Posts by Dominic Warrino, Ph.D.
Dominic's role is to lead a team of scientific advisors for both clients and internal teams for development, validation, and sample analysis for support of PK, immunogenicity, and biomarker methods for a wide range of therapeutics. Dominic has 30 years of experience developing and validating assays for support of drug development.
Posters & Papers
This article provides updated recommendations for the bioanalysis of antibody-drug conjugates (ADCs), reflecting more than a decade of advances in the field. Developed by the AAPS ADC Working Group, it addresses key considerations for quantifying total antibody, conjugated ADC, free payload, and drug-to-antibody ratio (DAR), as well as immunogenicity,…
Posters & Papers
This article provides harmonized recommendations for the validation and reporting of neutralizing antibody (NAb) assays, addressing challenges associated with both cell-based and non-cell-based formats. Developed by experts from industry and the FDA through the American Association of Pharmaceutical Scientists’ Therapeutic Product Immunogenicity Community, the recommendations cover key assay performance…
Posters & Papers
Bispecific protein therapeutics present unique challenges for pharmacokinetic (PK) characterization because multiple functional domains must be evaluated, along with potential biotransformation and interference from anti-therapeutic antibodies. This review presents case studies and a regulatory perspective on developing PK assay strategies for bispecific molecules, emphasizing the need to consider each…
Blogs
When you examine how to develop and validate/qualify a Biodistribution assay by PCR…
Blogs
Cell and Gene Therapies (CGTs) are types of treatment that uses cellular or genetic material with the goal of treating a disease or a disordered. Often it can be a combination of cell and gene therapies, which is the case for Chimeric antigen receptor T cells (CAR T-Cells). There are…
Videos
Dawn Dufield, Ph.D. and Dominic Warrino, Ph.D. discuss their approach to ligand binding assays (LBAs) and hybrid mass spectrometry (Hybrid LC-MS/MS) in this 11-part video series. What Makes a Good CRO for Bioanalysis? Are there any specific technologies that are more useful to have together? What is a…
Blogs
In the complex and dynamic bioanalytical landscape of antibody-drug conjugate (ADC) services, where often time is critical and every research dollar counts, hybrid technology is quickly emerging as a game-changer. Hybrid offers a spectrum of advantages that redefine traditional approaches to bioanalytical ADC drug development. At the forefront…
Blogs
If you are part of the Biotech/Pharma community, you may be familiar with the (J.P. Morgan) JPM Healthcare Conference that takes place annually in January and typically in San Francisco. This was the 42nd Annual JPM Healthcare Conference and it is the world’s largest healthcare symposium. This year the…
webinars
Produced by Bioanalysis Zone Recorded on December 11, 2023 Webinar available here. Webinar Description: In this webinar, Dominic Warrino discusses the bioanalytical considerations of immunogenicity of cell and gene therapies. Bioanalysis method development and method validation of immunogenicity assays for support of cell and…
Blogs
In the ever-evolving landscape of pharmaceutical research, biodistribution studies play a pivotal role in understanding how drugs and therapies are distributed within the body. These studies are critical for assessing the efficacy and safety of new treatments, particularly in the realm of cell…
Blogs
In 2022 we had 42 FDA Drug Approvals and 3 were Gene Therapies using a viral vector. 2 of the approvals in 2022 were AAV based. The third is manufactured by adding functional copies of the transgene to the patient’s own Hematopoietic Stem Cells (HSCs)…
Blogs
Cell and Gene Therapies (CGTs) has an estimated market size value in 2022 of USD 8.22 billion and a revenue forecast in 2030 of USD 24.5 billion. This is a CAGR (compound annual growth rate) of 14.6% from 2022 to 2030. Needless to say, the…