Quality Control

JOINN is a third-party testing laboratory for drug quality research and verification of protein drugs, vaccines, gene and cell therapy products, etc., providing the society with innovative drug quality standard research, verification method establishment, preparation and identification of standard substances, cell bank, bacteria and virus seed bank, stock solution and finished product testing. Production process quality control key steps such as virus inactivation and clearance verification. According to the requirements of quality evaluation of innovative drug application, new methods, new technologies and new standards were established to meet the constantly emerging demands for quality research and testing of biological drugs, and to support and promote the development and industrialization of innovative drugs.

Drug type:

Monoclonal antibody, bispecific antibody, ADC and other antibody drugs

Vaccines: especially mRNA vaccines, DNA vaccines, etc

Common recombinant proteins: e.g. NGF, insulin, interferon

Complex recombinant proteins: e.g. coagulation factor 8, coagulation factor 9, snake venom

Nucleic acid drugs: RNA, DNA, plasmid

Viral vector drugs: AAV, lentivirus, oncolytic virus, etc

Cell therapy: CAR-T, TCR-T

Others: exosomes

Services:

Release, central control test

Stability study

Biosafety assessment

Methods to transfer

Methods validation

Process development testing

Quality characterization and research

Analytical method development

Testing of raw materials, auxiliary materials and packaging materials

Study and formulate quality standards