Cutting-Edge PK and Immunogenicity Strategies for Next-Generation ADCs, ARCs, and Conjugated Biotherapeutics

In this webinar, the expert speakers will explore advanced conjugation technologies such as antibody-drug conjugates (ADCs), antibody-RNA-conjugates (ARCs), siRNA/oligos and antibody-peptide conjugates, as well as discuss the best bioanalytical support strategies for these therapies.

Bioanalysis for support of next-generation ADCs and ARCs have exploded recently due to the efficacy and safety that these therapies offer for immuno-oncology, rare diseases, vaccines and potentially many other diseases.

ADCs tend to consist of a toxic small molecule payload attached via a linker to an antibody. The application of these drugs had mainly been in oncology where their mode of action is for the antibody to attach at the desired target site with subsequent release of the small molecule to combat tumor cells. Recently, we have seen a much wider application or use of “ADCs” to other modalities such as antibody-peptide conjugates, ARCs or even other more complicated multi-functional entities.

Having a therapeutic entity with multiple distinct components means that we need to have analytical methodologies for various components. Traditionally, LC-MS/MS has mainly been applied to the quantitation of the small molecule payload or the linker moiety. Ligand-binding assays had been successful for quantitation of the intact ADC or the antibody portion.

The expert speakers will discuss the latest and greatest conjugation technologies (ADCs, ARCs/siRNA/Oligo’s, Antibody peptide conjugates) and how best to support them bioanalytically. Those attending will specifically have the benefit of learning which PK methods are required for bioanalysis of conjugated drugs, various platforms used for PK methods, strategies for selection of the platform to be used for PK methods and PK case studies of conjugated drugs.

Additionally, this webinar will discuss immunogenicity strategies and case studies for support of conjugated drugs. Attendees will also learn what critical reagents are needed/recommended for support of conjugated drugs, challenges with multiplexing PK assays and regulatory expectations. Register for this webinar to learn how best to address these challenges.

Speakers

Dominic Warrino, PhD, Senior Director of Scientific Services, KCAS Bio

Dominic Warrino, PhD, is a Senior Director of Scientific Services. His role is to lead a team of Sr. 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 (biopharmaceutical, 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 (formally IBT; MO, USA), and previously also worked for Cytogen (formally Cellcor; NJ, USA), Eligix (MA, USA) and Streck Laboratories (NE, USA) developing novel compounds for the treatment of various cancers.

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Dawn Dufield, PhD, 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 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 LCMS.

Dawn is a co-author on a white paper on recommendations for the validation of LCMS-based bioanalytical methods for protein biotherapeutics. She has been working on the bioanalysis of ADCs 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.

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