Nanotherapeutics Process Development Group can develop an entire process or optimize individual steps in an existing process to ensure the process is suitable for manufacturing in a cGMP environment. Our Process Development group can screen production strains to select a cell line that will efficiently provide the best possible expression of your drug substance. We develop processes to take advantage of methods, such as high cell density fermentation, to increase product yield and manufacture the best quality product in the most efficient way possible. In creating a manufacturing process suitable for cGMP production, our process scientists take a modular, Design Of Experiment (DOE) based approach to develop optimal fermentation and product recovery processes, as well as downstream purification steps. The Process Development group works hand-in-hand with our Analytical Group to ensure the integrity of your molecule each step of the way. Technology transfer of an existing process from the Process Development Group to the cGMP Manufacturing Group will support an integrated approach of the manufacturing process into the cGMP manufacturing facility.
Cell Line Development
We offer mammalian cell line development capabilities and can work with most commercial recombinant mammalian cell lines to assist partners with final cell line selection, comparability assessments and cell line characterization.
- Generate MCB and MWCBs
- Cell line selection
- Cell line quality assessment
- Cell line characterization
- Cell line stability
- Alternate storage methods
Upstream Process Development
Nanotherapeutics Manufacturing team has significant experience with cell culture bioreactor processes up to 1,000L in SS and SUS systems.
- Batch, fed-batch, or perfusion process development
- Media evaluation/comparison
- Seed train/inoculum development
- Media optimization
- Critical parameter definition
- Qualification support
Purification Process Development
Nanotherapeutics Manufacturing team also has significant experience with both ‘platform-type’ antibodies and more complex non-antibody recombinant protein purification processes. This gives us the capability to design, develop, optimize and troubleshoot downstream processes with a variety of approaches.
- Protein purification
- Chromatography development
- Filtration step development
- Process transfer/optimization
- Viral clearance