Proliant Announces 100% "Closed-Loop" BSA Manufacturing With a New Lyophilization and Packaging Suite

Business Wire, April 28, 2008

ANKENY, Iowa -- Proliant Health and Biologicals, a pioneer in novel, environmentally closed methods for BSA production, has taken its "Closed Loop" manufacturing a major step forward. The company recently opened a high-tech, dedicated drying and packaging suite for isolation of all BSA products. The new facility incorporates many process innovations and includes one of the largest and most efficient biological lyophilizers (freeze-driers) in the world.

BSA is a critical component of medical diagnostic assays, life science research reagents, microbiological media and pharmaceutical/veterinary culture media. "We are already the only company that personally touches every aspect of its production. We own the collection and transport of raw material for production of BSA, which really is a must for true consistency and traceability." said Randy Fitzgerald, Executive VP of Operations for the company. "Now we have introduced a finishing suite that gives us a superior ability to isolate and control the product during the critical drying and packaging phase."

The innovations introduced by Proliant include a sterile bag-in-tray system and fully dedicated stainless-steel chamber that ensures the product remains contaminant-free during the drying cycle. The chamber is unloaded into an integrated, HEPA-filtered and monitored dry clean room for sifting and packaging.

The new suite extends the company's longstanding focus on setting new standards for production and consistency of animal-derived biologicals. "The idea that you could produce higher quality, more consistent BSA in a controlled system, absent of decades-old batch and solvent methods, truly revolutionized the industry since Proliant entered the market in 1999," said Michael Budnick, Executive VP Sales and Marketing. "This philosophy, plus good old-fashioned customer service and integrity, has allowed Proliant to grow exponentially and now serve more than half the world market for bovine albumin."

Strong process control throughout raw material sourcing and collection, fractionation, and drying/packaging has allowed Proliant to avoid the pitfalls of some manufacturers who still offer a confusing array of BSA grades. These "choices" are often just the same BSA of varying quality, trumped up by clever marketing as "specialty products", but really representing an inability to meet exacting specifications with every lot.

Instead, Proliant's relentless focus on the process allows the company to economically produce the highest quality product every time, without cherry-picking for "specialty grades". Each lot of Proliant BSA is engineered from the start to be low endotoxin, low bioburden, and virtually protease and IgG-free; and every lot of Fatty-Acid Free has the lowest levels in the industry. Besides reducing costs, the simplified, first quality product line means that just a few product grades work well the first time in a wide spectrum of applications.

"Our process is a head-and -shoulders above industry standards for animal-derived products, where ancient cast-iron jet driers, food-grade contract toll driers and open-tray systems have predominated," added Fitzgerald. Such conditions can lead to high bioburden or introduce particulate contamination that affect the safety and consistency of the product.

Proliant Health and Biologicals is part of the Proliant group of companies, leading manufacturers of animal-derived proteins and carbohydrates. Founded in 1981 and headquartered in Ankeny, Iowa, Proliant along with APC, BHJ Corporation and Boyer Valley Corporation are privately held companies of the Lauridsen Group Incorporated (LGI). With over $600 million in sales and 36 manufacturing locations worldwide, LGI serves human, veterinary and industrial applications with high quality, natural source products.