Biologics are recognized as one of the most promising areas for drug discovery and development in the 21st century. In recent years, biologics have been the focus of drug development. As a result, more and more attention has been paid to bioanalysis. Medicilon’s Biotechnology Analysis Service aims at providing bioanalytical service to our domestic and oversea pharmaceutical clients with superior quality, high throughput and efficiency.
Medicilon’s Biotechnology Analysis Service team consists of around 20 experienced scientists and experts. In addition to the facilities we already possessed, we have recently not only configured multiple sets of equipment, but also installed numbers of most-up-to-date equipments such as instrument for immunogenicity analysis in higher standard – MSD Sector S 600. (https://www.mesoscale.com/en/products_and_services/instrumentation/sector_s_600) Labs at Medicilon implement a system for comprehensive information management. For example, we use laboratory information management system (Watson LIMS 7.2) for managing and processing our sample chains, tracking and storing laboratory data, which in turn provides our clients with better services.
Most of the advanced treatments for major diseases are correlated with biological drugs, including oncology immunotherapy, which has recently received widespread attention. Government has placed plenty emphasis on developing biological drugs, such as antibody drugs, gene recombinant protein drugs, and vaccines, due to their outstanding effect on the treatment and prevention of diseases. Since the debut of monoclonal antibody drugs in 1986, more and more pharmaceutical companies carry out the research and development of biologics drugs. Bioanalysis is a pivotal part for early drug discovery, which provides a basic scientific platform for pharmacokinetics, toxicokinetics, pharmacodynamics, immunogenicity and bioequivalence.
The quality of lab work replies heavily on the accuracy and the efficiency of the analytical methods. Medicilon’s Biotechnology Analysis Service Department provides the professional and technical service, which fully complies with FDA / CFDA GLP standards to support the screening and development of protein drugs, antibody drugs, vaccines and biomarkers for their preclinical and clinical studies.
Instruments for Biologics Drugs Analysis
Services for Biological Drugs Bioanalytics
(Mainly Applicable to Antibodies, ADC, Vaccines, Proteins and Others)
Development and Methodological Confirmation of Macromolecule Bioanalysis
Development, transfer, optimization, and validation of immunoassay for the determination of drug concentration in biological matrices
Development and optimization of a variety of monoclonal antibody (Adalimumab, Bevacizumab, Trastuzumab, Pertuzumab and others) and validated immunoassay methods for antibody conjugated drugs
Analysis and Detection for Proteins, Antibodies and Peptides
Pharmacokinetics, Toxiconinetics and Immunogenicity Test
Radioactive Labeling (C14，H3，I125), Tissue Distribution and Pharmacokinetic Study
Metabolic Disease Markers
Cardiovascular Disease Markers
Vaccine Analysis Testing
Monovalent and Multivalent Vaccines
Determination of Titer