Future Proof Your Advanced Therapies Supply Chain with VGXI’s US-Based Plasmid CDMO Expertise
In the current landscape of biopharmaceutical drug development, finding a reliable and experienced contract development and manufacturing organization (CDMO) partner is a strategic advantage that can greatly influence the success of an advanced therapeutic program. Whether you are developing gene therapies, mRNA medicines, or DNA vaccines, plasmid DNA is a critical material that must meet the highest standards of quality and purity, especially for clinical translation.
With the growing demand for innovative therapies and increasing regulatory compliance requirements, choosing VGXI as your trusted plasmid manufacturing partner helps safeguard your program against unwanted setbacks. As a US-based CDMO, VGXI has state-of-the-art facilities, end-to-end expertise in plasmid DNA manufacturing, leading-edge technologies, and a secure supply chain. VGXI provides comprehensive support across all scales and stages of development, from preclinical research to full-scale GMP commercial production.
Over 20 Years of Plasmid Expertise
Since 2004, VGXI has been an integral part of the biopharmaceutical marketplace. Since then, we have grown our manufacturing capabilities and refined our patented processes to provide high-quality plasmid DNA to meet phase-appropriate requirements with unparalleled speed and cost efficiency. We produce high-purity DNA plasmids for pre-clinical research, highly documented (HD) DNA plasmids for IND-enabling toxicology studies and for ancillary raw material, and injectable-grade GMP DNA plasmids for clinical trials through commercialization.
We have produced more than 300 GMP batches of clinical-grade plasmid DNA for clinical trial evaluation and commercial supply of DNA vaccines. Our GMP and non-GMP products adhere to stringent international regulatory guidelines. VGXI also played a crucial role in domestic rapid response efforts during the SARS-CoV-2 pandemic, completing the manufacturing of a COVID-19 DNA vaccine in April 2020.
Patented Manufacturing Technologies
Our patented manufacturing processes, including our AIRMIX® lysis technology, enables high-purity, high-concentration plasmid production from 1mg/mL to 15mg/mL, suitable for low-volume and multi-plasmid formulations. We have optimized downstream chromatography steps to reduce batch production times and provide substantial cost savings for our clients. Furthermore, our experienced process development team and flexible manufacturing infrastructure enable us to offer custom manufacturing solutions for challenging plasmid constructs and bespoke project needs.
VGXI’s manufacturing facilities: The Woodlands (left), and Deison Technology Park (right).
Texas-Based Manufacturing Facilities
VGXI operates from two strategically located facilities – our original site in The Woodlands, Texas, and our new, state-of-the-art 120,000 ft2 headquarters and manufacturing facility located on 22 acres at Deison Technology Park (DTP) in Conroe, Texas. With a combined 160,000 ft2 of fully invested space, VGXI’s facilities are designed to meet the dynamic demands of the biopharmaceutical industry, and are fully compliant with FDA, EMA, and other global regulatory standards. For more information about VGXI’s expansion plans, read our blog The World’s Largest Plasmid DNA Manufacturing Capacity, highlighting VGXI’s capabilities to serve drug developers across the globe.
With a combined 160,000 ft2 of fully invested space, VGXI’s facilities are designed to meet the dynamic demands of the biopharmaceutical industry, and are fully compliant with FDA, EMA, and other global regulatory standards.
Our new headquarters at DTP is equipped with multiple flexible production suites and four independent manufacturing trains to accommodate GMP fermentation production up to 1,500L. The facility leverages a separate process development space and dedicated GMP cell banking areas. The facility also has micro-processing suites for rapid GMP manufacturing of personalized medicines and an automated GMP aseptic fill/finish line for final formulation and vial filling of drug products (e.g. 2 to 10mL).
Designed for Future Growth
Our facilities are equipped to manage current industry demands and are also designed for future growth. DTP’s current layout includes significant ready-to-go space, which gives VGXI the ability to rapidly increase our production capacity without additional buildouts. Coupled with our roadmap to expand our Texas footprint, VGXI plans to acquire an additional 21 acres at DTP for new manufacturing space, which will significantly expand our existing U.S. capabilities.
Secure Supply Chain
With supply chain disruptions becoming increasingly common across various sectors, ensuring a reliable and secure source of critical materials has never been more critical. VGXI has cultivated relationships to establish a well-developed network of key vendors over the past two decades. Our streamlined logistics and timely delivery of reagents help to minimize supply chain risks and avoid production delays.
Our streamlined logistics and timely delivery of reagents help to minimize supply chain risks and avoid production delays.
Robust Technology Transfer Processes
Transferring a manufacturing process from a lab-scale process or another manufacturing partner to a new facility is a daunting task. Our experienced multidisciplinary team works closely with clients to understand your specific program needs. VGXI experts are the best at offering detailed project outlines early on to ensure clarity, transparency, and suitability. Our technology experts provide comprehensive support throughout the transfer process to minimize downtime and ensure projects stay on track.
Speak with Us Today
When you choose VGXI, you are partnering with a CDMO that is as committed to your success as you are. Whether you are a start-up looking to scale up or further along in your development journey, VGXI has the plasmid DNA manufacturing expertise, regulatory acumen, and client-centric focus to help you achieve your goals. Contact us today!
