECL, ELISA, RIA, flow cytometry, ELISpot, cell-based assays and Luminex. He has 30 years of experience developing and validating immunological assays for biotechnology and pharmaceutical companies.
Prior to working at KCAS Bio, he spent several years in the Biopharma Services department at Viracor-IBT (formerly IBT; MO, USA), and previously also worked for Cytogen (formerly Cellcor; NJ, USA), Eligix (MA, USA) and Streck Laboratories (NE, USA), developing novel compounds for the treatment of various cancers.
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