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

此博客中的热门博文

What is preclinical testing?

In the process of preclinical testing of a compound or biological agent into a drug, the compound involved must go through the testing phase. First, we need to identify potential targets that can treat the disease. Then, a variety of compounds or preparations are screened out. Any compound that has shown potential as a drug for the treatment of this disease needs to be tested for toxicity before clinical testing to reduce the possibility of injury. preclinical testing What is the basis of preclinical testing? According to US Food and Drug Administration (FDA) regulations, a series of tests are required before a new drug is approved for use. In the first stage, basic research determines a hypothetical target for the treatment of a certain disease, and then screens small molecules or biological compounds to discover any substance with the potential to treat the disease. Then, a preclinical research phase followed, before which, as described above, the potential toxicity of the compou

阅读全文

Inventory of the three major in vitro pharmacokinetic research methods

The metabolic properties of a compound are an essential factor in whether or not it can be used as a drug in the clinical setting, so pharmacokinetic studies of newly synthesized compounds are required in drug development. In vitro incubation with liver microsomes, recombinant CYP450 enzyme lines, and in vitro incubation with hepatocytes are some of the more common in vitro drug metabolism methods. 1. In vitro incubation method with liver microsomes The metabolic stability and metabolic phenotypes of candidate compounds in different species of liver microsomes are good predictors of the metabolic properties of compounds in vivo. They are practical tools for evaluating candidate compounds in the pre-development phase of drug development. Liver microsomes include rat liver microsomes, human liver microsomes, canine liver microsomes, monkey liver microsomes, and mouse liver microsomes. In in vitro incubation of the liver, microsomes are the "gold standard" for in vitro d

阅读全文

Novel Parkinson’s Therapies Possible with New Mouse Model

Parkinson's disease (PD) is a neurodegenerative disorder that is marked by the accumulation of the protein, α-synuclein (αS), into clumps known as Lewy bodies, which diminish neural health. Now, researchers from Brigham and Women's Hospital (BWH) report the development of a mouse model to induce PD-like αS aggregation, leading to resting tremor and abnormal movement control. The mouse responds to L-DOPA, similarly to patients with PD. The team's study (“Abrogating Native α-Synuclein Tetramers in Mice Causes a L-DOPA-Responsive Motor Syndrome Closely Resembling Parkinson’s Disease”) on the use of this transgenic mouse model appears in Neuron . “α-Synuclein (αS) regulates vesicle exocytosis but forms insoluble deposits in PD. Developing disease-modifying therapies requires animal models that reproduce cardinal features of PD. We recently described a previously unrecognized physiological form of αS, α-helical tetramers, and showed that familial PD-causing missense mutati

阅读全文

Shanghai Medicilon Inc.

搜索此博客