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

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Medicilon’s Bioanalytical Services