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Our globally integrated bioanalytical solutions ensure cost efficiency, accelerated clinical programs, and precise results across all phases of drug development.
CurexBio offers a full suite of integrated bioanalytical services, meticulously designed to meet the diverse and evolving needs of modern drug development programs. Our capabilities span the entire spectrum, ensuring scientific rigor and regulatory compliance:
The foundation of reliable bioanalytical data lies in robust analytical methods. We specialize in method development and validation, crafting highly specific, sensitive, and reproducible assays for the quantification of small molecules, biologics, and biomarkers in various biological matrices (e.g., plasma, serum, urine, tissue). Our validation processes strictly adhere to global regulatory guidelines (e.g., FDA, EMA GLP/GCP), ensuring the method’s fitness for purpose in terms of linearity, accuracy, precision, selectivity, recovery, and stability. This rigorous approach minimizes variability and maximizes data integrity.
With the support of pioneer technologies, primarily focusing on advanced LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry) platforms, our specialists performs detailed and precise sample analysis This powerful technique offers unparalleled sensitivity, selectivity, and speed, crucial for quantifying analytes at very low concentrations in complex biological samples. We ensure:
The bioanalytical data we generate is fundamental for comprehensive Pharmacokinetic (PK) and Pharmacodynamic (PD) support. By precisely quantifying drug concentrations over time, we help characterize a drug’s ADME profile, enabling sponsors to:
Biomarkers are increasingly pivotal in drug development, offering insights into disease progression, therapeutic response, and potential toxicity. CurexBio provides comprehensive biomarker analysis, developing and validating assays for novel and established biomarkers. This support aids in patient stratification, early efficacy detection, and personalized medicine approaches, accelerating decision-making throughout the development process.
For the development of biologics, assessing potential immunogenicity (the body’s immune response to a therapeutic protein) is critical. We offer specialized immunogenicity testing services, including screening, confirmation, and characterization assays for anti-drug antibodies (ADA), as well as neutralizing antibody (NAb) assays. This helps in comprehending the long-term safety and efficacy of biologic drugs.
Effective project management is key to seamless bioanalytical operations. Our experienced Bioanalytical Project Management team provides strategic oversight from study conception to final report. They coordinate between study teams, analytical labs, and regulatory affairs, ensuring project timelines and quality standards are met, and promptly addressing any technical or quality issues, providing a single point of contact for streamlined communication.
We offer an array of niche and full-fledged CRO services, from clinical trial protocol development to post-marketing surveillance. Streamline Your Drug Development with Curexbio CRO Expertise
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