DNA Sequencing for Regulatory Submission
Good Laboratory Practices and Current Good Manufacturing Practices
Beckman Coulter Genomics has been a leader in regulatory submission DNA sequencing services since 1990. Although many of our customers’ needs have changed since we began, their need for consistent, high quality results has not. We operate facilities that generate the highest quality data in support of clinical trials and clinical diagnostics. Beckman Coulter Genomics’ facilities use a quality program that incorporates components of Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) regulations as they apply to the services offered.
The Advantages of Using Beckman Coulter Genomics for Regulated DNA Sequencing Projects:
- Proven experience in supporting 510(k) submissions where a sequencing reference method is needed
- Full adherence to relevant regulations and guidelines, designed to support both preclinical and clinical needs
- Dedicated study director is the primary point of contact to ensure project goals are met
- Performed greater than 2000 projects in supporting IND submissions and BLA filings for cell line characterization for bulk and final product testing
All regulated DNA sequencing projects include a detailed study protocol approved by the QA Unit; four fold coverage of every base; following of quality assurance approved SOPs and other controlled documents; review of project documentation by a second scientist to ensure scientific integrity of the study and a final quality inspection by the QA Unit and inclusion of a QA statement.
Applications for Regulated DNA Sequencing Projects
- Genetic stability testing of cell banks producing recombinant proteins or monoclonal antibodies
- Validation of your assay for pharmacogenetic and genetic tests
- Independent DNA sequence verification of In Vitro Diagnostic test results
- Complete vector and transgene sequencing of Gene Therapy products
- Vaccine lot sequencing
- Release testing of viral products, DNA or RNA
Regulatory services are designed to support both preclinical and clinical needs, with full adherence to relevant regulations and guidelines including CFR Title 21 Part 58 for GLP, CFR Title 21 Part 210 and 211 for GMP, and CFR Title 21 Part 50 and ICH E6 for GCP.
