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Drug discovery is an essential part of the drug development process. Testing in drug discovery is the mechanism to provide drug candidates that are selected for regulated animal studies and hopefully moving into clinical trials. Bioanalytical drug discovery includes a wide range of tests including assessment of a compound’s physiochemical...
Biomarkers can be defined and utilized for many purposes. There are disease biomarkers as well as mechanistic or pharmacological biomarkers. To reduce attrition and better understand a therapeutic, it is essential to be able to monitor the effectiveness of the therapeutic during drug development. Measurement of biomarker levels related to...
I have been studying Biological Markers (biomarkers) for over 25 years, but last 5 years they have exploded and become a key bioanalytical component to a drug's success. Biomarkers are used to support drug submissions, but the term can mean a very wide range of things including something as standard...
The workflow for bioanalytical LC-MS/MS requires isolation of analytes of interest from biological samples prior to analysis. This usually involves an extraction procedure ahead of injection into the LC-MS/MS system where the target compounds are separated from other analytes & potential matrix co-extractants. Addition of an internal standard at a...
To read part one of this 2-part series, click here. With increasing focus on large molecule therapeutics and interest in large molecule biomarkers it’s essential to have LC/MS available as a complimentary technology to ligand binding approaches. LC/MS can often provide enhanced selectivity when ligand binding methodologies see interferences...
A recent trend in the pipelines of pharmaceutical companies & biotechs has been a shift to large molecule therapeutics. This presents a challenge for bioanalysis by LC/MS because the molecular weights of the target analytes are well beyond the mass range of the mass spectrometer. Electrospray (& ion spray)...
Join us Tuesday November 10, 2020 at 11am EST| 8am PST| 4pm CET| 5pm CET Bioanalytical liquid chromatography–mass spectrometry (LC–MS) for small molecules is often referred to as a routine technology. That perception may be true for many drugs, but as pharmaceutical companies move into new areas,...
Dose Formulation Analysis is an essential step in regulated nonclinical studies to assure that correct doses have been administered to underpin toxicokinetic assessments. Based on years of experience, KCAS has built a stand-alone team dedicated to dose form analysis. We recognize that robust analytical methods, rapid turnaround, and efficient communication...
The Biotherapeutics industry is rapidly modifying and developing new Biotherapeutics into complex molecules with multi-functional domains for specific biological functions. Immunogenicity testing is now mandatory part of any Biotherapeutic development. Immunogenicity is the ability of an antigen or epitope to elicit an immune response in the body of an...
If you missed our webinar on April 22nd of 2020, you can check it out below! Often, when confronted with outsourcing and looking for laboratories for your discovery projects, turnaround times and cost are two very important factors. Quality and reliability of data generated are of course essential as well. How do...
John Pirro joins KCAS as Senior Director of Ligand Binding Assays Services. He is responsible for all Ligand Binding Assays, PK, ADA and Neutralizing Antibody assays. He will be assisting clients in directing assays for submission to FDA and EMEQ and working with clients as well as our internal KCAS...
Thank you for your interest in learning about KCAS. Founded in 1979, KCAS has become one of the fastest growing Bioanalytical and Biomarker facilities within our industry. KCAS is a progressive growing contract research organization of over 150 talented and dedicated individuals committed to our mission, “KCAS provides reliable and...
KCAS Webinar Archive: “What’s Been Happening in Pharma & Biopharma that is NOT Related to COVID-19?”
If you missed our webinar on May 29th about all things noteworthy within the industry and at KCAS which is NOT related to COVID, you can check it out below! 2020 has seen a major shift in our business environment as the world works to deal with the...
To view/listen to the latest episode of our "2-Minute Tuesdays" click below! Along with our all-new Podcast, "The Weekly Bioanalysis", KCAS is proud to introduce a new weekly series of 2-minute videos featuring our Senior Scientific Advisors. We're calling them "2-Minute Tuesdays"! These quick videos are an opportunity for all of...
For years, KCAS has considered incorporating a number of creative communication tools and solutions to engage with our clients and ensure information about our services are reaching the attention of those who need them. Among the discussions, the idea of a Podcast has come up often, but for one reason...
As nations and states deal with the effect of a global pandemic, this has translated to a thorough test of industries and businesses. KCAS has been designated as an essential business by nature of our role in supporting the development of life-changing medications. We have had to focus on maintaining...
The long-term economic consequences of the COVID-19 virus are yet to be determined. However, short term it is having major impact on research & drug development so companies are adapting in order to survive. Many of our clients are engaging us much earlier in the bioanalytical process while they work...
