NATX Plasmids, for: DNA Vaccines, Gene Therapeutics, Viral Vectors andBiophamacueticals

Process Development
From Vector Development to in-House Manufacturing

NTC Contacts:
Phone: (402) 323-6289 (natx)
Fax: (402) 323-6292
Email: support@natx.com

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NTC PRODUCTS AND SERVICES

MAMMALIAN EXPRESSION VECTORS
X• Antibiotic-Free Vectors
X• Rig-I Activating Vectors
X• Linear Vectors
X• Recombineering Vectors
X• Gene Silencing (transient)
X• Gene Silencing (retroviral, stable)
X• Anti-Silencing Elements
X• Vector Pricing

CELL LINES
X• Autolytic E. coli Cell Lines
X• dcm- Strains

VACCINES & ADJUVANTS
X• DNA Vaccines
X• Rig-I Activating DNA Vaccines
X• Thermostable Protein Expression

PRECISION CLONING
X• Services and Pricing

RECOMBINANT PROTEINS
X• pVEX™-E. coli Expression Vectors
X• Fluorescent Proteins
X• Products, Vectors, Services, Prices
X• CofA (SAMPLE)

PLASMIDS
X• Small Scale Plasmid DNA
X• Small Scale C of A
X• Large Scale Plasmid DNA
X• Large Scale C of A
X• Plasmid DNA Order Form
X• E. coli Cell paste
X• NEW! Plasmid Detox Service
X• Additional Testing

PROCESS DEVELOPMENT

DNA FERMENTATION PROCESS
X• HyperGRO™ Publications
X• E. coli Cell Paste

HYPERTAQ™ DNA POLYMERASE

CONTRACT QC
X• E. coli Genomic DNA Testing
X• Residual RNA qPCR
X• Residual RNA gel
X• Supercoil Assay
X• Lymulus Endotoxin Testing

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 at NTC:

1) The vector is the initial and success limiting factor, optimize for effectiveness and safety before proceeding;

2) Combining optimization 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.



Licensing Opportunity:

Fermentation process for industrial production of plasmid DNA (pDNA).

NTC’s leading DNA fermentation process technology is available for production of DNA vaccines, gene medicines, and plasmids for viral vector production. A standard, non-exclusive technology transfer gives access to the process, know-how and media needed to obtain much higher yields of DNA ( 2.6g DNA/liter).

NTC Contact:
Dr. Clague Hodgson, CEO
(402) 323-6289 (natx)


XXRelated Articles


Escherichia coli fermentation for increased plasmid DNA production. Biotechnol. Appl. Biochem. 45:155-166. Carnes, A.A., Hodgson, C.P., Williams, J.A. (2006) Inducible


Rapid process development for high yield plasmid DNA fed batch fermentation. Biopharm. Intl. 22(11): 46-52. Williams, J.A., Hodgson, C.P., Carnes, A.E. (2009)


Generic plasmid DNA production platform incorporating low metabolic burden seed stock and fed-batch fermentation processes. Biotechnol. Bioeng. 103:1129-1143. Williams, J.A., Luke, J., Langtry, S., Anderson, S., Hodgson, C.P., Carnes, A.E. (2009)


Plasmid DNA production combining antibiotic-free selection, inducible high yield fermentation, and novel autolytic purification. Biotechnol. Bioeng. 104:505-515. Carnes, A.E., Hodgson, C.P., Luke, J., Vincent, J., and Williams, J.A. (2009).


Plasmid DNA Fermentation Strain and Process-Specific Effects on Vector Yield, Quality and Transgene Expression.  Biotechnol .Bioen.g 2011; 108: 354-363. Carnes, A.E., Luke, J.M., Vincent, J.M., Schukar, A., Anderson, S., Hodgson, C.P., Williams, J.A. (2010)


Critical design criteria for minimal antibiotic-free plasmid vectors necessary to combine robust RNA Pol II and Pol III-mediated eukaryotic expression with high bacterial production yields, J. Gene Medicine 12(10):818-31. Carnes, A.E., Luke, J.M., Vincent, J.M., Anderson, S., Schukar, A, Hodgson, C.P., and Williams, J.A. (2010)