The VGXI team has several decades of combined experience in the production and characterization of DNA pharmaceuticals. In addition to the core manufacturing services, our team can support all aspects of our client’s project needs by providing a variety of additional process and quality related services.
Process Development
Every plasmid is different and varying parameters such as plasmid size, stability, presence of secondary structures, ITR regions, etc. can affect yield and quality. It is critical for these factors to be considered during initial project discussions and planning of the project scope.
Process Development projects may include the following:
Cell Bank Optimization
The process development lab can assess a variety of cell lines and screen a number of colonies to generate a high quality cell bank. Evaluation of the selected colony by high density fermentation and purification allows the most accurate determination of cell bank performance prior to generation of the GMP master cell bank and GMP plasmid production.
Fermentation Optimization
For some plasmids, a series of small scale (10L) fermentation runs may be conducted under various growth conditions. Biomass, yield, and plasmid quality are assessed to maximize productivity and quality for downstream applications.
Purification Optimization
Small-scale purification studies are performed using methods representative of the full-scale purification process. Conditions are optimized based on plasmid size and performance at each purification step. Quality Control performs a series of stringent evaluation assays on the final product which, once approved, is delivered to the customer along with a detailed certificate of analysis.
GMP Cell Banking
Creation of a high quality, high-yielding master cell bank (MCB) provides a solid foundation for a successful GMP plasmid manufacturing campaign. At VGXI, the MCB is generated directly from a carefully screened and characterized research cell bank to ensure optimal performance in downstream manufacturing. All of VGXI’s cGMP cell banking activities are performed in a dedicated cGMP cell banking area. Manufacturing can utilize a client’s preferred bacterial strain, or a recommendation can be provided based on standard strains that have demonstrated high performance for plasmid DNA production.
GMP Fill/Finish
For applications requiring a final formulation and fill into vials, VGXI can provide convenient, in-house GMP fill/finish services. The QC released bulk drug substance is adjusted to the specified concentration and if applicable, formulated to contain any non-active or excipient components. The formulated drug product pool is then aseptically filtered and filled via an automated process within an ISO 5 filling enclosure.
VGXI GMP fill/finish capabilities:
- Validated filling operation for 2 to 10mL vials
- Single-use product contact surfaces
- Experience in supporting high concentration plasmid products up to 15 mg/mL
- Experience in producing and characterizing multi-plasmid formulations
Supporting Services
A range of additional services are available including:
- Real-time and accelerated stability testing for bulk and filled products
- Process cost analysis
- Assay development
- Cell bank characterization
- Complete release testing for all plasmid products
- CMC support
- Validation services
- cGMP compliance audits and consulting
