Critical to ensuring successful and economical production is having a stable and repeatable process. The goals of process development (PD) include:
– Maximizing the production capacity of a therapeutic platform
– Creating a sustainable, reproducible and transferable manufacturing system
– Reducing manufacturing costs
– Extending intellectual property protection or proprietary know-how through innovation
– Satisfying the regulatory requirements necessary for FDA approval
The development and optimization of biologics manufacturing processes is a difficult and complex task. For small firms, acquiring PD capabilities is expensive and often off focus, and expensive. Contracting your PD needs to Omnia allows you to focus on your discovery and scientific research while we take on the industrial development.
Omnia’s PD team works hard to ensure you have a process that meets FDA regulatory requirements, reduces your costs going forward and maintaining high quality standards.