Posts by Dominic Warrino, Ph.D.

Dominic's role is to serve as scientific and technical advisor for both clients and internal teams for development, validation, and application of bioanalytical, immunogenicity, and biomarker methods for large molecule therapeutics. He has 20 years of experience developing and validating immunological assays for biotechnology and pharmaceutical companies.

KCAS-blog-thumb_2024-ADCsHybridTech Blogs
Read article Harnessing the Potential of Hybrid Technology in Antibody Drug Conjugate Services

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 of these…

KCAS-blog-thumb_2024-01B_JPM-ADCs Blogs
Read article ADCs at the Forefront of J.P. Morgan Annual Conference in 2024

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 mood…

PATTERN_BLUE_1320x780_2 Webinars
View webinar KCAS Bio Webinar – Produced by Bioanalysis Zone “Bioanalytical Considerations for Immunogenicity of Cell and Gene Therapies”

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…

PATTERN_BLUE_1320x780 Blogs
Read article The Evolution of Biodistribution Studies: Deciding Between Qualified vs. Validated Methods

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…

KCAS-blog-thumb_2023_01-B_Viral-Vectors-1 Blogs
Read article The Role Bioanalysis is Playing in Support of Viral Vector Drug Development

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)…

KCAS-blog-thumb_2022_GLP-CGT Blogs
Read article Is GLP Bioanalysis needed to support your Cell and Gene Therapy GLP Tox Studies?

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…

KCAS-blog-thumb_2022_Webinar-CGT-June-2022-1 Webinars
View webinar Upcoming KCAS Webinar (June 24th): “The Age of Cell and Gene Therapies is Upon Us – So What Does That Mean for Bioanalysis?”

Being produced by Xtalks on Friday, June 24, 2022 | 12pm EDT (NA) / 5pm BST (UK) / 6pm CEST (EU-Central) 60 min Webinar Description: Cell and gene therapies (CGTs) are types of treatment that use cellular or genetic material with the goal of treating a disease or a…

PATTERN_AMBER_1320x780_2 Blogs
Read article The Age of Cell & Gene Therapies is Upon Us. So What Does That Mean?

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).  As of…

PATTERN_ORANGE_1320x780_3 Blogs
Read article Clinical Support and Kitting (CSK) Drug Development Solutions for Support of Cell & Gene Therapies

The age of cell and gene therapies (CGTs) is upon us! It has been a long road to get to this time. The first gene therapy trial on humans was performed in 1990 by researchers at the National Institutes of Health. The first FDA approved CGT came in 2017. One…

KCAS-blog-thumb_2022_Tissues-Lrg-Mol Blogs
Read article Measuring Biomarkers (PD) and drug levels (PK) in Tissues and Non-Liquid Matrices

Tissue and Non-Liquid Matrices (such as cell lines, red blood cells, PBMCs, bone marrow aspirates, and suspension cells) are valuable matrices[] to test for biomarkers (PD) and drug levels (PK). Testing of tissues and…

KCAS-blog-thumb_2022_LBA-and-LCMSMS Blogs
Read article Combining the Benefits of LBA and LC-MS/MS for Pharmacodynamics at KCAS

Pharmacodynamics (PD) is defined as the study of the biochemical and physiological effects of drugs and the mechanisms of their actions. Where pharmacokinetics looks at how the organism processes the drug, pharmacodynamics studies how…