Tarlead Biology
Antibody drug process development and
production service platform (CDMO)
4 years of operational experience, 5 IND projects in China/the United States/Australia, rich experience in dual antibody projects
Focusing on providing customers with a full range of one-stop CDMO services for macromolecular biopharmaceuticals, it is located in Suzhou Industrial Park, with a building area of 8000 square meters, covering process development, raw solution production and preparation filling.
Business scope
Factory facilities
Plant facility area:
8000 square meters
The functional differentiation is:
Production area:
Raw liquid workshop, formulation workshop, public system, warehouse, and QC laboratory
R&D area:
Screening of cell lines, development of upstream and downstream and formulation processes, development of analytical methods, and pilot workshops
Office area:
Training room, archive room, conference room, and office
Quality system

Tai Li Bio has established a drug production quality management system that meets regulatory requirements such as FDA, EU, NMPA, WHO, etc. The quality system is continuously updated through quality management reviews and continuous improvement procedures. Quality risk management and knowledge management are integrated throughout the entire process of establishing and operating the quality system. Currently, it has successfully supported the application of five IND projects in China, the United States, and Australia.

The specific quality management system is divided into six major systems, classified as follows:
  • 01
    Quality system
  • 02
    Matrials System
  • 03
    Production System
  • 04
    Packaging and Labeling
  • 05
    laboratory system
  • 06
    Equipment and Facilities
Production capacity
We have a workshop that meets cGMP standards, with a clean area of approximately 1600 square meters, including three workshops for cell culture, purification, and formulation.
Cell culture workshop: Multi scale (200L * 1500L * 1, 1000L * 2) disposable reaction tanks, with an annual production capacity of about 40 batches.
Purification workshop: Equipped with imported chromatography system, chromatography column, virus removal and ultrafiltration equipment, it can achieve purification requirements of different scales (200L-1000L).
Preparation workshop: 1 fully automatic washing, drying, filling and rolling linkage line, which can meet the production of various specifications (2ml-20ml) of water needle products, achieve 100% online weighing, and have an annual production capacity of 400000 bottles.
The team members are mostly from well-known domestic biopharmaceutical companies, with rich experience in technology transfer and GMP production and management. Three of the biopharmaceutical projects they have been responsible for have already been launched.
Company dynamics