Blog

Although bioanalysis is KCAS’ principal area of expertise, we are always considering how we can build around those capabilities to ensure that we can provide optimal service for our clients. Our current breadth of service enables us to provide a comprehensive approach during non-GLP pre-clinical studies where it is feasible...

KCAS has some of the best customers in the world, and during this special time of the year, we want to make sure you know how much we appreciate you. We hope your holiday season is full of health and happiness during time with friends and family. We wish you...

As most Americans were wrapping up their Thanksgiving and Black Friday rituals just a few weeks ago, many felt the corner had finally been turned on COVID and we would all be able to start finally getting back to normal... instead, within days, we were all greeted with news about...

As a service organization, KCAS works to be as collaborative as possible to help our clients during the drug development process. For us, the personal touch is integral to building solid business relationships. Having to rely on email and on-line meetings can’t really compensate for the ability to chat beyond...

Recently, KCAS's Senior Director of BioPharma Services, Jeff Hester, PhD, was invited by Bioanalysis Zone to discuss key developments in the emerging field of Cell & Gene Therapy products (CGT). Along with other industry opinion leaders Stephanie Pasas Farmer, PhD (Ariadne Software, KS, USA) and Boris Gorovits, PhD (Sana Technology,...

Although the world now has a number of vaccines in place and available to serve as a preventative and/or impact-reduction method for COVID, there are a number of reasons that it is also important for the Pharma and Biopharma industries to continue developing other treatment and medicines to for those...

Immunogenicity risk assessment has grown as a significant part of Protein therapeutics for Pre-Clinical and Clinical testing for regulatory submissions. Based on this, it is the requirement of CROs, who provide clients with Immunogenicity assays and data, to keep abreast of any changes or interpretations of the FDA Guidance’s as...

Data can be the most important aspect of a GxP organization. Storage complexity and requirements are increasing, and cloud solutions can be an attractive option for maintaining this ever-growing pool of data. When considerations are addressed, organizations can find ways to safely and effectively embrace these cloud solutions to increase...

It's an extra special episode of "The Weekly Bioanalysis" as Dom and John celebrate the 50th EPISODE of the official KCAS Podcast by greeting you LIVE in front of the cameras in person for the first time! As usual, they discuss the news, the industry, and other topics like their...

With the current events and schedules constantly changing – we are happy to announce we will still be attending AAPS PharmSci 360 in-person this year. Furthermore 2 of our SSA’s will be participating in scientific panel discussions. Below is a brief snippet of what you can expect from each panel....

Sonia Hall, PhD, the CEO of BioKansas, joins Dom and John as our guest for the 49th episode of "The Weekly Bioanalysis". Among a litany of topics, Sonia takes the time to tell the guys about all the amazing things BioKansas does and she gives a breakdown of the many...

As a Senior Director for Discovery in the pharma division at KCAS, I would like people to think of “Bioanalytical Discovery” as a stage in drug development; one where you are doing your final experiments and pilot studies before advancing to a GLP pre-clinical state. Also I would like people...

This episode Don and John thought they would talk about something near and dear to our hearts here at KCAS - Antibody-Drug Conjugates. Increasingly we’ve all experienced talk about ADCs everywhere being approved and for various conditions - mostly oncology (drugs used in the treatment of cancer). And of course...

When I’m asked about the best way to go about selecting a CRO, my mind goes back to my second day at Magellan Laboratories in 1999 when I started my career years ago in this business. I had a customer who told me what it would take to be a...

One of the biggest questions on so many people's minds since the beginning of 2020 has been "how long will it take for an official vaccine to be approved by the FDA?". It seems the answer has arrived in the form of the approval by the FDA for Pfizer's COVID-19...

The benevolent COVID virus has brought our industry many “gifts.” One birthday present is like a jelly of the month club subscription, and it’s impacted all Central Labs and providers of Clinical Sample Collection Kits, without discretion: the shifting un-availability of important kit contents, like vacutainers and polypropylene tubes.  ...

Dom and John have had a busy summer, and due to recent pressing issues, episode #46 of “The Weekly Bioanlaysis” is an abbreviated version, focusing only on a review of recent news and resources within the industry. Our next episode #47 will focus on the recent announcement that Pfizer’s COVID...

What is Hybrid LC-MS/MS? Technically Hybrid LC-MS/MS is a technique that combines an affinity capture step with LC-MS/MS detection. Usually it only requires one antibody, whereas a typical LBA technique will require two. Following affinity capture, it is common to include a digestion step to produce surrogate peptides, which are...

Dom and John often like to feature each of the groups within our industry that contribute to the success of the team, and recently, one of those groups that they were asked about was Program Management. Both of them see first hand the benefit of having a dedicated program management...

