跳至主要内容

Bioanalytical Laboratory Services of Medicilon

 The Bioanalysis Department of Medicilon provides a comprehensive bioanalytical services compliance with FDA/OECD/CFDA GLP requirement.

With a capacity to analyze more than 250,000 samples per year, Medicilon is uniquely positioned to handle the demands of “fast PK studies” in a wide variety of animal matrices in order to provide streamlined fast feedback using appropriate methods. In the highly competitive environment of drug discovery, turnaround time can make a huge difference in solving important issues in human health. The elucidation of structure activity relationships (SAR) in drug discovery settings requires fast feedback for the understanding of PK/PD properties as determined in appropriate model species.

Medicilon has established over 100 different cancer cell lines for cell-based assays. Respect for and containment of our client’s vital IP is always at the center of our operations.

Medicilon is well positioned to handle even the most demanding screening programs and to function seamlessly with its clients as a “virtual laboratory,” for innovative drug discovery teams.

With broad knowledge of the chemistry of peptides and proteins, an array of modern instruments and a passion for performing science with the highest quality standards, Medicilon’s scientific teams are uniquely prepared to assist clients with the development, validation and use of methods that help bring vital large molecule drugs to market.

Large molecule drugs bioanalysis service capability:

  • Immunoassay Development and Validation of methods for quantitation of drug substances in biological matrices
  • Protein & Peptide & Antibody Drug Analysis
  • Biomarker Screening and Analysis
  • Immunogenicity (ADA)
  • Vaccine

We are particularly pleased when our efforts have inspired our clients to tell us that we have set a new bar, whether it is with our success at turnaround times in first to file settings, or whether it is with our signature approach to analytical methods. The latter has been key to our client’s high rate of success for NDA and ANDA filings.

Medicilon will be pleased to meet with you to discuss how our high standards can be a key factor in your success.

HIGHLIGHTS

  • Small and large molecule quantitative bioanalysis
  • Drug formulation; stability indicated method develoment and validation, potency, purity
  • Biorelevant in vitro drug release studies: design and build in vitro devices, validation for predicting in vivo release

Related Articles:

Bioanalytical Testing Company

标签：

评论

发表评论

此博客中的热门博文

Custom Synthesis

Medicilon has synthesized over 10,000 individual compounds from gram to kilogram quantities, and many compounds are synthesized with more than ten synthetic steps. The overall synthesis success rate is over 95%. High quality products from mg to kg scale Reagents, intermediates, building blocks, and scaffolds Preparation of API or reference standards Development of synthetic routes for impurities and metabolites   On-site analytical support Product delivered with COA Medicilon offers integrated drug discovery services -- Chemistry, Biology & Preclinical Services
发表评论
阅读全文

In Vitro Enzyme Activity Assay

  Kinases play extensive and important roles in signal transduction and co-ordination of complex functions. Currently, about 300 kinase inhibitors have been approved for marketing, among which receptor tyrosine kinase (RTK) inhibitors are the main ones. Medicilon provides high-quality kinase profile screening and has one-stop kinase research services from assay development, high-throughput screening to selectivity analysis. In addition, Medicilon provides many other enzyme activity screens. Wide Variety Provides 200+  in vitro  enzymatic detection methods; 100+ kinases, including CTK, RTK, AGC, CMGC and other kinase families as well as important common mutations Project Flexibility Various types of plates for screening, such as 96 and 384; Multiple flexible kinase profiles, including TK kinase family, CDK kinase family, etc., to meet different customer customization needs. Various Methods Fluorescence detection; Chemiluminescence detection; Absorbance detection LanthaScr...
发表评论
阅读全文

Pharmacokinetics Services

Pharmacokinetics Services Our pharmacokinetics department offers the clients a broad spectrum of high quality of services in the areas of in vitro ADME, in vivo pharmacokinetics and bioanalysis services, ranging from small molecules to large molecules, such as protein and antibody. The animal species involved in our services are non-human primate, canine, mice, rat, rabbit and hamster. Meanwhile, non-human primate experimental platform and isotope platform for protein/antibody are certified by the Shanghai government. Preclinical Pharmacokinetics Method development and validation (GLP,Non-GLP) Bioanalysis Pharmacokinetics (Tumor bearing rodents, Bioavailability, Crossover studies, Cassette (N in 1) dosing and analysis, effects of gender on pharmacokinetics, BBB penetration ) Stability in vehicles and plasma Drug interaction studies In vitro metabolic stability CYP 450 inhibition Plasma protein binding studies Distribution studies Excretion studies Prediction an...
发表评论
阅读全文