Successful registration of ABSL-2 laboratory! Medicilon becomes a one-stop biopharmaceutical preclinical CRO with both ABSL-2 and BSL-2 laboratories
On October 12, 2023, the ABSL-2 laboratory of Shanghai Medicilon Inc. (Medicilon) obtained the “Registration Certificate for Animal Pathogenic Microorganisms Laboratory in Pudong New Area, Shanghai” issued by the Shanghai Pudong New Area Agriculture and Rural Affairs Committee.
This means that Medicilon has animal experiment facilities with a second level of protection against pathogenic microorganisms, and also marks that the standardization of biosafety management in animal laboratories has been recognized. In addition, Medicilon has become a one-stop biopharmaceutical preclinical R&D service platform with both ABSL-2 and BSL-2 laboratories!
After ABSL-2 laboratory registration and certification, Medicilon can carry out experimental activities on specific Category III pathogenic microorganisms (including virus and pathogenic bacteria-animal infection experiments, operation of uncultured infectious materials, sample testing, operation of inactivated materials, operation of non-infectious materials), such as drug pharmacodynamics evaluation, pathological and toxicological safety evaluation and other one-stop GLP laboratory services.
It is worth mentioning that Medicilon has previously obtained the “Shanghai Pathogen Microbiology Laboratory Registration Certificate (BSL-2)” issued by the Shanghai Pudong New Area Health Commission. Therefore, Medicilon can perform routine cell culture, virus strain infection/virulence determination, in vitro experiments on various pathogenic microorganisms, etc. Collaborating with the ABSL-2 laboratory, Medicilon can provide a variety of experiments such as compound activity screening, tumor cell line culture, tumorigenicity experiments, vaccine efficacy evaluation, antibacterial drug PK/PD, which can provide safe and professional experimental technical services for the research and development of various new drugs (such as AAV gene therapy drugs) to assist and accelerate the drug research and development process. Medicilon’s ABSL-2 and BSL-2 dual qualification laboratories will surely provide strong impetus to accelerate the research and development of new drugs!
After nineteen years of hard work, Medicilon has continuously improved its scientific research layout and advanced into the breadth and depth of new drug research and development technology. In terms of preclinical pharmacodynamics evaluation, Medicilon has established pharmacodynamic evaluation systems for most major human diseases, including many disease model systems from the molecular level to the cellular level, in vitro to in vivo animals. Medicilon have also established over 370 tumor drug efficacy evaluation models and over 230 animal models for the research and evaluation of new non-tumor target new drugs, including evaluation of various types of new drugs from druggability to Class I innovative drug IND submission. After obtaining the ABSL-2 qualification, Medicilon can carry out efficacy modeling experiments on a variety of pathogenic microorganisms and viruses, enabling the development of anti-infective drugs and vaccines.
If you want to do your job well, you must first sharpen your tools. Biosafety laboratories are the main battlefields in the fight against viruses. In the post-epidemic era, Medicilon will continue to follow the service concept of “innovation-driven, quality first” and continue to improve and enhance laboratory technical capabilities, quality management and service levels to ensure the scientific, safe and efficient operation of laboratories and provide global clients with more comprehensive, reliable, high-quality and efficient new drug research and development services.
About ABSL-2 Laboratory
Animal Biosafety Level 2 (ABSL-2) laboratories are suitable for handling pathogenic microorganisms that can cause human or animal diseases, but generally do not pose serious harm to humans, animals or the environment, have limited transmission risks, rarely cause severe disease after laboratory infection, and have effective treatment and preventive measures. The ABSL-2 laboratory has also become the laboratory with the highest usage rate for conducting infectious projects.
About the BSL-2 Laboratory
BSL-2 laboratory is a secondary biological safety protection laboratory, which is a classification of biological laboratory safety level. Among various types of laboratories, BSL-2 laboratories are the most widely used biosafety level laboratories.