Regulatory requirements for these medicines are continuously evolving. The FDA has published draft guidance on what chemistry, manufacturing, and control (CMC) information should be submitted in an IND, and our team will help you navigate this process.
As with all other therapeutic molecules, there is an expectation for orthogonal analytical techniques to be applied to characterization, stability, and release testing of the final product. In addition to the product testing, testing is also required for assuring the quality of all components of the product including all materials and components used for manufacture of a gene therapy product such as vectors, reagents, and excipients.
We can support your gene therapy development from an early stage, providing method development and validation to meet your milestone and regulatory requirements.
For your gene therapy development, the services we offer include, but are not limited to:
- ICH stability storage and testing
- Method development, qualification, and validation
- General compendial testing
- Viral vector characterization
- Viral vector identity
- Aggregation analysis
- Host cell and residual plasmid DNA
- Methods for liposome characterization-lipid content, release efficiency and encapsulation efficiency.
- Stability Studies
- Subvisible particles, elemental impurities and residual solvents
- Cell-based assays / potency testing (/pharmaceutical/biopharmaceuticals/cell-based-bioassay/) QC release testing (/pharmaceutical/analysis/qc/)
- Advanced delivery technology analytical support (/pharmaceutical/biopharmaceuticals/advanced-therapy-medicinal-product-analytical-services/) Reagent QC analysis and residual reagent determination
- Excipient concentration and QC (/pharmaceutical/analysis/qc/)
- Determination of Residual proteins, DNA, RNA, cytokines, growth factors, serum, antibodies, and solvents