DNA Manufacturing Services
Touchlight DNA Services
DNA development and manufacturing to support your advanced therapy production
We offer a range of services including contract development and manufacturing to support development and commercialisation of the next generation of DNA products.
We work with more than 130 biotech and big pharma companies, producing doggybone DNA (dbDNA™) as a critical starting material in mRNA, gene editing, IPSc and viral vector production (AAV & Lentivirus) or as an active pharmaceutical ingredient for use in DNA vaccines and non-viral gene therapy. dbDNA derived AAV has been approved for FIH clinical trials in the US and EMEA. It has also been used in US clinical trials as a starting material for an RNA based cell editing therapy. We are also manufacturing GMP material for phI/II studies.
dbDNA is our novel, synthetic DNA vector and enzymatic manufacturing process, which enables us to produce DNA at unprecedented speed, scale and purity.
What can we do for you?
Discovery
- Catalogue products
- Molecular Biology
- Custom research grade
Pre-clinical
- Toxicology materials
Catalogue products
We have catalogue products available in the following markets for initial evaluation:
- mRNA – luciferase and GFP reporters
- Lentivirus – packaging dbDNA™ and GFP reporter
- AAV – repcap and helper dbDNA™
- Genome editing – HDR template with GFP reporter
- DNA vaccines / non-viral gene therapy – multiple reporters including GFP, luciferase and SeAP with multiple promoters, plus DNA vaccine constructs
Molecular biology
Touchlight can provide construct design services to ensure manufacturability and rapid production of new constructs, as well as optimisation for expression
Custom research grade materials
We can produce custom dbDNA™ at small scale for proprietary sequences.
Custom dbDNA™ material is available in 5-10mg batches at research grade specification (see table below). We perform cloning and/or synthesis of the proprietary sequences as required to produce starting materials for dbDNA™ production.
Custom dbDNA™ is produced via four simple steps:
- Custom sequence is shipped to Touchlight as pDNA (or synthesised if required)
- Custom sequence is cloned into Touchlight pDNA backbone and resulting pDNA template is amplified
- dbDNA™ is manufactured and quality checked
- Custom dbDNA™ is shipped ready for use
Toxicology materials
Our custom dbDNA™ materials for toxicology studies are produced using an identical manufacturing process to that for GMP dbDNA™.
As a result, although dbDNA™ for toxicology studies is produced outside of the GMP environment, it has a comparable specification to GMP (see table below).
Product Grades & Scales
| Discovery Grade | Research Grade | SMart-GMP Grade | GMP Grade | |
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| Scale | 0.5 to 1mg | 5 to 10mg | 100mg to 1g | 100mg to 5g |
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| Product Certification | CoT | CoT | CoA | CoA |
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| Storage of retain sample included |
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| Sequencing |
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| Optional for TSE/BSE Statement |
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| Material QC | Partial | Partial | Full | Full |
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| QA Review | Partial |
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| Manufacture under Quality Technical Agreement |
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| Classified Facility |
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Pre-clinical & Clinical
- GMP dbDNA (critical starting materials)
- GMP dbDNA (drug substance)
Clinical & Commercial
- Commercial supply / on-site supply
GMP dbDNA
We can produce dbDNA™ as a critical starting material for GMP Advanced Therapy Medicinal Product (ATMP) manufacture or as an Active Pharmaceutical Ingredient (API). Both have identical specifications and quality systems.
GMP dbDNA™ can be produced in batches of between 100mg and 100s of grams and is prepared in accordance with EU GMP Part II.
Specifications
| Research Grade | SMart-GMP Grade | GMP Grade | |
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| Product CofA |
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| QC Certified Release |
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| Storage of DNA Starting Materials for repeat orders |
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| Custom Bulk Fill |
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| Custom Formulation |
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| Storage of retain sample included |
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| Sequencing |
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| Animal Derived Component Free |
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| TSE/BSE Statement |
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| Material Management |
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| Vendor Management |
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| Manufacturing Controls |
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| Manufacture under Quality Technical Agreement |
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| Classified Facility |
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Pre-clinical, Clinical & Commercial
- Analytical development
- Scale up development
- Formulation
- Stability
We offer the following development services:
- Analytical development
- Scale up development
- Formulation
- Stability
Pre-clinical, Clinical & Commercial
- Regulatory support
Regulatory support
We offer the following regulatory support services:
- Regulatory strategy for products utilising dbDNA™ either as a starting material or active pharmaceutical ingredient
- Support for health authority interactions, including preparation of documentation for pre-IND or scientific advice meetings
- IND and CTA support for all phases of the product development including IMPD authoring, and responses to regulatory questions
- We can provide access to the DMF for GMP grade dbDNA thereby enabling regulatory acceleration in US
- Change control assessments and regulatory advice
- Preparation of submission documents for IND or CTA amendments and post approval variations
Contact us
Enquire for more information
If you have questions or would like to learn more about Touchlight's DNA Manufacturing Services, please contact us.
Get in touch