CUSTOM MANUFACTURING
Tailored DNA production to support your advanced therapy and vaccine needs
Looking for expert support with your custom DNA manufacturing project?
How custom manufacturing DNA works
From initial design to GMP production, Touchlight’s tailored approach ensures optimal construct development, scalability, and regulatory compliance.
Product Grades & Scales
Discovery Grade | R&D Grade | SMart-GMP Grade | GMP Grade | |
---|---|---|---|---|
Product Segragation | ||||
Product Specification | ||||
Product Certification | CoT | CoT | CoA | CoA |
Formulation Options | ||||
Storage of Retain Sample Included | ||||
Sequencing | ||||
Optional for TSE/BSE Statement | ||||
Material QC | Partial | Partial | Full | Full |
Approved Vendors | ||||
Manufacturing Controls | ||||
Document Control | ||||
QA Review | Partial | |||
Manufacture Under Quality Technical Agreement | ||||
Batch Pack | ||||
Classified Facility |
Specifications
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, z-dbDNA are prepared in accordance with EU GMP Part II
Research Grade | SMart-GMP Grade | GMP Grade | |
---|---|---|---|
Product Specification | |||
Product CoA | |||
QC Certified Release | |||
Storage of DNA Starting Materials for Repeat Orders | |||
Custom Bulk Fill | |||
Custom Formulation | |||
Storage of Retain Sample Included | |||
Sequencing | |||
Animal Derived Component Free | |||
TSE/BSE Statement | |||
Material Management | |||
Vendor Management | |||
Manufacturing Controls | |||
Document Control | |||
QA Review | |||
Manufacture Under Quality Technical Agreement | |||
Batch Pack | |||
Classified Facility |
Explore our services
From off-the-shelf catalogue products to bespoke GMP manufacturing, we provide you with scalable solutions that support gene therapy, vaccines, and vector production and development.