red horizontal rule
 

Our 60L cGMP "Uni-Suite" is available for smaller scale projects where both fermentation and purification are performed in the same space for secreted and intracellular products.

The space is designed for ISO 8, but under dynamic conditions is able to maintain ISO 7.

The UNL BPDF has an established environmental monitoring program, change control program and performs all purification steps after harvesting in closed systems. The suite has a Class 100 hood for any open-operation of the product. This suite has been used to produce injectable sterile Phase I clinical material.

 

packed column in 3rd floor facility