Services

We offer a range of services including contract development and manufacturing to support development and commercialisation of the next generation of DNA products.

We already work routinely with more than 50 biotech and big pharma companies, for example producing dbDNA™ as a critical starting material or active pharmaceutical ingredient for use in mRNA vaccines and cell and gene therapies.

What can we do for you?

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 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:

  1. Custom sequence is shipped to Touchlight as pDNA (or synthesised if required)
  2. Custom sequence is cloned into Touchlight pDNA backbone and resulting pDNA template is amplified
  3. dbDNA™ is manufactured and quality checked
  4. 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).

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Specifications

Research Grade Pre-Clinical Grade GMP Grade
Product Specification
Product CofA
Storage of DNA Starting Materials for repeat orders
Custom Bulk Fill
Custom Formulation
Storage of retain sample included
Sequencing
Certified animal-free production process
TSE/BSE Statement
Material Management
Vendor Management
Manufacturing Controls
Document Control
QA Review
Manufacture under Quality Technical Agreement
Batch Pack
Classified Facility

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.

Get in touch

Please enquire for further information.

Contact us

Specifications

Research Grade Pre-Clinical Grade GMP Grade
Product Specification
Product CofA
QC Certified Release
Storage of DNA Starting Materials for repeat orders
Custom Bulk Fill
Custom Formulation
Storage of retain sample included
Sequencing
Certified animal-free production process
TSE/BSE Statement
Material Management
Vendor Management
Manufacturing Controls
Document Control
QA Review
Manufacture under Quality Technical Agreement
Batch Pack
Classified Facility

We offer the following development services:

  • Analytical development
  • Scale up development
  • Formulation
  • Stability
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Please enquire for further information.

Contact us

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, DMF preparation and responses to regulatory questions
  • Change control assessments and regulatory advice
  • Preparation of submission documents for IND or CTA amendments and post approval variations
Get in touch

Please enquire for further information.

Contact us
Contact us

Enquire for more information

If you have questions or would like to employ our services, please contact us.

Get in touch