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Guangzhou Boji Biomedicine Technopark Co., Ltd. (Boji Technopark) is a platform for CDMO and Incubator. It is located at No. 3, Chuangli Road, Zengcheng National Economic and Technological Development Zone, Guangzhou, with a registered capital of 130 million RMB, a total area of 33,000㎡, and a construction area of more than 36,000 ㎡. There are quality control, office building, oral solid preparation workshop, TCM pre-treatment & extraction workshop, API workshop and supporting facilities such as fire protection, environmental protection and power supply.
The scope of the drug production license includes tablets, hard capsules, granules, powders, pre-treatment and extraction of traditional Chinese medicine, and API.
The dosage forms of the Oral solid preparation workshop include tablets, hard capsules, granules and powders, each of which has two production lines of pilot production and commercial production.The main production equipment includes high shear wet granulator, dry granulator, extrusion spheronizer, spray granulator, fluid-bed dryer, 3-dimension mixer, high-speed tablet press machine, efficient coating machine, fully automatic capsule filling machine, aluminum plastic packaging machine, granule packaging machine, powder packaging machine, automatic bottle packaging line, etc. Production capacity of Each dosage form is around 20-180kg /batch.
Equipped with pre-treatment equipment such as net separator, washing, cutting, drying, pulverization, extraction and purification equipment such as dynamic extraction tanks, single and double effect concentrators, spray drying towers and macroporous resin adsorption column. The traditional Chinese medicine pre-treatment & extraction workshop could meet a variety of process requirements, the production capacity is about 50-300kg / batch.
The API and drug intermediates synthesis workshop and the production line are equipped with multiple sets of 100L--500L reactor, which can meet the reaction conditions of low temperature -30 ° C to high temperature 300° C, and have a production capacity of 5-30kg / batch.The peptide synthesis production line is equipped with a refrigeration centrifuge, a preparation liquid purification system, a freeze dryer, and other equipments. The capacity to produce peptide synthesis products is aroung KG scale.
Equipped with high performance liquid chromatograph, gas chromatograph, atomic absorption spectrophotometer, ultraviolet-visible spectrophotometer, fourier infrared spectrometer, stability experiment box, with a quality management system that meets GMP standards, the quality centre can provide quality assurance for drug pilots and drugs commercial production.
Guangzhou Boji Biomedical Science and Technology Park Co., Ltd. specializes in custom contract pharmaceutical R & D and production business (CDMO) and incubator business. Not only can Boji help customers realize the transfer of new drugs from clinical batch to commercial batch, but they can also provide incubation services for scientists and startups with new drug technology and result.
1. CDMO Services
As a pharmaceutical CDMO enterprise, Boji Science and Technology Park has customized R & D and production capabilities. It can provide customized R & D and production services for pharmaceutical companies, which can significantly reduce production costs, control potential risks, improve operating efficiency, and accelerate product launches. R & D and production services include process development and preparation, process optimization, scale-up production, registration and verification batch production, and commercial production.
(1)Produce customers with APIs for clinical trials and commercial batches;
(2)Provide customers with Chinese medicine extraction, tablets, capsules, granules, powders for clinical trials and commercial production services under GMP conditions;
(3)Packaging and labeling services for clinical trial drugs, in compliance with the requirements for blind management of "GMP for clinical trials";
(4)Provide a service platform for customers to conduct product process research, assist customers to explore process parameters and determine product registration processes, including:
1)Study on process parameters of solid preparation granulation: rapid stirring wet granulation, dry granulation, extrusion spheronization granulation, spraygranulation, coating (Wurster solution);
2)Study on process parameters of Chinese medicine extraction and concentration, study on process parameters of macroporous resin adsorption, study on process parameters of extract spray drying;
3)Study on the suitability of pharmaceutical excipients / packaging materials.
(5)Research on quality control standards, verification of inspection methods, compliance with ICH stability studies;
(6)Serving MAH drug marketing authorization holders settle down.
