New-tech vaccine plant balances GMP with sustainability

By George Miller

At the opening of its vaccine-production plant in May, Novavax Inc. president and chief executive Rahul Singhvi, Sc.D., trumpeted not just the company’s new vaccine technology but also the environmental sustainability features of the production process and, hence, the facility.

“It incorporates new processes to increase production yields with significantly less infrastructure and capital cost compared to current approved vaccine facilities,” said Singhvi at the opening of the company’s 5,000-sq.-ft., $5 million pilot- and commercial-scale manufacturing showcase in Rockville, MD.

“Our production technology, combined with our use of disposable materials, offers the potential advantage of simple portability of production equipment to sites around the world, where vaccines may be urgently needed,” he continued.

Singhvi’s comparison to current vaccine facilities is a bit of an apples-to-oranges one, in that traditional facilities house the many eggs used to grow viruses for vaccine production (which require temperature-controlled storage space) as well as older-technology stainless-steel production gear. The relative savings, due to smaller size (the Novavax facility is about one-third the size of a traditional plant), plus elimination of egg storage and a manufacturing process that requires less heat removal, yields utility costs for heating, ventilation, and air conditioning of about 25% of those for a traditional facility, says Jim Robinson, vice president for manufacturing.

Eliminating egg logistics

The Novavax vaccine technology, based on the company’s virus-like particle (VLP) and Novasome adjuvant technologies, dispenses with the eggs and their storage requirements, and replaces more high-maintenance stainless-steel processing equipment with disposable plastic technology. The VLP technology yields vaccines that closely match the disease-causing viruses while lacking the genetic material to cause disease.

The new facility is, in fact, an operational form of a construction model that Novavax and partner GE Healthcare plan to use to showcase the process and facility setup that would enable health officials worldwide to produce their own vaccines, within their own borders–a big consideration given inevitable border closings during a pandemic.

In the meantime, the facility will be used to produce influenza vaccine for the company’s current clinical programs, with planned annual capacity of 10 million doses.

“It’s almost underwhelming from a manufacturing perspective, it’s so uncomplicated,” Robinson explains. “The disposable manufacturing platform allows you to manufacture in a much less elaborate facility. No clean-in-place (CIP) equipment is needed, and product contact is minimized due to the disposables.”

Shifting process responsibility

And the use of disposables–despite the necessity of disposing of them–is key to the environmental sustainability of the facility. “We’re trading one set of issues for another,” says Robinson, “shifting responsibility to the bag vendors to come up with processes that will not affect the product. We validate the process they use to sterilize bags. Then we connect the bags and run the process.”

Bag disposal remains a work in progress for the plastics and biotech industries. Because bags are made of multiple polymers in layers, they are a recycling challenge. “We will work with the county to see what can be done,” says Robinson. “Plus, the plastic bag industry is pursuing the conversion of used bags to fuel. That may be a solution.”

Novavax president and CEO Rahul Singhvi says that his company’s non-traditional vaccine production technology requires less infrastructure and uses disposable bioprocessing systems, aiding in environmental sustainability. Photo courtesy of Novavax.
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The manufacturing facility is built within what was previously a quality control lab that incorporated Class C (10,000 class) air handling, appropriate for the low-bioburden work, and one Class A (100 class) hood. Cell culture is also managed under Class A.

“The rest is under a totally closed system,” says Robinson. “That’s where disposables really help.” Novavax uses the GE Healthcare Wave bioreactor for cell culture. The system allows the culture medium and the cells to contact only a pre-sterilized, disposable chamber (the Cellbag), which sits on a rocking platform for mixing. The bioreactor requires no cleaning or sterilization, according to GE Healthcare documents.

The use of disposables provides other savings as well, he says. “We can build a facility that is less than a quarter of the cost of an egg-based facility, one-tenth the cost of cell culture facility for influenza. And we can use smaller-scale systems, so we don’t have to worry about big toxic spills.”

Cooperative design effort

Novavax engineers and manufacturing managers worked with Jacobs Engineering Group Inc. (Pasadena, CA) to design the facility. “We defined process, they designed the facility,” says Robinson.

GE Healthcare, manufacturing half of the disposable systems that Novavax uses today, is the majority supplier, as well as partner in the collaboration announced last December to develop and market a pandemic flu vaccine manufacturing solution for select international markets. The collaboration is aimed at health planners around the world who want to establish or increase manufacturing capacity and vaccine stockpiles to counter the threat of global avian influenza pandemic.

According to Novavax, the global demand for pandemic flu vaccines has been reported as possibly approaching 13 billion doses, with current world capacity at some 2.4 billion doses at best.

The Novavax VLP-based H5N1 pandemic flu vaccine is currently in clinical trials. The vaccine production system incorporates GE Healthcare’s ReadyToProcess disposable systems and devices for bioprocessing.

Regulator leads by example in sustainable design project

At the behest of the Department of Health and Human Services in its 2008 update of the Real Property Asset Management Plan, the U.S. Food and Drug Administration (FDA) has designated the Arkansas Regional Laboratory (ARL), a part of the Jefferson Laboratory Complex in Jefferson, AR, a sustainable design project. Such a project emphasizes design features including recycled building materials, energy conservation measures, and natural landscaping techniques to save resources.

The complex is a 500-acre campus comprising some 60 labs, office buildings, and outbuildings. The project came with a $400,000 budget request, part of the $5 million requested for new construction and repairs and improvements to existing facilities, according to FDA documents.

According to the HHS Sustainable Buildings Implementation Plan of March 2007, construction projects of $3 million or more require certification (either the Green Building Initiative’s Green Globes [] or the U.S. Green Building Council’s LEED, for Leadership in Energy and Environmental Design []).

Mandatory requirements, each of which is defined in the HHS document, include the following categories:

  • Integrated design including integrated project team, performance goals, and life cycle cost analysis
  • Commissioning
  • Energy performance
  • Water conservation
  • Ventilation and thermal control
  • Moisture control
  • Daylighting
  • Low-emitting materials
  • Indoor air quality during construction
  • Recyclable content
  • Biobased content
  • Construction waste
  • Ozone-depleting compounds

Mandatory goal categories for major renovations include the following:

  • Green certification for projects of $3 million or more
  • Integrated project team
  • Energy performance
  • Water conservation
  • Ventilation and thermal comfort
  • Moisture control
  • Indoor air quality during construction
  • Recycled content
  • Biobased content
  • Construction waste
  • Ozone-depleting compounds


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