KCAS established our Clinical Sample Kitting team in the early 1990s in response to shortcomings we observed in the collection techniques in trials where we were providing bioanalytical support. As the group has evolved, our aim has been to provide the flexible, custom service that…

After an open call that went out earlier this year, Shane De Büchel, Sr Manager of Quality Assurance (Compliance & Systems) at KCAS, has been selected as one of roughly 50 members of the Society of Quality Assurance to collaborate in authoring an upcoming data integrity book (the…

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…

Dawn Dufield, PhD, Senior Director of Biopharmaceutical LC-MS/MS Services at KCAS, has been invited to lead a workshop discussion session on Lipidomics at an upcoming Gordon Research Conference from August 7-12 in Newry, ME. The event will be a week long conference highlighting recent developments in standardization, omics integration,…

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…

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…

Originally produced by Xtalks on Friday, April 22, 2022 | 12pm EDT (NA) / 5pm BST (UK) / 6pm CEST (EU-Central)  60 min Webinar Description: Due to the relative maturity of the technology, most people’s instinct when thinking about bioanalysis of large molecules is towards ligand binding assays.

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…

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.

Many flow cytometry users are happy to start an experiment with a general protocol and a question about their specimen -- Will my cells make more cytokines or express more markers after activation? Will my cells respond to a novel immunotherapeutic drug candidate?

Have you ever wondered why certain experiments are done under GLP (good laboratory practices) conditions? GLP is a term that is used frequently in preclinical research, and are a set of guidelines that act as a management control for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemicals (including pharmaceuticals) for non-clinical safety tests[1]. Sometimes it’s hard to understand when and why protocols must be done under GLP conditions. In general, GLP conditions must be maintained when an experimental drug or biologic may be used ultimately in humans and will need to be evaluated by regulators like the FDA.