NTC takes you from Vector Development to In-house Manufacturing
Vector Design, Construction and Production
Fermentation/Process Development
DNA Manufacturing (research grade)
Technology Transfer to CMOs (cGMP)
In-House Manufacturing (cGMP)
|
|
For many years, Nature Technology Corporation has been a leader in high yield plasmid DNA production, providing the optimal process for manufacturing gene-based products such as DNA vaccines and gene therapeutics. Choose from services including: scaled plasmid production (mg to multi-gram); economical shakedown process runs, E. coli cell paste, highly enriched for your plasmid (for you to purify); and tech transfer (to CMO, or to your facility for control of production). These alternatives allow you to transition economically from pre-clinical studies, to cGMP, to full-scale production in a seamless fashion, without having to 're-do' studies due to significant process changes.
|
|
Lessons learned from biomanufacturing NTC:
1) The vector is the initial and success limiting factor, optimize for effectiveness and safety before proceeding;
2) Combining the optimized of vector, host cells, and process will lead to success in manufacturing
3)Quality and regulatory continuity are provided through technology transfer to cGMP contract manufacturing facilities and to your final manufacturing destination.
|
|
One advantage of the HyperGRO process is the highly-enriched, plasmid-containing cell paste, which serves as the starting point for downstream purification. For example, a culture producing 1,000mg/L or 2,500mg/L requires the processing of only 1/10th or 1/25th as much biomass, respectively, as a culture producing 100mg/L. Thus, the resulting DNA is more pure, the process is less wasteful, and the cost of manufacturing is reduced.
NTC's E. coli fermentation process is the most efficient one available today, producing as much as, or greater than 1-2.6 g/L in fed-batch fermentation. This allows NTC to provide you with the most economical pricing, while providing highest quality products.
Process development at NTC uses our patent pending fermentation process and Proprietory HyperGRO™ media formulations (left).
|
|
|
