Under the guidance of the strategic framework constituted by China Ministry of Science and Technology, the Ministry of Commerce, the Ministry of Health, the State Food and Drug Administration and the Tianjin People's Government to build an international medical innovation park, Morningside Group, in cooperation with Tianjin International Joint Academy of Biotechnology and Medicine (TJAB), Tianjin Science and Technology Commission and the Tianjin Economic-Technological Development Area (TEDA), established Harmonia Biotechnology (Tianjin), Co., Ltd. in June, 2009. Consisting of Drug Analysis and Testing Center and Bio-pharmaceutical GMP Pilot Production Plant, the Company aims to promote the development of Tianjin biomedical industry, and provide high-quality R & D, production, and testing outsourcing services to the global bio-pharmaceutical and food safety sectors.
The Company is located at the intersection of 13th St. and the Dongting Rd of TEDA. The Drug Analysis and Testing Center occupies approximately 2,800 square meters of lab space in the lab building of TJAB, housing state-of-the-art instruments and equipments up to 70 million RMB investment. The Center can carry out analysis, testing and quality assessment studies with biological macromolecules, chemical substances and the complex system of natural medicine.
GMP pilot production platform. integrates bio-pharmaceutical R & D and GMP pilot production. Our services cover fermentation, cell culture, protein purification, formulation research and development, process research and development. Our quality systems and operations are in compliance with the U.S. FDA and EU EMEA standards.
Our mission is to establish a bio-analytical service platform. with sound technology and management in line with international norms and standards by high-quality professional and technical services for the international and domestic high-tech enterprises to create more value, and thus to promote harmonious economic and social development.
We will act in the most serious attitude to each customer's needs, and use our professional service to assist our customers for their successful enterprise development. The processes ensure the results,and staying focused ensures professionalism.
The analytical and testing center can perform. analysis and systematic quality assessment for biomacromolecules, chemical drugs, and complex natural products according to applicable national and international criteria and standards.The capability includes the following:
A．Chemical drug analysis system
Fast screening of synthesized small molecule drug candidates and innovative drugs; In vivo and in vitro metabolite transformation studies and metabolite structure determination for small molecule drugs. Quantitative analysis, purification, and pharmacology, toxicology and formulation studies. Quality standard study and establishment for synthesized raw chemical drugs and their formulation.
Real time fluorescence and luminescence imaging for in vivo functional biology measuring biologically relevant events in animals; cell sorting; cell surface antigen and receptor analyses; purification and analysis of proteins, nucleic acid, and natural products;large scale and fast screening of biomacromolecules; bio-molecule and bio-molecule interaction studies; peptide synthesis, immunoassay, metabolite structure determination, quantitative analysis, purification, pharmacology, toxicology and formulation studies.
C．Analytical service for drugs from natural extracts
The extraction of active ingredient, analysis, and structure elucidation of natural products; purification, characterization and analyses of Chinese medicines and natural herbal drug ingredients; chiral separation; establishment of the quality standard and analytical method for Chinese medicine and its formulation.
D．Food analysis service:
analysis of amino acids, vitamins, and fatty acids in food; analyses of pesticide and veterinary drug residues in food.
The GMP R&D pilot production platform. (under construction) will include microbial production lines, cell culture production line, process R&D laboratories etc, with complete FDA \ EMEA \ SFDA's cGMP standards of production and quality management system. Main functions meet the production requirements for pre-clinical and clinical material needs, in compliance with FDA \ EMEA \ SFDA's cGMP standards. In addition, our GMP platform. can carry out the R & D productions of multiple species simultaneously without mutual interference and cross-contamination.