VGXI was awarded the Vaccine Industry Excellence (ViE) Award for Best Contract Manufacturing Organization at the 6th Annual ViE Awards Ceremony held at the World Vaccine Congress on April 17th, 2013 in Washington, D.C.
To read the full Press Release – click here.
The following five categories illustrate what makes VGXI the Best Contract Manufacturing Organization over the rest:
1.The range of services provided in niche and core therapeutic areas
- Production of high quality research grade DNA plasmids for use in pre-clinical trials which can include process development/optimization to meet quality and yield expectations.
- HD, or Highly Documented, DNA plasmids for use as a raw material in viral vector production and toxicology studies. High quality and purity standards.
- Small, medium and full-scale GMP plasmid production for use in phase I/II human clinical trials, that includes a Validated Sterile Liquid Filling Process for 2 and 10mL Vials.
2.Methods of performance improvement or introduction of new services:
- Introduced NTC’s HyperGRO™ Fermentation Technology utilizing the NTC antibiotic resistance-free vectors and performed the largest-scale GMP production achieved to-date.
- Introduced the HD Plasmid Service to provide clients with a feasible alternative to GMP when full GMP production is not required.
- Implemented Single-Use systems in the majority of downstream manufacturing operations.
3.Attention to and quality of relationships with clients:
- VGXI implemented HyperGRO™ Fermentation Technology to achieve a client’s desired result for an antibiotic-free process.
- VGXI provides optimization for difficult projects including non- antibiotic selection, difficult to grow plasmids, large size plasmids, etc.
- Provide service to diverse clientele inside and outside of the US, with the capability to work with different administrative bodies such as the FDA, KFDA, APVMA, etc.
4.Reaching of milestones and final / ongoing outcomes:
- Clients continue to have successful clinical trials using products manufactured by VGXI.
- Meet customer requirements for quality, service, and delivery. VGXI has also qualified, validated and implemented new QC assays to meet client requirements.
- VGXI has been audited by QPs, Clients, and Third Parties; all of which have resulted in approval to manufacture product.
5.Building and maintaining existing and long term partnerships
- Clients return to VGXI to manufacture more product for existing projects and for new projects as they arise.
- Clients have come to VGXI after lack of success using other manufacturers (related to product yield or quality of product and/or service).
- Provided products to clients for Pre-clinical through Phase II studies using VGXI’s patented process and technology.