Process Development and Optimization

Process Development Services

We provide support during your microbial clinical development through to commercialization. Optimize your existing fermentation and purification processes to improve manufacturability and process economy irrespective of your development stage or expression platform.

Our scientists and engineers have the experience and expertise to help solve challenges such as solubility issues, process yield, product quality and stability. Our microbial development, optimization and manufacturing teams work in close collaboration to ensure seamless transition between project phases. Our analytical and regulatory services are integrated into programs to de-risk your path to the clinic or market.

Fermentation and Recovery Development

Process optimization is key to reducing potential pitfalls, such as formation of product related impurities or improper folding, leading to insoluble aggregates. Our experience with upstream optimization techniques and materials allows us to produce a functional protein across a variety of molecule types. The choice of expression system and product localization will then drive the primary recovery approach. Our recently expanded upstream development laboratory is equipped to develop, optimize and scale a process, improve robustness and cost of goods. Our fermentation expertise includes:

Purification and refold development

Following fermentation, we continue with downstream purification and refolding capabilities. Building on many years of experience, we define a modular workflow to develop the sequence of DSP unit operations. By successfully combining your knowledge of the target molecule, our expertise in biopharmaceutical manufacturing and our standardized high throughput approach, we will give you the best chance to speed up development while maintaining the highest standard of quality. Our downstream purification offering includes:

Process validation support

As your product moves toward commercialization, we begin process validation support activities. These studies increase the process understanding, identify critical process parameters and define operating ranges.

Our team has gained extensive experience over many years with process validation projects. The scope of the studies performed is dependent on your needs and the current regulatory guidelines. As some of the needed information can be collected during a typical program, we recommend an early meeting with the regulatory authority to discuss your regulatory submission strategy, and to jointly develop an appropriate plan. Our validation services include: