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New Case Study:
ALS Biomarkers Uncovered

EV-derived CNS biomarkers via NULISAseq™ CNS Disease Panel 120

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CRO for preclinical and clinical bioanalysis

KCAS Bio is a leading bioanalytical contract research organization (CRO) with a proven record of advancing drug development worldwide. We have provided bioanalytical development support for more than 315 approved drugs on the market, developed over 6,200 proprietary and non-proprietary assays, and successfully completed more than 20 FDA audits with no major findings.

As a top bioanalytical CRO lab, we continually invest in the latest instrumentation and combine this technical expertise with a consultative approach, ensuring our clients’ goals are achieved with confidence. Our teams also bring specialized expertise in advanced modalities, allowing us to support the evolving needs of modern drug development. By consistently benchmarking and optimizing our operations, we help scientific innovators and investors move forward with greater certainty.

With lab facilities across the US and Europe, along with a strategic alliance in Australia, we provide global sponsors with comprehensive services including bioanalytical, biomarker, immunogenicity, cellular and molecular assay capabilities, as well as clinical kitting and sample management.

Large Molecule Bioanalysis by LBA

Move your large molecule program forward with LBA strategies tailored to your development needs. With 20+ years of LBA experience, 60+ dedicated LBA scientists, and advanced platforms including NULISA, MSD, and Ella, KCAS Bio provides assay development, optimization, validation, and sample analysis support from early development through clinical studies.

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5000 Proprietary and Non Proprietary Assays Developed to Date.65 PhDs on Staff25 FDA Audits45 Years in Service4 World Wide Locations

Global biomarker and bioanalytical CRO lab

KCAS Bio is an established bioanalytical CRO with over 45 years of experience. We understand the human and financial impact of drug development delays. Through our unique approach to capacity planning, we combine the right experts with the right instrumentation to keep development moving smoothly. Our clients consider us a reliable partner because we strive to minimize downtime, avoid delays, and keep lead times as short as possible.

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What our clients say

We consistently earn our clients’ trust based on our reputation for transparency, delivering error-free data and keeping our promises.

I want to thank you for yet another great job on a clinical project. From study’s initial contract, to PK kits, to validation and analyses, and ultimately, the final data, all was excellent as always. Happy to work with you all and I look forward to future studies.
VICE PRESIDENT, BIOPHARMACEUTICALS COMPANY
I want to express my appreciation for the professional care and extra effort of the KCAS Bio validation team. It is very evident that these team members truly care about their work and continuously strive towards excellence. I am very grateful to all of them for a thorough review of the document set before, during and after validation. My job of software validation specialist takes me to GLP labs around the world. So, I can say with confidence, that the work done at KCAS Bio was exceptionally well-documented with appropriate detail so anyone could easily understand the steps taken to validate the software.
SOFTWARE VALIDATION SPECIALIST, LAB EQUIPMENT PROVIDER
They developed and validated a pharmacokinetics small molecule method for support of my dog GLP toxicology study. The KCAS Bio work was high quality, on time, within budget, and they had great/open communication.
FOUNDER & CEO, BIOSCIENCE COMPANY
How to Create an RFP for Bioanalytical CRO Services Blogs
Read article How to Create an RFP for Bioanalytical CRO Services

Selecting a bioanalytical CRO is an important decision in drug development, but the process begins well before proposals arrive. A well-structured request for proposal (RFP) gives a CRO the scientific and operational context they need to develop an accurate proposal. You may know what you need the data…

From Whole Blood to Dose Decisions: Managing a 3-Year, Multi-Continent Bioanalytical Program for a Phase 1a/1b Trial  Blogs
Read article From Whole Blood to Dose Decisions: Managing a 3-Year, Multi-Continent Bioanalytical Program for a Phase 1a/1b Trial 

When a sponsor’s biologic program expanded from a domestic Phase 1 design into a multi-region trial spanning New Zealand, EMEA, and APAC, the bioanalytical challenge centered on keeping a fragile, time-sensitive sample chain intact across nine additional clinical sites, two outsourced processing labs, and a central analytical lab, all…

Cross-Species Flow Cytometry in NHP, Minipig, and Dog: Will Your Immune Biomarker Data Translate to the Clinic? Blogs
Read article Cross-Species Flow Cytometry in NHP, Minipig, and Dog: Will Your Immune Biomarker Data Translate to the Clinic?

Here is a scenario we encounter regularly. A sponsor has a promising biologic, a T cell-engaging bispecific, a Treg-depleting antibody, or a checkpoint inhibitor with a novel target. The tox species are cynomolgus macaque, minipig, or dog. And the clinical team wants to know: what will we actually see…

Advancing great people and great science

We make nurturing new talent a strategic priority, so that teams are dynamic and constantly improving. We provide a supportive environment for continuous learning and training where you can become your best.

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We've earned our reputation for delivering reliable, error-free data. We understand the importance of speed, flexibility, and consistency and only make promises we can keep.

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