April 1, 2016 (Vol. 36, No. 7)

New Zealand Locale Provides “Air Gap,” Keeping Bovine Products Far from Madding Influences

The world’s largest processor of bovine serum albumin (BSA) opened a second facility in February, half a world away from its headquarters in Iowa. As Stephen J. Welch, Proliant Biologicals’ president and CEO, explains, the Feilding, New Zealand location lowers the business continuity risks for pharmaceutical clients.

“New Zealand has never had an outbreak of bovine spongiform encephalopathy (BSE), also known as ‘mad cow’ disease. New Zealand also has excellent traceability, controlling the herds and the feeds used. Most of the cattle are grass fed,” Welch says, which further reduces the risk.

“Our facility there will process only New Zealand-sourced material, enabling Proliant to supply the world with New Zealand BSA,” he continues.

“This new plant will open some markets that traditionally have been closed to U.S. bovine products,” Randal Fitzgerald, Proliant’s COO, adds. The New Zealand location also provides closer proximity to growing Asian markets.

Perhaps most important, the new facility helps ensure supply-chain continuity to Proliant’s clients throughout the world. “We’re the only BSA company in the world with two manufacturing locations,” Welch says. “Many of our customers make very expensive diagnostic tests and drugs. Relying on a company with a single manufacturing location for BSA that is used for billion-dollar markets concerned them.”

To bolster confidence in BSA availability, Proliant opened the New Zealand facility half a world away from its Iowa site, using the premise that distance will prevent any natural or geopolitical events from affecting both facilities. Customers, therefore, have a high degree of assurance that their supplies of BSA will not be interrupted, notes Fitzgerald.

Proliant Biologicals’ bovine serum albumin facilities in the United States and New Zealand both run closed-loop collection and processing systems. The New Zealand facility, shown here, was opened half a world away from the original U.S. facility to decrease the likelihood that both could be disrupted by the same natural or geopolitical events.

State-of-the-Art Processing

The new, $25 million New Zealand plant duplicates Proliant’s Boone, Iowa facility. Both are 50,000 square feet and feature the latest filtration and centrifuge technology. Combined, Welch tells GEN, they have the surge capacity to meet the BSA needs of any blockbuster products that may be commercialized.

“The New Zealand plant was built to meet FDA and other international guidelines for pharmaceuticals,” Fitzgerald says. It is inspected by New Zealand’s Ministry of Primary Industries, the equivalent of the U.S. Department of Agriculture (USDA).

“The key pieces of equipment in the New Zealand facility were sourced from the same vendors we use in the United States,” Fitzgerald continues. Other pieces use the same designs but were built locally. “New Zealand has an extensive dairy business, so it also has a robust stainless-steel industry.”

The Iowa plant on which this facility was modeled opened in 2001. A 10,000-square-foot lyophilization suite was added in 2007. Then, in 2013/2014, the overall plant size expanded to 50,000 square feet. With just that facility, Welch says, Proliant “can produce about as much BSA as the world uses each year.”

Closed-Loop Processing

Both the U.S. and New Zealand facilities run closed-loop collection and processing systems and collect the blood themselves. That reduces the potential for atmospheric contamination.

“We own the blood-collection equipment in the packing houses, as well as the tankers that bring it to our plants,” Welch emphasizes.

“Our plasma has edible-grade certification from the USDA. No one else has that,” he says while pointing out that the endotoxin level and bioburden are low and are virtually free of protease. “Because we start with clean, edible plasma,” Welch adds, “we have a consistent product.”

BSA Applications

BSA is a component of blood plasma, sometimes called Fraction V, and is a foundational component of the modern life sciences industry. Not only is BSA used for vaccine and monoclonal antibody production, it also serves as a nutrient for cell and microbial cultures and assay kits.

“All the industries we serve are continuing to grow. As the standard of living improves in developing nations, the demand for healthcare increases. That increases the use of BSA,” Welch declares.

Besides enhancing BSA production, Proliant is developing animal extracts and working to reduce the industry’s dependence on fetal bovine serum (FBS).

Proliant is a privately held, family-owned company. Welch himself has been with Proliant 24 years. It is one of eight companies within the Lauridsen Group, which generates more than $1 billion in annual revenues.

Proliant Biologicals

Location: 2425 SE Oak Tree Court, Ankeny, IA 50021

Phone: (515) 480-3205

Website: www.proliantbiologicals.com

Principal: Stephen J. Welch, President and CEO

Number of Employees: 60

Focus: Proliant Biologicals reportedly is the world’s largest processor of bovine serum albumin. Its newly opened plant is located in New Zealand because of its isolation and to reduce the risk of disease outbreaks among herds.

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