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Bioanalytical Testing Company

Medicilon is the leading Preclinical Contract Research Organization (CRO), providing bioanalytical cro services to the global biopharmaceutical markets.

Our protein analytical services could identify a protein by molecular weight, sequence confirm the primary structure of a protein and detect post translational modifications, characterize a protein by aggregation, thermostability, size, charge, and pI, measure a protein's purity/impurity, determine the amino acid sequences of a purified protein sample or discover the amino acid sequence of an antibody, compare one protein or antibody sample to a second sample or biosimilar molecule, and more.

bioanalytical cro bioanalytical testing

Bioanalytical Services for Preclinical Studies:

  • Bioanalytical Method Development and Validation
  • Dose Formulation Analysis
  • Bioanalysis of Preclinical and Clinical Samples
  • Test Articles: Small Molecules and Large Molecules, including Protein, DNA, RNA, Vaccines
  • Biomarker Analysis

Small Molecule Bioanalytical Services:

  • International Clinical Trials
  • BA/BE Studies
  • GLP-Compliant Preclinical Research
  • Early DMPK Screening
  • Reference Standards and Stable Isotope Labeled Internal Standards Synthesis

Large Molecule Bioanalytical Services:
Medicilon offers comprehensive and FDA/CFDA GLP-compliant bioanalysis services to support preclinical and clinical development for small molecule drugs, biologics, vaccines and biomarkers.

We leverage the experience of our leaders, managers and scientists to effectively meet clients’ requirements of accurate, timely, high-quality results with:

  • Efficient, timely support of complex analytical challenges
  • Advice on procedures/methods to obtain the needed data
  • Refined analytical standard operating procedures (SOPs) and lab procedures

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The Launch Meeting was Held by Medicilon and DAC Biotech of the Contract Research on ADC Preclinical Study

  Chuansha, Shanghai, Nov. 8th, 2019 — Medicilon held the launch meeting with Hangzhou DAC Biotech Co., Ltd to initiate the   preclinical study   of the antibody-drug-conjugate (ADC)  DXC005, including the   pharmacology study ,   DMPK study   and the   safety evaluation . Medicilon has previously completed integrated  preclinical research  on ADC drugs cooperating with DAC Biotech and other companies. Two of them has been approved by NMPA and entered Phase I clinical trials. About Hangzhou DAC Biotech Co., Ltd Hangzhou DAC Biotech, Co., Ltd was officially registered in HEDA Area, Hangzhou City, Zhejiang Province, China around the end of Year 2012, and is located nearby the bank of beautiful Qiantang River. The company focuses on developing conjugate of monoclonal antibody and small molecular cytotoxic drug, both of which are banded together with smart linkers. About Antibody-Drug-Conjugate (ADC) ADCs ...

Medicilon assisted Hangzhou DAC Biotech in approval of clinical study of ADC drug DAC-002

  On July 20, 2020, DAC Biotech’s new   ADC drug development , TROP2-ADC—DAC-002 was approved of clinical study by NMPA. for the indication of solid malignant tumor. Medicilon completed   preclinical pharmacokinetic  and toxicological studies in this project, accelerating the development process. DAC-002 is an ADC anti-Trop2 monoclonal antibody conjugated by an intelligent ligand against Tubulysin B analogue. It is used to treat Trop2 triple negative breast cancer, small cell lung cancer, non-small cell lung cancer and pancreatic cancer.Trop2 can promote the proliferation, invasion, metastasis and diffusion of tumor cells, and its high expression is closely related to the shortening of survival time and poor prognosis of tumor patients. Therefore, it is of great significance to study anti-tumor drugs targeted by Trop2. Reference: Medicilon Assists - The first China-made targeting folic acid receptor FRα ADC injection BAT8006 was approved for clinical use Medicilon As...

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...