Being that it is a relatively “niche” segment of the industry, there are several key areas that need to be considered in the field of molecular services related to cell and gene therapies. First and foremost, it is important to recognize that regulatory guidelines within this field are…

Anyone who has been following KCAS for any amount of time has likely heard us discuss the advantages of Hybrid LC-MS/MS for the bioanalysis of large molecules. As pioneers in the technology for many years, KCAS has become a strong proponent of working with our customers to demonstrate the quality…

Understanding the interactions between drugs and biological systems is critical for the success of a new drug. One key tool in this process is functional assays. Functional assays are customized assays that evaluate the impact of drugs on the functionality of cells. They test for a drug’s specific biological mechanism…

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)…

Due to its ability to analyze multiple parameters across different cell types within a sample, flow cytometry provides rich and clinically valuable data sets from even small volumes of blood. However, flow cytometry is a challenging platform to master, and requires significant investment in equipment and technical training.

With the extensive advances in technologies like CRISPR and CAR-T, cell and gene therapy has grown to become a viable way for treating Cancer as well as other diseases. Our team has over 100+ years of collective expertise in molecular services using qPCR and ddPCR for support of…

Dr. Sohrab Habibi Goudarzi – Senior Director of Pharma Discovery and R&D Services, Bryan Parmentier – Senior Principal Scientist of Pharma Method Development, and Yu-Hui (Ann) Fu -Principal Scientist of Pharma Regulatory, along with other scientists at KCAS Bioanalytical & Biomarker Services, coauthored with scientists at Gilead Sciences, Inc. in…

Due to the relative maturity of the technology, most people’s instinct when thinking about bioanalysis of large molecules is towards ligand binding assays. However, we urge people to be open to a more flexible approach. Using hybrid LC-MS/MS can be an equally useful tool for quantitation of biological therapeutics and…

Assay validation is required during the development of new drugs or biologics in order to be in compliance with regulatory requirements for all studies that are not considered research/exploratory in nature. Beyond compliance, what is the point of assay validation? Assays must be precise, robust, and specific during use in preclinical studies and clinical trials in order to assure that drug candidates can be accurately evaluated for safety and efficacy. Validation plans assure that an assay will work reliably, even if an assay is run at different sites or by different users. Consider these other elements of assay validation to understand why it is a critical to preclinical and clinical research:   Fit-for-purpose strategy: Each validation plan determines if an assay is made to be fit-for-purpose for a given client’s evaluation needs. Assays can be customized to meet the specific needs of a preclinical screening or clinical trial and fit-for-purpose validation assures that reliable data can be obtained from assay. Test scripts: Test scripts are a series of procedures to be executed during a validation in order to determine if an assay satisfies the necessary specifications or to reveal errors that must be addressed. Running test scripts is essential to the development and continued reliability of a validated assay. GLP compliance: Assay validation must be carried out under the same conditions as will be used for routine assay use. Good laboratory practices (GLP) conditions are needed for many preclinical and clinical applications, and routine quality assurance/quality control monitoring may also be necessary. Be aware of these special circumstances during assay validation. Validation is so much more than a regulatory hurdle. Validation gives you confidence that an assay will yield reliable results that can be trusted to make critical decisions for advancing drug candidates or evaluating clinical efficacy.

Immunotherapy research is a rapidly expanding field with a pipeline of monoclonal antibodies in development to treat a range of cancers and autoimmune diseases. The mechanism of action (MOA) used by an antibody to mediate a therapeutic response must be fully defined to enable a candidate antibody to advance down the preclinical development pipeline. It is also required for all antibodies used in clinical research and regulatory IND filings in order to optimize dosing and assess the risk of detrimental side effects.