Downstream

Downstream Process

Bionova Scientific™ works closely with you to rapidly develop robust downstream processes. Our proven BNS downstream process development platform ensures maximized yields and minimized impurity content. Bionova also optimize your existing process through a tailored program to achieve your particular project goals (titer and product quality related enhancement).

Bionova Scientific has extensive MSAT experience in scale-up facility fit, ensuring successful and effective cGMP manufacturing.

Other services include:

Filter sizing and flux studies

In-process hold studies

Process verification at scale, using AKTA Ready and AKTA Pilot

Viral clearance studies

Process Characterization

Other custom solutions

Our process development services are flexible, reliable, rapid, and transferable. We provide high quality processes for your products on budget and on time.

Formulation

With our team of experienced protein chemists, Bionova Scientific™ offers flexible, reliable, and rapid development for your formulation needs. Whether the product is a new biologic entity or a biosimilar, product quality and safety is our primary focus.

We offer comprehensive study design aiming for rapid and reliable formulation selection:

Factorial design of experiment for rapid effect screening under accelerated temperature conditions

Surface response design for critical factor level determination

Storage temperature product stability correlation study for product shelf life prediction

Real time long-term formulation stability

Extensive characterization of the product and degradation profile

Other custom solutions

Regardless of your product development stage, we will deliver results to suit your need.