Manufacturing

Manufacturing

All dbDNA™ is manufactured with an enzymatic process.

TAAV manufactures three grades of dbDNA™ in our facility, Research, Preclinical, and Clinical Grade.

R&D GRADE
  • Suggested for evaluation/feasibility studies
  • Scales available from 5-20mg
  • Produced with representative manufacturing process of higher scales
  • Analytical Report provided with delivery
PRECLINICAL (Research) GRADE
  • Intended for process development, research and toxicology studies
  • Scales available starting at 50mg
  • Produced with identical process in the same facility as GMP-compliant grade
  • Full batch record documentation and QA oversight with set of specifications
GMP-COMPLIANT GRADE
  • Intended for toxicology studies, clinical and commercial production
  • Scales available from 100mg to multiple grams
  • Produced under ISO classified production suites following GMP principles
  • Full batch record documentation and QC/QA release with set of specifications

Projects at TAAV

Both standard construct and custom constructs available:

Standard Construct delivery available within 1-2 weeks (10 mg- 100 mg +). Custom Constructs follow the Project Outline.

Project Kick-Off

You have executed a contract to manufacture dbDNA™ with TAAV.

Project requirements and timelines are discussed with your Project Team.

50 ug of your pDNA is shipped to TAAV.

Cloning
(2-6 weeks)

TAAV team confirms cloning strategy with you and initiates cloning into our dbDNA™ precursor backbone to generate the dbDNA™ frame.

Positive clone is confirmed with full sequencing.

pDNA Amplification
(1-3 weeks)

dbDNA™ precursor stocks are sequence verified in both strands.

Small amounts of plasmid DNA are amplified from these stocks to be used as a precursor for dbDNA™ manufacturing.

dbDNA™ Manufacturing
(1 week)

dbDNA™ manufacturing initiated at a scale to guarantee we meet the DNA needs for your project. Scales are available from 75 mg up to 1.5 g.

dbDNA™ will be aliquoted based on specific client needs.

QC Testing
(2-4 weeks)

TAAV performs QC testing in house or with our Qualified Testing Laboratories.

Certificate of Analysis is provided to the client upon completion.

QA Release
(for GMP-compliant)

Batch Release document is provided to the client upon completion.

Shipment

Your TAAV Project Manager will work with you to ensure a smooth shipping process for your released dbDNA™.

Repeated Orders

Timelines for repeat orders of the same construct can be accelerated. We can initiate the same process starting at dbDNA™ manufacturing.

 Facility Image

Facility Information

Located in San Sebastián (Basque Country – Spain).

TAAV offers 14,000 ft2 (1.300 m2) of state-of-the-art facility for the production of dbDNA™ distributed in offices, development, manufacturing and QC areas, and a team of more than 50 professionals. The current manufacturing capacity is 200 grams of dbDNA™ per year but it can be amplified to more than 500 grams in less than 6 months if needed