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

Medicilon and Binhui Biopharmaceutical Have Reached a Strategic Collaboration to Jointly Draw a New Blueprint for the Development of New Biological Drugs

  On March 18, Medicilon and Binhui Biopharmaceutical (Binui Bio) announced a strategic collaboration.  The two parties will work together to jointly explore the possibilities in cutting-edge fields such as oncolytic viruses, nucleic acid drugs and protein drugs. Gather and Work Together to Create Advantages      Facilitate the Research and Development of Oncolytic Viruses, Nucleic Acids, Proteins and Other Drugs As a one-stop biopharmaceutical comprehensive preclinical R&D service CRO, Medicilon has been developing and accumulating for 20 years, always adhering to the spirit of innovation, and has successfully constructed bi/multi-specific antibodies,  ADCs ,  mRNA vaccines ,  small nucleic acid drugs ,  PROTAC , and  CGT technical service platform  that have helped 421 INDs obtain clinical approval.  It is this outstanding achievement that has earned Medicilon wide recognition in the industry and laid a solid foundation f...
发表评论
阅读全文

A Nickel-Catalyzed Reductive Alkylation of Aryl Bromides and Chlorides for Sp3-Sp2 Bond Formation

  In 2012, a nickel-catalyzed reductive alkylation method of aryl bromides and chlorides was reported. Under the optimized conditions, a variety of aryl and vinyl bromides as well as active aryl chloride can be reductively coupled with alkyl bromides in high yields. The protocols were highly functional-group tolerant and the reactions were not air or moisture sensitive. The reaction showed different chemoselectivity than conventional cross-coupling reactions. Substrates bearing both anelectrophilic and nucleophilic carbon resulted in selective coupling at the electrophilic carbon (R-X) and no reaction occurred at the nucleophilic carbon (R-[M]). The 2010 Nobel Prize in Chemistry was awarded for the Pd-catalyzed cross-coupling, and in the past decade the progress in cross-coupling has not only had a significant impact on academic research but has also influenced the industrial synthetic application. The transition-metal-catalyzed union of nucleophilic organo-boronic acids with elect...
发表评论
阅读全文

What is Toxicokinetics?

Toxicokinetics  is essentially the study of “how a substance gets into the body and what happens to it in the body”. Four processes are involved in toxicokinetics. The study of the kinetics (movement) of chemicals was originally conducted with pharmaceuticals and thus the term pharmacokinetics became commonly used. In addition, toxicology studies were initially conducted with drugs. However, the science of toxicology has evolved to include environmental and occupational chemicals as well as drugs. Toxicokinetics is thus the appropriate term for the study of the kinetics of all toxic substances. Frequently the terms  toxicokinetics ,  pharmacokinetics , or disposition may be found in the literature to have the same meaning. Disposition is often used in place of toxicokinetics to describe the time-course of movement of chemicals through the body (that is, how does the body dispose of a xenobiotic?). The disposition of a toxicant along with its’ biological reactivi...
发表评论
阅读全文