Some clients share with us that what keeps them up at night is how much of their projects (and what type of platforms/technologies) their bioanalytical lab can reliably perform. Some clients invest years of time in engineering & characterizing reagents, researching sample storage & transportation, and performing the methods -...
Biomarkers can be defined and utilized for many purposes. There are disease biomarkers as well as mechanistic or pharmacological biomarkers. To reduce attrition and better understand a therapeutic, it is essential to be able to monitor the effectiveness of the therapeutic during drug development. Measurement of biomarker levels related to...
Wednesday, April 22, 2020 | 12pm EDT (NA) / 5pm BST (UK) / 6pm CEST (EU-Central) 60 min Often, when confronted with outsourcing and looking for laboratories for your discovery projects, turnaround times and cost are two very important factors. Quality and reliability of data generated are of course essential as well. How do...
Pharmacokinetic modeling during the drug development process is essential for determining whether an administered drug substance has the necessary characteristics to meet its intended medical use. Typically for small molecules, this is based on time/concentration data generated from biological samples following analysis using LC-MS/MS. One of the principal challenges...
Even before the President’s announcement on Friday, KCAS was receiving calls from customers and colleagues with concerns about the way the world’s recent health and safety concerns would affect business continuity. Rapidly changing updates over the last few weeks about the way everyone should handle these trying times have led to...
There is a new and growing focus on drug development at KCAS. Our clients - both pharma and biotech research organizations - have depended on KCAS to provide bioanalytical services for over four decades. We call this new focus a “Powder-to-Report” approach. KCAS is unleashing its dedicated Discovery group,...
Friday, February 28, 2020 | 12pm EST (NA) / 5pm GMT (UK) / 6pm CET (EU-Central) 60 min There are many bioanalytical contract research organizations (CROs) that will provide quality bioanalytical services for a single project or perhaps even a single program for support of drug development. But how does a biopharma company trust...
What level of regulatory oversight is needed for bioanalytical flow cytometry in support of drug development, specifically cell and gene therapies? Drug development is dependent upon robust and reproducible bioanalytical results. In 2017 the first FDA approved, commercially available cellular therapy in the United States, Novartis' Chimeric antigen receptor...
Biomarkers are key drivers in the drug development process. Frequently, developing a panel of biomarkers to test a particular mechanism or hypothesis is critical to the success of a drug. At KCAS, we develop assays for custom panels or individual biomarkers based on client needs and can also assist with...
Dose Formulation Analysis is an essential step in regulated nonclinical studies. Robust analytical methods, rapid turnaround, and efficient communication helps ensure the dose form results for your GLP studies are delivered on time. At KCAS, our scientific expertise allows us to develop methods that achieve your study requirements. Our...
KCAS is a solution-based company. We are focused on the delivery of high quality scientific and defendable data, able to meet or exceed client’s timelines and expectations. One of the main reasons we are able to deliver on even the most challenging projects and programs, is the technical breadth and...
How will your background in science play a role in your new Senior Scientific Advisor position? I feel that my skill set has evolved consistently since my graduate degrees where I’ve learned different yet complimentary lessons about data presentation, data interpretation, marketing, customer partnering, optimizing operational processes, customer management and...
At KCAS, our Discovery group performs bioanalytical / biomarker method development that can include any of the various components required for a validated method under the GLP guidelines. So why is Discovery group needed? The beginning stage of drug development is a stage of trial and error. It is generally...
Biomarker is a broad term and can mean so many different things depending upon the scientific discipline. For Bioanalytical biomarker analysis - and specifically for CROs equipped with 9 different platforms to measure biomarkers and a cell culture suite with up to 19 color flow cytometry all under one roof...
KCAS is a progressive growing contract research organization with dedicated groups in pharmaceutical services to perform early stage discovery rapid method development and analysis, as well as, regulated preclinical and clinical phases, with support offered through NDA submission. We have an arsenal of top of the line instrumentation with a...
Original Time and Date of Webinar: Thursday, May 30, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST Event Overview: In this webcast, learn how the FDA Bioanalytical Method Validation Guidance (May 2018), the FDA Immunogenicity Testing of Therapeutic Protein Products (January 2019), and the February...
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...
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...
Biomarker are key drivers in the drug development process. Frequently, developing a panel of biomarkers to test a particular mechanism or hypothesis is critical to the success of a drug. At KCAS, we develop assays for custom panels or individual biomarkers based on client needs and can also assist with...
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...
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...
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...
Samples in your freezer that still need to be tested? Assays not performing as expected? Boss looking for answers?? Many of our clients come to us because other CROs have provided meaningless flow cytometry PD assay results. This could be due to poor panel design, inability to compensate correctly,...
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....