cGMP Manufacturing

InnoBio is a globally operating Contract Manufacturer for monoclonal antibodies and therapeutic proteins with state-of-the-art cGMP Manufacturing Facility in Putra Nilai, Malaysia. Our multi-product mammalian cell culture facility has been designed in compliance with both EMEA and US FDA guidelines. Through our powerful partnership, the facility was designed by a world's leading cGMP EPCC service provider that has been responsible for numerous cGMP compliant and certified facilities. This extensive GMP know-how and experiences extends to our facility of which design has been successfully reviewed to conform with cGMP guidelines.

The cGMP facility will house Media and Buffer Preparation Room, Cell Culture/Harvest Area, Purification and Aseptic Filling Area and is linked to Quality Assurance, Cell Banking Area and other supporting laboratories. Contained within the Cell Culture/Harvest Area is our multiple bioreactor trains up to 1,000 liters, an associated inoculum suite and primary recovery equipment which includes GE Uniflux and Sartorius Sartoflow Beta Crossflow Systems for efficient cell removal and concentration.

Following initial cell removal and product concentration, purification is performed in pre and post viral purification suites. We are proud to offer highly flexible purification systems to allow a wide variety of chromatographic techniques to be applied.