Blog
Incurred Sample Reanalysis (ISR) has become a process check for a bioanalytical method’s performance and should be a routine step in the process of developing a new method. More importantly, having a low Incurred Sample Reanalysis (ISR) failure rate from your Contract Research Organization (CRO) is important for several reasons: It shows repeatability and robustness of...
Let’s face it… we work in a crazy industry. Nobody who has spent any significant portion of their career within it would deny that the global pharmaceutical & biopharmaceutical industry is a sometimes volatile one - with many opportunities, but also several unexpected “hazards” along the way. The market...
How confident are you in your CRO’s support of your drug discovery program? Maybe you should take a closer look... Support of drug discovery programs is essential in providing integrated drug development services. The key is having the expertise to also be able tackle not only complex matrices but any...
At KCAS, we work with Director, VP, and C-level pharmaceutical and biotech executives that need to measure their drug or the effect of their drug in biological matrix. Many of our customers rely on us to help design a strategic bioanalytical plan: a purposeful approach that flexes depending on regulatory...
Immunoaffinity LC-MS/MS or hybrid LCMS is an approach that has been gaining a lot of traction in the past several years. The technique allows one to quantitate low level analytes (proteins or peptides in many cases) with exquisite selectivity and sensitivity. Many pharmaceutical companies are trying to expand their expertise...
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 new FDA guidelines that regulated bioanalysis must keep up with. While attending the 2018 Workshop...
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 of the protein. Methods for quantification include chromatography methods such as high-performance liquid chromatography (HPLC) or...
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,...
The FDA has not approved marijuana for any indication, as it continues to retain Schedule I designation. However, a key component of marijuana (D9-Tetrahydrocannabinol or THC) and several synthetic analogues have been approved by the FDA or are under clinical investigation. Whether the FDA will consider approving marijuana in the...
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...
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,...
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 protection, is an...
Designing a tissue assay in accordance to the FDA bioanalytical method validation (BMV) guidance involves three key questions. First, can control tissue be easily obtained in bulk quantities or should a surrogate tissue approach be considered? Second, what sample processing procedures should be considered relative to the known stability of...
Measuring new biotherapeutic modalities such as cellular therapies are not well defined in the regulatory landscape. Currently no white papers or guidelines are available to help navigate the murky waters of quantifying new modalities, which is why the AAPS PK focus group has set a course toward providing the field...
In pursuit of KCAS’ Mission to provide reliable and defendable data, quality is one of our core values. It is the responsibility of every employee to provide an always improving, high-level performance in all we do. Our independent Quality Assurance Unit (QAU) assures management that Operations is performing in conformance...
Immunogenicity, why do we keep talking about it? Immunogenicity can, in the simplest of terms, be described as a subject’s ability to generate antibodies specific to the dosed protein therapeutic. While stating it this way understates the complexity of the immune system and the methods needed to detect and characterize...
Surprisingly, there are a number of drug development companies that do not obtain stable isotope-labeled internal standards (SIL-IS) for their bioanalytical methods. Instead they settle for using a surrogate internal standard (a compound that closely resembles the measured analyte) which can lead to unreliable data and be detrimental to a...
What you don’t know about how an off-the-shelf Biomarker kit is evaluated and qualified can significantly compromise your biomarker data. Running the kit using the manufacturer’s instructions without systematically testing the accuracy/precision (A/P), range of quantification (ROQ), dilutional linearity (DL), stability, and selectivity can jeopardized the interpretation of the results. The...
There is regulatory requirement that the cumulative time a frozen pharmacokinetic sample has been thawed – from the time it’s removed from the freezer to the time it’s returned – be documented. Freeze/thaw cycle data is not deemed sufficient alone, since a study sample might have been thawed for extended...
Which anticoagulant is right for your flow cytometry analytes? The answer depends. That’s just one of the questions we address in the short video below. Watch on to learn about how we evaluated several anti-coagulants to determine epitope stability, permitting the use of remote collection agencies and shipping samples to...
It can often be difficult for women to make reliable judgements in estimating their menstrual blood loss. In addition, feminine hygiene products have dramatically changed to wick blood away from the surface, obscuring visual assessments. Both of these factors have a large impact in clinical trials, where menstrual blood loss...
The challenges and obstacles to including flow cytometry in multi-center clinical trials are well-known. The solutions the KCAS team offers can eliminate risks commonly associated with lost or delayed shipments and allow for batching, which reduces the overall cost of conducting flow cytometric testing. As a result, our customers can...
The Department of Health and Human Services (HHS) has issued long awaited, comprehensive update on how medical research should be conducted. The Common Rule, 45 CFR 46 subpart A, issued 26 years ago and established basic protections for human subjects in research conducted by or supported by the HHS and...
The Simoa HD-1 Analyzer by Quanterix has broadened the detection of biomarkers to allow for screening of patient plasma, serum, or peripheral samples offering an advantage over more standard, and certainly more evasive, CSF samples. This has changed (and some might say revolutionized) the way scientists think about biomarkers. Neurodegenerative...
In May 2016, the FDA extended its authority to all tobacco products in an effort “to improve public health and protect future generations from the risks of tobacco use.” The Center for Tobacco Products (CTP), a branch of the FDA, now has regulatory authority over cigarettes, smokeless tobacco, e-cigarettes (electronic nicotine...
In today’s drug development arena, massive, multinational CROs dominate the industry. They offer a “one stop shop” suite of services covering Early Development to Phase IV Clinical Trials and everything in between. Although multinational CROs are the powerhouse of drug development, their size limits their flexibility. Due to their...
Future submissions of data for nonclinical studies must now comply with the FDA’s recently published SEND guideline (Standard for Exchange of Nonclinical Data). This complex reporting format has resulted in a multitude of questions and concerns from our customers planning GLP animal studies. Has your organization begun a dialogue with your CRO...
A study was recently published reviewing the safety and efficacy of the Minerva Endometrial Ablation System. The Minerva Endometrial Ablation System is the first device to be evaluated and approved by the FDA using the new Objective Performance Criterion control. A major strength of this study was the use of...
KCAS has engaged and recruited a world class Advisory Council to work closely with the KCAS leadership team. KCAS is committed to cultivating expertise and increasing capacity to support the industry’s needs for a mid-size functional service CRO with the proficiency to serve small and mid-size pharmaceutical and biotech organizations....