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Corporate Profile : Dec 1, 2007 (Vol. 27, No. 21)

Novozymes Tackles Ingredient Manufacture

Company Identified Opportunity and Plunged Ahead, With Several Products Already Offered
  • Carol Potera

Novozymes, a supplier of industrial enzymes and microorganisms, is expanding its base of operations to become a manufacturer of biopharmaceutical ingredients. “We have been involved in the microbial production of proteins for 45 years and have tremendous expertise,” says Greg Moss-Smith, sales director of Novozymes Biopharma (biopharmaceuticals.novozymes.com).

Although many people know Novozymes as a supplier of industrial enzymes, “most people do not know that we are a leading manufacturer of recombinant proteins,” he adds. In fact, in the past few years, Novozymes has filed more patents related to recombinant proteins than Amgen or Genentech, according to Moss-Smith.

The recent reorganization of Novozymes reflects the company’s strategic goal to diversify its base; its enzyme business has, historically, been a major focus.

As part of the restructuring, the company performed a review of the range of biopharmaceutical ingredients currently used in industrial cell culture. This revealed that recombinant proteins could address some of the issues associated with the production of biotherapeutics in mammalian cells. “Our aim is to use the industrial bioinnovations platform to launch the new biopharmaceutical ingredient segment,” says Moss-Smith.

Products currently offered by Novozymes Biopharma include recombinant proteins, sold under the trade names Long®R3 IGF-1 and DeltaFerrin™, which are added to cell culture media to enhance the growth of mammalian cells. Recombumin® is used for protein drug formulation and Albucult™ for cell-based therapeutics.

Novozymes gained the rights to Long R3 IGF-1, an analog of human insulin growth factor-1, by acquiring GroPep. DeltaFerrin, a yeast-derived recombinant human transferrin currently in development, and Recombumin and Albucult, which are application-specific recombinant human serum albumins, came with the acquisition of Delta Biotechnology.

All of Novozymes cell culture ingredients are animal-free, manufactured under GMP conditions, and capable of supporting optimal cell growth in a variety of cell lines, according to Moss-Smith, who adds that because the recombinant proteins are manufactured in a highly consistent manner, customers are insured a reliable supply of product.

“Anyone making a therapeutic protein in mammalian cell culture will find use for these products in upstream media culturing,” notes Moss-Smith. “Also, manufacturers of vaccines or medical devices coated with proteins like albumin will benefit from using the recombinant products.”

Older cell culture media relied on serum, a heterogenous mixture of proteins of varying composition. “People involved in media development want leaner and meaner media,” adds Moss-Smith. Customers want unnecessary components removed from serum, such as prions or proteins that slow cell growth, and they want purer components at lower costs.

“We want to define the least number of essential components of serum and reproduce them,” Moss-Smith reports. According to cell biology researchers, cells prefer to grow on proteins. So Novozymes “strives to give cells what they want in consistent, recombinant protein products,” adds Moss-Smith.

Long R3 IGF-1 and DeltaFerrin represent the start of a platform for mining key proteins from serum to optimize cell culture growth. As more proteins are identified and made on a recombinant basis, they will enhance the robust production systems of large biopharmaceutical customers. “Customers want platform technologies that will work consistently for each production run,” says Moss-Smith, to enhance high performance manufacturing.

U.S. Biofuels Initiative Expands

To better support its global customers that need biopharmaceutical ingredients, Novozymes Biopharma opened an office in Boston in October. In addition to the new Boston office for supporting biopharmaceutical ingredients, Novozymes is adding workers at its current locations in Franklinton, NC, and Davis, CA.

The expansion, mainly driven by the biofuels initiative within Novozymes’ enzyme business, includes workers in R&D, customer service, and marketing. “We’re placing our bets for when the second generation of biofuel production takes off,” says Thomas Nagy, evp of stakeholder relations.

The current first-generation enzymes convert corn and other starchy foodstuffs into bioethanol. These methods are criticized for driving up the price of corn and wasting water and energy. Second-generation enzymes will convert cellulosic biomass such as cornstalks or other agricultural residuals into bioethanol. “Novozymes is at the forefront of finding enzymes for the second generation of ethanol production,” Nagy notes.

Novozymes’ scientists have perfected the second-generation methods in the laboratory and are scaling them up for commercialization. The technology includes finding novel enzymes, process development, and applications to convert any cellulosic material into bioethanol at high yields. “This is our biggest research effort,” says Nagy, and “we are expanding our applications facility in Franklinton to enhance these efforts.”

Today’s U.S. bioethanol industry is centered in the Midwest and based around corn. Second-generation enzymes would allow any part of the country or world to establish a bioethanol industry based on local cellulosic biomass. When second-generation methods are perfected, Novozymes may build new facilities for manufacturing enzymes needed for bioethanol production. “We want to manufacture enzymes locally to better serve future customers,” Nagy says. The company is scouting locations across the U.S. for potential future facilities.

The biofuels initiative “is an example of how we can use biotechnology and genetic engineering to solve real problems,” Nagy says. Novozymes seeks biological solutions that create a balance between business growth, a cleaner environment, and better living. Second-generation enzymes for bioethanol production will save energy, water, and raw materials. “We can sustain our standard of living and at the same time create a better environment,” Nagy adds.