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 |
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Clinical sample and |