Tianjushi Group has many qualifications such as Class A design in chemical, petrochemical and pharmaceutical industry, Class A design in construction industry, Class A general contract for mechanical and electrical installation engineering construction, and Class A general contract for construction engineering construction. Adhering to the concept of "quality comes from design", Tianjushi Group is deeply focusing on areas such as biopharmaceuticals, medical devices and laboratories. The business unit is dedicated to providing biopharmaceutical companies with one-stop general contracting solutions including professional consulting, designing, purchasing, construction and GMP regulation services.
The design team not only has many years of work experience in major domestic medical design institutes, but also has many years of experience in internationally renowned engineering companies, and has cooperated with engineering companies in the United States, Europe, and Australia.
The core members of the team have more than 20 years of experience in the medical design industry, including technical consulting, engineering, design, project management and other fields. The team has design experience in international engineering projects and has participated in many large-scale pharmaceutical projects.
Provide professional one stop service from consulting, design, procurement, construction to GMP consulting
Insight into customer needs, understanding of production processes, starting from GMP compliance, focusing on energy conservation, environmental protection and intelligent manufacturing, meeting customer needs from the initial design stage of the project to the implementation process of the project, and focusing on the guarantee of customer's plan, investment and progress
The Biopharmaceutical Business Unit of Tianjushi provides delivery documents in accordance with international standards and national regulations
In the conceptual design and basic design phases, documents such as mass balance & PFD, staff scheduling, public engineering consumption table, room list, bill of quantity and validation compliance
In the detailing phase, 3D modelling will be designed with BIM, providing drawings meeting construction requirements
FDA Review Meetings
URS and Risk Assessment
Validation Master Plans
Protocol Generation and Execution
Cleaning/Sanitization,and Sterilisation Validation
With a global engineering perspective, it has participated in and led the construction of nearly 100 pharmaceutical factory facilities that meet the requirements of China's new version of GMP, FDA and EMA. It has already had industry representative cases in macromolecular biological drugs and high-activity products, especially in the fields of new biological agents such as monoclonal antibodies, vaccines, insulin, cell therapy and gene therapy.The implementation of the project adopts the international project management mode to provide the owner with advanced project management.
Product Type: Adenovirus vector vaccine (COVID-19 vaccine)
Project introduction: New production line of raw liquid and preparation, supporting public works, quality inspection and testing, animal room, warehouse, supporting outer pipe and fire control system renovation.Gross floor area: approximately 51,446m².
Product Type: monoclonal antibody
Junshibio is an innovation-driven biopharmaceutical company dedicated to the discovery and development of innovative drugs, as well as clinical development and commercialization worldwide.The pilot plant is located in the production workshop of Junshi Industrialization Base, covering an area of about 3200m².
Product type: Gene therapy
Project Description: Heyuan Biology is a leading domestic high-tech enterprise integrating basic research of life science, incubation of gene therapy drugs and industrial preparation of clinical-grade recombinant viruses.The construction project of Heyuan Zhizao Precision Medical Industry Base covers an area of 50 mu, with a building area of about 80,000 square meters.Including quality inspection workshop, a number of production workshops, warehouses and public works and other auxiliary facilities, the construction can provide lentivirus, adeno-associated virus, plasmid and a variety of oncolytic viruses and other gene carrier GMP production workshop, can better meet the domestic and foreign gene therapy drugs and CAR-T cell therapy drug development market demand.
Products: mRNA vaccine
Project description: including clean decoration engineering, general decoration engineering, non-clean public works, fire engineering, HVAC system engineering, plant necessary stainless steel sanitary ware, electrical and automatic control system engineering, environmental protection engineering, etc.
Product type :PLA raw material Engineering Project Description: Located in Hexiang Science and Technology Center, Qiantang New District, Hangzhou, including r&d laboratory and GMP production plant, with a construction area of 7500 square meters
Project overview: The total area of the planned project is 21970.68 square meters, including four fermentation and purification workshops, one power workshop, one warehouse and other auxiliary production and living facilities.
Product solutions: collagen disc freezing line, aseptic presealing line, aseptic vial freezing line, aseptic eye drops filling line, aseptic vial filling line, gel production line, mask production line, hose production line, cream production line, etc.
Project standard: GMP
Product type: Monoclonal antibody & ADC drugs
Project Description: The project covers an area of 80 mu, with a floor area of 102,091 square meters, including 5 production workshops, 2 workshops for mammalian cell (CHO) antibody expression stock solution, 1 ADC drug production workshop, 1 EScherichia coli expression stock solution workshop, and 1 preparation workshop.
Project introduction: Cell gene therapy research and development and commercial production base
Products: Cell gene therapy drugs
Project description :CAR T Cell Preparation Center (GMP Pharmaceutical Factory)
Project product: cell therapy
Product Type: new type vaccine
Project Description: New vaccine manufacturing plant of R-PHARM Pharmaceutical Group in Moscow, Russia