Although small molecules represent the majority of compounds in development as drug candidates, there is an increasing tendency to more complex molecular structures to address unmet molecular needs. This has been reflected in the types of molecules that the LC-MS/MS Discovery team at KCAS has increasingly been working with. This...

A number of COVID variants have popped up throughout the life of our podcast, but we're all hearing more and more stories coming out about the struggles and new challenges surrounding the Delta variant. Despite the encouraging rise in the number of vaccinated, a number of countries have seen an...

Thursday 29 July 2021 • 07:00 [PST] 10:00 [EST] 15:00 [BST]   This webinar will discuss common challenges in dose formulation analysis during a toxicology study and will present several case studies on how to overcome these challenges.   During the webinar, our experts will discuss a typical timeline of a...

Apologies from the Producer for the shorter length of this episode. We had planned to air a recorded podcast episode on a topic we already knew had the potential to become somewhat controversial, but as the news on this topic progressed between the time of recording and publishing of this...

In its simplest terms, Dose Formulation Analysis (DFA) verifies all solutions used in preclinical toxicology studies. For FDA IND applications, dose formulation analysis is critical. Some companies are unfamiliar with the DFA process or have questions about what to expect. Below are typical questions concerning Dose Formulation Studies:   Do...

As more and more of America (and others around the world) become fully vaccinated, there are still many questions from everyone, regardless of whether they have been vaccinated. For the 42nd episode of "The Weekly Bioanalysis" podcast, Dom and John discuss many of these questions by giving a sort of...

It was early March 2020, the tendons in my right hand were swollen and throbbing, and I was seeking to learn more about off-the-bench careers at CROs and finally retire from pipetting. A few days before, I’d registered for a webinar on gender parity in STEM and I was excited...

During episode #41 of "The Weekly Bioanalysis", Dom and John discuss the often sensitive topic of the need for regulation and oversight within the pharma and biopharma industries during testing, manufacturing and clinical trials. The evidence for these things has been made clear many times over the years, but even...

Tissue and Non-Liquid Matrices (such as cell lines, red blood cells, PBMCs, bone marrow aspirates, and suspension cells) are valuable matrices[] to test for biomarkers (PD) and drug levels (PK). Testing of tissues and non-liquid matrices are critical for support of small molecule, large molecules, and cell and gene therapies....

2020 had an impact on nearly every industry around the world in 2021, with effects that will likely continue to ripple well into 2022 and possibly the years beyond. Arguably one of the industries that saw the largest shifts related directly to the events of 2020 were the Pharma and...

A recent trend observed at KCAS is that the bioanalytical needs of our clients’ projects are becoming more complex.  There is increasing focus on monitoring delivery of therapeutics to the target of interest. This widens the scope of bioanalytical assays beyond typical plasma or serum methods. We are seeing increasing...

During episode 39 of "The Weekly Bioanalysis", Dom and John are joined by one of our KCAS colleagues, Mallory Jolly. Mallory is our newest Business Development Representatives, and while she has an extensive background within the industry, she found it occasionally difficult to describe the nuances and particulars that set...

There has been an increasing focus on large molecule therapeutics and pharmaceutical companies have increasingly aligned their development pipelines in that direction. This has resulted in more biological therapeutics coming to market.  Last year, in 2020, 15 of the 53 new approved drugs were large molecules.   Historically, bioanalytical support...

There are SO many conversations being had about Vaccines right now. In fact its difficult to find a social media stream that doesn't include at least one photo of someone's recently stamped vaccine confirmation paperwork. Everyone is asking "Which one did you get?", "When will my final dose take its...

Pharmacodynamics (PD) is defined as the study of the biochemical and physiological effects of drugs and the mechanisms of their actions. Where pharmacokinetics looks at how the organism processes the drug, pharmacodynamics studies how a drug affects the body organism. As bioanalytical scientists we are generally focused on the extent...

      Webinar Date and Time: Friday, April 23, 2021 @ 12pm – 1pm EDT   There has been an increasing focus on large molecule therapeutics and pharmaceutical companies have increasingly aligned their development pipelines in that direction. This has resulted in more biological therapeutics coming to market.  In...

During episode 37, Dom and John are joined by Stephanie Pasas-Farmer, Founder and CEO of Adriadne Software, as we look back over the things our industry has learned about the limitations of the Drug Development Process during COVID. Stephanie and John Pirro, Sr Director of LBA Development at KCAS, discuss...

Pharmacokinetics (PK) is defined as the branch of pharmacology dedicated to determination of the fate of substances administered to a living organism.   Pharmacokinetics refers to the movement of drug into, through, and out of the body—the time course of its liberation, absorption, distribution, metabolism, and excretion (ADME).   Liberation...

