Shawnee, KS, United States
Shawnee, KS, United States

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Khan M.U.,KCAS Inc | Bowsher R.R.,B2S Consulting | Cameron M.,LUMIGEN | Devanarayan V.,Abbvie Inc. | And 9 more authors.
Bioanalysis | Year: 2015

Increasingly, commercial immunoassay kits are used to support drug discovery and development. Longitudinally consistent kit performance is crucial, but the degree to which kits and reagents are characterized by manufacturers is not standardized, nor are the approaches by users to adapt them and evaluate their performance through validation prior to use. These factors can negatively impact data quality. This paper offers a systematic approach to assessment, method adaptation and validation of commercial immunoassay kits for quantification of biomarkers in drug development, expanding upon previous publications and guidance. These recommendations aim to standardize and harmonize user practices, contributing to reliable biomarker data from commercial immunoassays, thus, enabling properly informed decisions during drug development. © 2015 Future Science Ltd.


PubMed | Womens Health Research, Minnesota Gynecology & Surgery, The Saints, Mercy Hospital and 10 more.
Type: Journal Article | Journal: Journal of minimally invasive gynecology | Year: 2016

To assess the safety and effectiveness of the Minerva Endometrial Ablation System for the treatment of heavy menstrual bleeding in premenopausal women.Multicenter, randomized, controlled, international study (Canadian Task Force classification I).Thirteen academic and private medical centers.Premenopausal women (n=153) suffering from heavy menstrual bleeding (PALM-COEIN: E, O).Patients were treated using the Minerva Endometrial Ablation System or rollerball ablation.At 1-year post-treatment, study success (alkaline hematin 80mL) was observed in 93.1% of Minerva subjects and 80.4% of rollerball subjects with amenorrhea reported by 71.6% and 49% of subjects, respectively. The mean procedure times were 3.1minutes for Minerva and 17.2minutes for rollerball. There were no intraoperative adverse events and/or complications reported.The results of this multicenter randomized controlled trial demonstrate that at the 12-month follow-up, the Minerva procedure produces statistically significantly higher rates of success, amenorrhea, and patient satisfaction as well as a shorter procedure time when compared with the historic criterion standard of rollerball ablation. Safety results were excellent and similar for both procedures.


PubMed | Ampersand Biosciences LLC, LGC Ltd, Quintiles, Pfizer and 7 more.
Type: Journal Article | Journal: The AAPS journal | Year: 2016

Multiplex ligand binding assays (LBAs) are increasingly being used to support many stages of drug development. The complexity of multiplex assays creates many unique challenges in comparison to single-plexed assays leading to various adjustments for validation and potentially during sample analysis to accommodate all of the analytes being measured. This often requires a compromise in decision making with respect to choosing final assay conditions and acceptance criteria of some key assay parameters, depending on the intended use of the assay. The critical parameters that are impacted due to the added challenges associated with multiplexing include the minimum required dilution (MRD), quality control samples that span the range of all analytes being measured, quantitative ranges which can be compromised for certain targets, achieving parallelism for all analytes of interest, cross-talk across assays, freeze-thaw stability across analytes, among many others. Thus, these challenges also increase the complexity of validating the performance of the assay for its intended use. This paper describes the challenges encountered with multiplex LBAs, discusses the underlying causes, and provides solutions to help overcome these challenges. Finally, we provide recommendations on how to perform a fit-for-purpose-based validation, emphasizing issues that are unique to multiplex kit assays.


The 9th GCCClosed Forum was held just prior to the 2015 Workshop on Recent Issues in Bioanalysis (WRIB) in Miami, FL, USA on 13 April 2015. In attendance were 58 senior-level participants, from eight countries, representing 38 CRO companies offering bioanalytical services. The objective of this meeting was for CRO bioanalytical representatives to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues selected at this years closed forum include CAPA, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, and ELNs. A summary of the industrys best practices and the conclusions from the discussion of these topics is included in this meeting report.


King L.E.,Pfizer | Farley E.,Quintiles | Imazato M.,Novartis | Keefe J.,Biogen Idec | And 4 more authors.
AAPS Journal | Year: 2014

The L4 Global Harmonization Team on reagents and their stability focused on the management of critical reagents for pharmacokinetic, immunogenicity, and biomarker ligand binding assays. Regulatory guidance recognizes that reagents are important for ligand binding assays but do not address numerous aspects of critical reagent life cycle management. Reagents can be obtained from external vendors or developed internally, but regardless of their source, there are numerous considerations for their reliable long-term use. The authors have identified current best practices and provided recommendations for critical reagent lot changes, stability management, and documentation. © 2014 American Association of Pharmaceutical Scientists.


KCAS Inc | Entity website

Your success is our mission. KCAS is committed to providing best-in-class bioanalytical services through uncompromised attention to quality ...


KCAS Inc | Entity website

KCAS has a diverse staff of 55 employees with an average tenure of 14 years. Many of our researchers, including 10 PhDs, are recognized as leading experts in their field ...


KCAS Inc | Entity website

KCAS offers custom and kit-based services for quantifying cytokines, chemokines and other biomarker in animal or human matrices. Our team of scientists use ELISA, RIA or electrochemiluminescence (ECL)-based assays to perform the bulk of our biomarker work, although other platforms, such as LC-MS/MS are available ...


KCAS Inc | Entity website

12400 Shawnee Mission Parkway Shawnee Mission, KS 66216 (913) 248-3000 *protected email*

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