Animal health programs have consistently been supported by KCAS with increasing study complexities although they have constituted a small percentage of the overall pharmaceutical development, these programs have consistently been supported by KCAS with increasing study complexities. ANIMAL HEALTH – LABORATORY SUPPORT KCAS is not only centrally located in…

The bioanalytical landscape for support of biopharmaceuticals (biologics or large molecules) and biomarker testing is an ever changing map. The industry is currently focused on low level sensitivity, data integrity, and compliance with the…

Protein characterization is a broad term describing the profile or fingerprint of a large molecule’s (or biologic’s) physical, chemical, and biological properties. Characterization of the protein will test the purity, activity, and the quantity…

If you’re running a clinical or preclinical study, there are many components that you need to think about, plan, and execute. One is “what the heck do I do with these samples we’re collecting”…

Adoption of technology has a life cycle that typically follows a bell-shaped curve. There are early adopters, early majority, late majority, and laggards. Adopting technology early comes with a risk, as not all technologies are widely adopted and many are very short lived. Adopting late also comes with a risk,…

As the Bioanalytical support for drug development continues to grow, more and more scientists are requiring more complex assays. Two examples are cell based assays and what we refer to as live cell assays.

The FDA has regulated cigarettes, smokeless and loose tobacco since 2009 under the Tobacco Control Act. In 2016, the FDA finalized a rule for the regulation of all tobacco products, making it illegal to sell e-cigarettes, cigars and hookah tobacco to anyone under 18 and requiring retailers to check photo…

Immuno-oncology is a growing field. The goal is to augment the patient’s immune system to attack the cancer cells. The current lines of treatment for cancer are radiation, chemotherapy, and surgical resection. If these treatments do not work, physicians can seek alternative treatments, such as immune-oncology therapeutics. Two emerging immune-oncology…

Once again we find ourselves wrapping up our 2017 goals and  and tallying the year’s performance. Simultaneously, we are filled with excitement looking forward to the New Year and to the promises it will bring to the pharmaceutical industry and the CRO community. According to Reuters, 2017 was one of…

KCAS is the first GLP laboratory to qualify all 54 biomarkers offered as a V-Plex (Validated Plex) by MSD. The a la carte style allows for customization of panels that will fit the exact…

Several important classes of drugs are inherently unstable in biological fluids. Examples include alkylating agents, cytostatic nucleosides, drugs with ester, aldehyde, thiol, nitroxyl or lactone functional groups, and small molecule compounds with unstable metabolites, such as acylglucuronides. The rate at which an analyte degrades in blood, other biological fluids, or…

The 505(b)(2) drug development path, in contrast to traditional development of a new, never been approved drug (described under 505(b)(1) of the Federal Food, Drug, and Cosmetic Act) or ANDA (described under Section 505(j) of the Act) for a generic drug that is no longer under patent…