IND-enabling Non-cGMP Production and cGMP Manufacturing

Profacgen provide preclinical, clinical and listed drug production services, including non GMP standard production workshops and modular biomedical factories in line with global cGMP standards.

Our production line provides diversified bioreactor scales of 50L, 200L, 500L and 2000L to support the needs of customers in different development stages. At the same time, we can flexibly and quickly adjust our production capacity to meet the requirements of the project. All bioreactors and liquid storage systems use disposable bags, which can significantly reduce the cost of cleaning and maintenance and reduce the risk of cross contamination. At the same time, the conversion of production line can be effectively optimized according to the development schedule of different projects.

We can carry out 50L and 200L scale production in qualified laboratories to support process development and preclinical project research. Our factory can provide cGMP production to support clinical projects and commercial production. During the production process, our production operation and equipment and facilities monitoring are "24/7".

Drug Substance (DS) and Drug Product (DP) production

• From upstream cell culture, downstream protein purification to preparation filling, finished product packaging and other GMP production services.
• Multi-scale (50L-2000L) protein and antibody production line
• Sartorius, GE and Thermo Fisher cell culture production lines can meet different process requirements
• Advanced purification process, automatic chromatography system and ultrafiltration system can ensure high recovery
• Preparation production from filling, lyophilization to packaging
• Disposable production equipment and consumables can reduce the pollution risk of production and shorten the production cycle

Profacgen can provide product testing, release, quality standard setting and life cycle management services in accordance with the application principles of FDA and EMA and ICH guidelines.

• Process test and control: expression, protein concentration, osmotic pressure, bacterial endotoxin, sterility, etc
• Release testing: conduct comprehensive testing for DS and DP release testing, such as identification, purity, impurities, potency, protein strength and safety testing, routine testing, etc
• Stability research: long-term stability, accelerated stability, strong degradation stability detection and in-use stability, etc

With years of project experience in Pharmaceutical Contract Development and Manufacturing Organization (CDMO), we can help you achieve faster time to market. Profacgen looks forward to cooperating with you.