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IND-enabling Non-cGMP Production and cGMP Manufacturing

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

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.

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.

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