Process Development

Analytical, Stability and Formulation | Purification & Technology Transfer | Fermentation | Cell Culture

Our process development group has extensive experience designing and assembling processes that are robust, scaleable and suitable for cGMP production of your recombinant protein or peptide product.
Processes are developed using both mammalian and microbial expression systems coupled with state-of-the-art recovery and purification techniques.

We offer a comprehensive range of analytical development services as well as formulation development and stability studies.

Fermentation and Cell Culture

Extensive experience makes Diosynth Biotechnology a world leader in the development of "upstream" processes using both mammalian and insect and microbial expression systems. Several processes developed by Diosynth Biotechnology scientists are now being employed in the production of commercial recombinant protein products in the United States and Europe.

Diosynth has experience with a wide range of expression systems and the development of processes using batch, fed-batch, continuous and perfusion production technologies. We focus on increasing cell densities, cell viability, and maximum protein expression.

Mammalian cell experience includes:

CHO, NS0, BHK
Hybridomas
Murine myelomas
Human cell lines

We are also a world leader in cGMP production using baculovirus expression in insect cell systems (Sf9 and Sf21 cells).

In Fermentation, we have significant experience with E. coli cell lines and we have developed a leading position in the production of proteins from yeast systems such as Pichia.

E. coli Experience

Inclusion bodies
Cytoplasmic
Periplasmic

Pichia pastoris Experience

mut+, muts
Secreted
Intracellular

Flavobacterium Streptococcus

Our scientists will select or develop media formulations (including serum-free and protein-free) and nutrient feed strategies to optimize cell growth and productivity. Once a process is developed at "bench scale" (typically using 10-L fermenters/bioreactors), it will be scaled-up to 110-L scale (mammalian processes) or 140-L scale (microbial processes). Our development infrastructure has been designed to match our clinical and commercial manufacturing facilities. This facilitates rapid and efficient transfer of the developed process to cGMP production.

See also