Photo credit: Gina Hann

Maryland Biotech Opens New Gene Therapy Contract Manufacturing Facility To Support Rapid Growth

Grand Opening Event “Marks a Great Day” for Rare Disease Patients and Families, and a company in pursuit of a noble mission.

Vigene Biosciences officially opened its new, state-of-the-art 51,000 square foot cell and gene therapy manufacturing facility in Rockville, Maryland at a ribbon-cutting ceremony on January 29th.

The grand opening marked a major milestone for the company, which has grown from three employees to approximately 100 team members since launching in 2012. The $20M project has increased Vigene’s footprint to 71,000 total square feet, amplifying its capacity to serve its clients and achieve the company’s ultimate mission: Making gene therapy treatments more affordable for people and families battling cancer and genetic disorders.

The ribbon-cutting ceremony was a vibrant, joyful celebration of Vigene’s remarkable achievements. It was also a moment of real hope for families seeking better, more affordable gene and cell therapies for loved ones stricken with cancer and rare diseases.  

Gina Hann, the founder of the non-profit organization Batten Hope, was Vigene Biosciences’ grand opening special guest. Her seven-year-old son, Joseph, known as JoJo, was diagnosed with a rare form of Batten disease at age five. Batten disease is a terminal, genetic, neural-degenerative disease. Hann spoke to the rapt crowd about her family’s experiences and her son’s courageous battle with Batten disease.

“I want everyone in this building to understand why the work that you are doing is so, so important. This is a great day for the rare disease community, and in case you’re wondering who this community is I want to give you a sense of it: one in ten. Look around this room and how many people are here. One in ten are impacted directly by rare disease,” stated Hann.

“This is a great day for all of us and especially for all of the children that face rare disease like my son Joseph…I just wanted to say thank you so much for your hearts and hard work and all of your great innovation. You are absolutely changing the world for the better…You guys are making that one shot for our kids. Thank you,” she added.

Vigene Biosciences has been an ardent supporter of Batten Hope and a stalwart advocate for the patient community. The company’s growth expanded production capacity and focus on increasing manufacturing efficiency will help drive down therapy costs for families like the Hanns.

On a Mission to Reduce Gene and Cell Therapy Costs

While revolutionary cell and gene therapies offer new hope and promise for treating previously untreatable diseases, gene and cell therapies approved by the Food and Drug Administration (FDA) are some of the most expensive therapies available. For example, Zolgensma, a highly effective gene therapy treatment for spinal muscular atrophy (SMA) is the most expensive drug in the world at $2.125M per treatment.

Reducing R&D and manufacturing costs through innovation and greater efficiency is the key to making these critical therapies more affordable to patients in the U.S. and across the globe. With some 4,000 life science companies in its current and former client portfolio, Vigene will play a pivotal role in this effort.

Vigene Biosciences partners with cell and gene therapy developers, providing these companies with the viral vectors needed to develop new cell and gene therapy products. The company’s increased manufacturing capacity and future hiring plans will help accelerate the production of high-quality AAV, Adenovirus and Lentivirus materials and plasmids, which are often difficult to find in the required quantities.

“The grand opening today is a major milestone for Vigene. The new facility will enable us to serve our clients faster and better. Six years ago we had two employees and 300 square feet of space. Now we have 100 employees and 71,000 square feet of space across three locations. We expect to double or triple our staff and workforce over the next two or three years,” stated Dr. Zairen Sun, Vigene’s Founder, Chief Executive Officer and Chairman of the Board.

“In gene therapy, GMP manufacturing is very complicated and it is currently a bottleneck. There is a huge shortfall in materials. In five years, we will need 50 to 100 times more capacity than what is available today. If we can achieve this capacity we can make gene therapy more affordable to patients and we can continue to make a difference in people’s lives. If you think about what we’re doing every day, we are saving lives…we have the facilities now to serve our clients better,” he added.

The new Rockville facility, which took three years to complete, expands its total number of GMP (Good Manufacturing Practice) suites to ten and includes a fill/finish suite and a facility that’s unique to Vigene’s vertical integration strategy — its own plasmid production facility. Plasmids are a key raw material for gene therapy production. The new facility allows Vigene to produce plasmids independent of outside vendors. The plasmid facility can produce injection ready grade and research-grade materials in house, which is a rarity in the industry. 

Vigene’s vertical integration approach empowers the company to take gene therapy all the way from concept through commercialization, faster and at a lower cost than its competition. With seating for up to 200 employees, the new facility meets the company’s current manufacturing and staffing needs, bringing its core team under one roof, and can accommodate the organization’s aggressive future growth projections.

Vigene Aggregates and Strengthens Montgomery County Footprint

The grand opening of its Rockville global headquarters dovetails with the company’s recent announcement of a major manufacturing partnership with ACS Therapeutics, a gene therapy company based in California. The partnership with ACS Therapeutics is just the latest signal of Vigene’s rapid, sustained and smart growth over the last several years. In 2018, Vigene was ranked 81st on the Inc. 5000 list of fastest-growing private companies. The company also holds four patents, has highly sought after IP and now has an even larger footprint in Montgomery County, Maryland’s burgeoning cell and gene therapy hub.

Ben Wu, CEO of Montgomery County’s Economic Development Corporation, spoke at the ribbon-cutting ceremony, stating,” We are so pleased to be here to help commemorate this important and auspicious occasion. What we see here is not just a wonderful facility and a wonderful company, we see a promise and a commitment that Vigene continues to make to Montgomery county and the state.”

“They say you can tell a lot about an organization by the company they keep. We have a network and a cluster that continue to make this area one of the top clusters in the country. We are deeply grateful and we will continue to do everything we can to support Vigene and other local companies. We do this because the cell and gene therapy being conducted here is so important because it offers that glimmer of hope to Gina’s son, JoJo, and other kids like him,” he added.

Dr. Jeffrey Hung, Vigene’s Chief Commercial Officer, offered a toast to conclude the ceremony that spoke to the deep connection between Vigene Biosciences, the cell and gene therapy companies it supports and patients and families searching for a cure.

“This is so exciting. Welcome to our new home. I want to take a moment to reflect on Vigene’s purpose. One of my most memorable and inspirational nights was spent at the Hann’s home where I met JoJo…Suddenly I realized that we are involved with something much bigger than ourselves. Vigene exists to deliver the cures and the hope to patients. Gene therapy manufacturing is not easy. We work hard to make gene therapy affordable for patients like JoJo…Here’s to the cures. And here’s to the hope.”

On January 29th, Vigene Biosciences launched much more than a new phase in its history; it ushered in a new era of hope for JoJo, the Hann family and other patients and families suffering from rare diseases and cancer. 

Leave a Reply

Your email address will not be published.

This site uses Akismet to reduce spam. Learn how your comment data is processed.