Manufacturing

Manufacturing

All dbDNA is manufactured with an enzymatic process.

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

Research Grade
  • Intended for research use only
  • Scales available from 5-20 mg
  • Produced with different purification process compared to Preclinical and Clinical Grades
  • Analytical Report provided with delivery
Preclinical Grade
  • Intended for process development and research use with your capsid and GOI
  • Flexible scale productions available
  • Produced with identical process in same facility as Clinical Grade
  • Full batch record preparation and set specifications
Clinical Grade
  • Intended for toxicology studies and clinical cGMP AAV manufacturing with your capsid and GOI
  • Full batch record preparation and QC/QA release with set specifications
  • Scales available from 100 mg to multiple grams

Projects at Touchlight AAV

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