Contract Services:

Fermentas has developed a proprietary patent-pending plasmid DNA preparation technology that allows preparation of various grades of plasmid DNA from milligram to multigram quantities suitable for various applications including standard manipulations, transfections and pre-clinical trials in gene therapy and vaccination. The pharmaceutical-grade plasmid DNA is characterized by significantly lower levels of contaminants and endotoxins (10 EU/mg) compared to one obtained using technologies currently available on the market. The pharmaceutical-grade plasmid DNA meets all EU and FDA guidelines for pharmaceuticals and has EU GMP certificate.

1. Research Grade Plasmid DNA:
   For standard DNA manipulations including re-cloning, sequencing and transformation

   • Turnaround time - 15 working days or less

   • Certificate of Analysis included
      

2. Transfection Grade Plasmid DNA:
   For transfection in vitro and in vivo

   • Endotoxin levels below 0.01 EU/µg

   • Free of organic solvents and mutagenic ethidium bromide

   • Free of substances of animal origin

   • Turnaround time - 15 working days or less

   • Certificate of Analysis included
      

3. Pharmaceutical Grade Plasmid DNA:
   For pre-clinical trials in gene therapy/vaccination

   • RNA and genomic DNA content extremely low

   • Host cell proteins content below 10 ng/mg DNA

   • Endotoxin levels below 0.01 EU/µg

   • Free of organic solvents and mutagenic ethidium bromide

   • Free of substances of animal origin

   • Turnaround time - one month

   • Tested according to EU CPMP/BWP/3088/99 and FDA guidelines

   • Certificate of Analysis included 

Introductory Offer (multicopy plasmids)*:

Research grade plasmid DNA
#SD0713, up to 400 mg
#SD0714, up to 1500 mg

Transfection grade plasmid DNA
#SD0722, 2-10 mg
#SD0723, 30 L fermentation (up to 400 mg)
#SD0724, 100 L fermentation (up to 1500 mg)

Pharmaceutical grade plasmid DNA**
#SD0731, 5-10 mg
#SD0732, 30 L fermentation (up to 400 mg)
#SD0733, 100 L fermentation (up to 1500 mg)

* excluding Fermentas 2006/07 catalog items
** tested according to FDA and EU CPMP/BWP/3088/99 guidelines

Additional Post-production Services:

• Restriction enzyme *** digest analysis

• Restriction enzyme digest

• Restriction enzyme digest and DNA fragment purification

• Sequencing

• Plasmid DNA archiving

*** Restriction enzyme digests are performed with Fermentas enzymes all of which meet the PureExtreme® standard of quality.

Please contact contract@fermentas.com to receive a price quote for any of your current or upcoming projects.

Please click here to see a sample Certificate of Analysis, pdf format 126 KB and the sample of Plasmid DNA Specification, pdf format 100 KB.

catalog@fermentas.com

Updated gegužės 10, 2007 11:00