During the 36th episode of “The Weekly Bioanalysis”, Dom and John touch on something they really haven't yet throughout the course of our podcast - the impact of trends within the drug development industry on consumer costs. There is a very clear course most drugs take throughout their process, but...

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...

On the heels of vaccine production and distribution over the past month or so, there has been a lot of talk in the news about Covid variants and what this might mean for infection rates, vaccine implications and what might be next in terms of therapies and treatments. Dom and...

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...

Ever since the first Covid vaccine was approved just a few weeks ago, vaccine news has been everywhere. But as the FDA issues more and more authorizations and nationwide vaccination gets underway, Dom and John take some time during the 34th episode of "The Weekly Bioanalysis" to discuss the Top...

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...

For episode #33 of the "The Weekly Bioanalysis" Podcast, Dom and John kicked the new year off by discussing the effect COVID had on our industry in 2020, and they shared their predictions for Drug Development in 2021 (both COVID and Non-COVID related).   To view/listen to the episode of "the...

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...

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...

Join us Friday, July 10, 2020 | 12pm EDT (NA) / 5pm BST (UK) / 6pm CEST (EU-Central) 60 min       The field of quantitation of large molecules or proteins has been around for a long time. Typically, ligand binding assays (LBA) have dominated this area. However, the use...

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...

Join us at 11am EST on May 29th, as our KCAS Senior Scientific Advisors, John Perkins and Dominic Warrino, discuss all things noteworthy within the industry and at KCAS... that is, which is NOT related to COVID!     2020 has seen a major shift in our business environment as...

KCAS is positioned to assist in the monitoring of patients during and after the peak of infections are observed.  We have a wide array of platforms and techniques we can apply to your samples.   We can help in the current environment by monitoring the status of the immune system...

To view/listen to the latest episode of "The Weekly Bioanalysis" click below!     Thank you for checking out our podcast! This is where you will find the latest episode of "The Weekly Bioanalysis" and if you let it continue playing, you will be able to watch and listen to...

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...

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...

Just a few short days ago, nobody could have conceived the level of disruption that we would have to endure in the way we work and live for the next several weeks. The rapidly changing COVID-19 challenge is accelerating our need to adjust and adapt to keep our health and...

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...

In our daily life we interact with many different people who help us by applying their expertise to deliver things we would otherwise struggle with. Often the differentiator for us, as consumers, is how we feel we’ve been treated by the people who are working on our behalf. The first...

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...

      As the field of oncology has evolved, the toxicity of therapeutic agents has driven the development of drugs that target and kill tumors compared to more general therapies that can also impact healthy cells. Principal amongst these therapies is the use of antibody-drug conjugates (ADCs) that are...

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...

Have you ever wished you could tailor your project to your research needs instead of taking what you can get from a CRO?  Here at KCAS, our Discovery team prides itself on having the flexibility to meet client’s needs by designing the experiments with feedback from our sponsors. Our team of...

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...

The paradigm of drug development outsourcing is in a period of rapid transition coupled with a growing market in a competitive space. Today’s service providers are hardly recognizable from a decade ago and if the continued evolution in the market is any indicator, it is safe to say the next...

Everyone likes to claim they offer fast turnaround times, but clients often come to KCAS having been burned by the lack of timeliness on their Discovery projects. At KCAS, we incorporate our clients’ priorities at the top of our priorities. We have put together a Discovery team with decades of...

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...

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” – especially if they’re rare or limited. But even if samples are not rare or limited,...

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.   Typically a cell based assay requires culturing of cells for several days prior to being...

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...

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 needs of a study. Additionally, KCAS can perform fit-for purpose GLP validation of any of these...

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,...

Want to meet our presenting author, a business development representative or a senior scientific officer? Send us a note to set up a meeting   Find KCAS We are located at booth 2424 marked by an orange star KCAS' Poster Presentations Tuesday, November 14, 2017 Noon - 1:00 PM  ...

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...

Tissue and tumor sample testing are valuable matrix to test for drug levels (PK) and biomarkers (PD). They are understudied in my opinion as far too many studies result in no data or uninterpretable data. The root cause is a break down in how the tissue was collected, processed, and...

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...

Like the old adage, “you get out of it what you put into it,” good study design is a prerequisite of good data. To boost the chances of generating accurate and informative facts over the course of a study, it is key to consider all of the supporting parameters that...

Finding a laboratory to successfully transfer and GLP validate your PK method can be a challenge. Yes sure the big labs can do it, but if you are not a preferred provider you may find yourself working with the B team that doesn’t move as fast as you need, and...

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...

With qualified methods for measuring up to 30 biomarkers, KCAS is ready when you are!   Biomarkers are not new, nor are there a shortage of labs to provide testing. However, finding a CRO that can produce defendable data is not as easy as it sounds. KCAS Bioanalytical and Biomarker Services...

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....