2. Business Incubator
The existing construction area of the science and technology park is 6,800 square meters, and the plant area is 2,700 square meters. Only the entire floor can be rented. In addition, a planned construction area of 70,000 square meters can be constructed according to the specific needs of users.
The park has convenient transportation, complete supporting facilities and complete planning, fire protection and environmental protection qualifications. With the support of Zengcheng National Economic and Technological Development Zone, the construction of a public service platformand incubator for drug development and production in Boji Science Park has begun to take shape. We plan to service scientists with projects and large-scale health enterprises such as entrepreneurial biomedicine, medical devices, diagnostic reagents, health foods, and functional foods. For the enterprises entering the park, we can not only provide preferential support in registration consultation and rent, but also provide a public service platform for R & D and productionfor the enterprises. Relying on the strong R &D strength of Boji, we can help your products go to market soon. At the same time, when you have needs in funding, you can also make angel investments in your projects through investing funds to ensure that good projects were not delayed because of funding issues.
Guangzhou Boji Biomedical Technology Park Co., Ltd. (CDMO, business incubator)
Address:No. 3 Chuangli Road, Yongning Street, Zengcheng District, Guangzhou
Contact:Mr. Tian (CDMO business)
Contact:Mr. Lin (Incubator business)
Solid Preparation Workshop
It is located in Building No. 10, with a construction area of 5376 ㎡, and a Class D clean area of about 890㎡. The main dosage forms are tablets, capsules, granules and powders. In addition to the function room such as crushing room, weighing room, preparation room, sampling room, total mixing room, granulating room, coating room, tablet room, outsourcing room, the workshop also set up raw and auxiliary materials, finished products, internal and external packing materials, liquid storage, non-conforming product storage, empty capsule storage, and sampling room. The area can produce 800 million tablets, 200 million capsules, and 200 million bags of granules and powders each year.
Whole granule wet mixing granulator
Extrusion Rounding Machine
Automatic high-speed tablet press
The total construction area is 2,560 square meters, of which the clean area of Class D is about 180 square meters. There are mainly functional rooms such as medicinal materials warehouse, medicinal materials selection processing room, extraction and concentration room, spray drying room, cream receiving room, powder receiving room, dry packing room, etc. It is equipped with modern equipment in medicinal material pre-treatment Chinese medicine net selection, washing, cutting and drying, and crushing. There are also extraction and purification equipment such as Chinese medicine dynamic extraction tanks, single and double-effect concentrators, spray drying towers, and resin adsorption columns. Water system, compressed air system, and air purification system can process 500T Chinese medicinal materials every year, conforming to the standards of FDA and EU GMP.
API workshop has a total building area of 2,027 square meters. The first layer produces small molecule drug intermediate sand APIs, the second layer produces peptide synthetic drugs, and the third layer produces antitumor APIs. The annual production capacity of the API workshop is 10T. The workshop can carry out chemical API pilot testing, process verification, commercial production, and MAH commissioned production. The production scale of pharmaceutical intermediates and APIs is 5-30kg / batch.
MainEquipment for General synthetic production line
Main Equipment for Polypeptide Synthesis Production Line
Solid-phase Synthesis Kettle
Preparation of Liquid Phase
Quality Analysis Centre
It is located on the seventh floor of No. 1 office building, including the physical and chemical room, general instrument room, precision instrument room, positive control room, microbial limit testroom, stability experiment room, etc. The construction area of the laboratory is 1,368 square meters, of which class C clean area is about 32 square meters and class B clean area is about 16 square meters. The laboratory is equipped with the most advanced analytical instruments in the world. According to the EUGMP concept, it now has all the physical, chemical, microbiological and product stability analysis capabilities within the scope of drug production licenses.
US FDAcGMP, EUGMP, WHOGMP, China 2010 GMP.
To make conscientious, reassuring, safe, effective & high-quality drug available at reasonable cost in home market.
In 2030, to be one of the domestic first-classmassive health park.
Integrity, Professionalism, Teamwork, Efficiency.