Manufacturing Services

VGXI Manufacturing Services

At VGXI, we understand that every plasmid construct is unique. Variables such as plasmid size, stability, the presence of secondary structures, and ITR regions wield substantial influence over plasmid DNA yield and quality. Through initial project discussions and scope planning, the VGXI Process Development (PD) Team effectively addresses these factors to create robust and reproducible manufacturing processes, paving the way for a successful outcome.

Our Process Development initiatives include the following:

Cell Bank Optimization

A high-quality cell bank serves as the foundation for consistent and reliable fermentation results. VGXI’s PD Team can evaluate a variety of cell lines to identify the optimal one for the target plasmid construct and subsequently screen colonies to identify the best clone. Assessment of the selected clone via high-density fermentation and purification provides an accurate gauge of cell bank performance, a crucial step before proceeding to generate the GMP master cell bank and embark on GMP plasmid production.

Fermentation Optimization

For certain plasmids, the PD Team may conduct a series of small-scale (10L) fermentation runs under varying growth conditions to optimize fermentation conditions. The small-scale process involves a comprehensive assessment of factors such as biomass, yield, and plasmid quality, with the goal of optimizing both productivity and quality to enhance downstream applications.

Purification Optimization

To enhance the efficiency of purification, small-scale studies are conducted to optimize conditions based on plasmid size and performance that mirror the full-scale process. Once optimized, the VGXI QC Team executes a series of stringent evaluation assays to ensure the quality and purity of the final product.

GMP Cell Banking & Testing Services

Establishment of a high quality, high-yielding and characterized master cell bank (MCB) is foundational for a successful GMP plasmid manufacturing campaign. At VGXI, all cGMP cell banking activities are performed in a dedicated cGMP cell banking area. GMP MCBs are derived directly from a carefully screened and characterized research cell bank to ensure optimal performance during downstream manufacturing. Clients can choose their preferred bacterial strain for manufacturing, or our expert team can offer recommendations based on established strains that have demonstrated high performance for plasmid DNA production.

Cell Banking and Testing Services

Stability Testing Services

VGXI offers both real-time and accelerated stability testing for pre-clinical, HD, bulk GMP grade plasmids as well as filled drug product studies under varying storage conditions to evaluate the long-term quality and integrity of both bulk drug substances and finished drug products. We can develop customized stability testing studies based on our client’s needs and can accommodate a range of storage temperatures including -80°C, -20°C, 4°C, 25°C, and 37°C.

GMP Aseptic Fill/Finish Services

VGXI provides convenient, in-house GMP aseptic fill/finish services for applications requiring a final formulation and fill into up to 20,000 vials, with validated filling operations for vials from 0.3ml to 10mL. Our procedure involves adjusting the QC-released bulk drug substance to the desired concentration and, if needed, formulating it with non-active or excipient components before the fill/finish process. The formulated drug product undergoes aseptic filtration and is filled in an automated process within an ISO 5 filling enclosure using single-use product contact surfaces to ensure product integrity and purity. Trust VGXI to provide a seamless fill/finish solution tailored precisely to your requirements.

GMP Aseptic Fill-Finish Services

Additional Services

In addition to world-class plasmid DNA manufacturing expertise, VGXI offers a range of additional service capabilities designed to meet diverse project needs:

  • NTC HyperGRO™ Manufacturing Platform (antibiotic-free selection)
  • Process Cost Analysis
  • Assay Development
  • Validation Services
  • cGMP Compliance Audits