Therapeutic Area - Orphan/Rare Diseases Solutions
The study of drug development for orphan and rare diseases is a very important, but highly specialized part of our industry. Not every bioanalytical CRO offers these services, and even those who do, don’t necessarily do it extremely well. When you get into the cell and gene therapy areas, for instance, you’re dealing with rare diseases and immuno-oncology – those types of therapies have a more specific set of needs, from helping with clinical supply kits, through the whole chain of sample management – it takes a very specific set of skillsets and levels of experience that most CROs out there just don’t have.
KCAS has the history and expertise to handle your orphan and rare disease studies
There are a number of considerations when developing an assay to monitor a class of biomarkers. KCAS has validated an assay for 20 amino acids (20-plex) that has been applied to support studies in metabolism and rare disease. KCAS is interested in increasing our suite of biomarker assays. We are happy to develop and qualify custom methods or collaborate on more general assays for rare/orphan diseases.
KCAS Orphan/Rare Diseases Services
Antibody drug conjugates (ADCs) remain a popular oncology therapeutic modality. ADC analyses r…
The translation of an assay from Discovery to Preclinical/Clinical is an important part of dru…
Methods transferred into a new laboratory need to be re-established for regulatory compliance….
Affinity capture elution (ACE) is a method used in detecting ADA to increase the assay drug to…
Bioavailability (BA) is the percentage that a drug or its pro-drug form is absorbed into the g…
Cell based assays are highly specialized in vitro methods that can evaluate the functional and…
Cell based assays are highly specialized in vitro methods that can evaluate the functional and…
A significant number of drugs contain a chiral center that allows the compound to properly fit…
The accelerated pace within industry for quick “go / no-go” decisions in drug development, nec…
Flow cytometry is a technique used to detect and measure physical and chemical characteristics…
Hybrid LCMS is a technique which combines an enrichment step (typically an antibody enrichment…
All biotherapeutics will need to undergo immunogenicity assessment sometime in their drug deve…
Clinical Sample Kits at KCAS are more than just clinical supplies for the collection of PK sam…
At KCAS, methods are developed with a fit-for-purpose design in mind, based on our Client’s ne…
A fit-for-purpose approach is used by KCAS in method qualifications. Each method is designed t…
KCAS has extensive experience in validating methods in a wide range of bioanalytical platforms…
The discovery phase in drug development requires rapid and reliable data in making key decisio…
PD Analysis is the assistance with design, regulatory requirements and final data interpretati…
Biomarkers come in many favors. They can vary from serum/plasma analytes to the measurement of…
Pharmacokinetics (PK) is the determination of the extent of Absorption, Distribution, Metaboli…
Tissue bioanalysis is an essential area in understanding the extent of drug distribution, meta…