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Strive to enable biopharmaceuticals created and
manufactured by China to benefit patients worldwide

Contract Development and Manufacturing Organization (CDMO) for antibody drugs

The platform has the China’s largest mammalian cell culture production line conforming to EU construction and quality control standards and with the highest degree of scientific density, and the total working capacity is 38,000 L. In addition, it is equipped with the professional R&D laboratory and sophisticated equipment for antibody drug development, analysis, testing and formulation development as well as years of deep experience and smart resources accumulated through the technological development and commercialization of two domestically successful industrialized antibody drug products (Etanercept and Jiannipai), which can provide customers with integrated professional technical services, ranging from front-end process development of antibody drugs to commercialized product production and registration approval support.

List of key information for each production line of the platform

Production line facilities Process Single line scale Total scale Qualification
300L medium experimental line Fed-batch 220L 2* 220L /
Production line A Fed-batch 500L 3* 500L GMP (2005)
Production line B Fed-batch 3000L 2*3000L GMP (2010)
Production line C Fed-batch 5000L 3*5000L /
Production line D Fed-batch 5000L 3*5000L /
Preparation filling line Dosage form Strength Capacity Qualification
Preparation Area Ⅰ Liquid/freeze-dried 2ml~20ml 120 pieces (2ml penicillin bottle)/min GMP (2005)
Preparation Area II Pre-filled needle 1ml 4500 pieces/h /
Preparation Area III Liquid/freeze-dried 2ml~50ml 300 pieces (2ml penicillin bottle)/min) GMP (2016)

Service content

Company services cover the following professional value chains:

Service advantages

Maximize the resource advantages of Sunshine Guojian’s world-class hardware and senior professional experience in the field of antibody drug development and preparation production. The platform provides customers with comprehensive balanced high value-added professional technical services - Quality Excellence - Integrity Compliance - Time Efficiency - Cost Economy;


Strictly abide by business integrity and professional compliance, and protect the intellectual property rights and related rights of customer projects; implement professional project management to ensure the efficient promotion and implementation of customer projects. By assisting customers to succeed, it can better meet the potential unmet needs of the Chinese and global pharmaceutical markets, allowing patients to benefit from more effective drugs with controllable costs and ensured quality and safety.

The new drug R&D services that the platform can provide (multiple choices, “√”)

Drug screening Process route planning Quality research Pharmacology and pharmacodynamics research Pharmacokinetics research Safety evaluation Clinical study Pilot scale-up Registration application Others
         

Clinical sample and
commercialized production

Contact information:CMO@3Sbio.com