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Mar 1, 2011 (Vol. 31, No. 5)

CMOs Seek "the" Competitive Edge

Established Practices Like Lyophilization and Six Sigma Are Finding Novel Uses in Biotech

  • Lyophilization

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    Lyophilized collagen scaffolds are being developed at Oregon Freeze Dry to hold vaccines and other therapeutics, allowing for elimination of the cold chain.

    Lyophilization is a mature technology that is finding new uses in biotech. Oregon Freeze Dry is using this low temperature, low-pressure preservation method with biopharmaceuticals, specialty chemicals, medical devices, active pharmaceutical ingredients, and finish delivery formats to provide novel delivery solutions. It is beneficial when heat, oxygen, and/or shear prevent efficient production or efficacious final products.

    “We are finding limitless opportunities to preserve the form and functionality of materials for topical, implantation, or oral delivery of specific moieties,” according to Walt Pebley, vp.

    Currently, Oregon Freeze Dry is working with PATH, an international nonprofit health organization based in Seattle, to evaluate lyophilization as a delivery vehicle for oral vaccine quick dissolve, thus eliminating the cold chain and therefore extending the benefits of certain vaccines to developing countries. This technology also makes it possible to give full dosage of vaccines to babies without using needles. “The efforts require the fusion of vaccine culturing with cryopreservation, freezing, lyophilization, and unique packaging,” he says.

    Oregon Freeze Dry is also assessing lyophilization as a way of stabilizing scaffolds for wound care. “We are creating emulsions of hydrogels, collagens, and specialty chemicals for dispensing into unique freezing apparatus that control ice nucleation, to form a crystal structure for the resulting lyophilized scaffold,” Pebley explains. “The next step is to incorporate compatible active ingredients homogeneously into the scaffold matrix, either before or after lyophilization, depending upon the stability requirements.” That approach provides “an elegant method for preserving form and function.”

    In the specialty chemical area, Oregon Freeze Dry is using lyophilization to “preserve or maximize the internal surface area of materials to increase the productivity of catalysts, activated carbon and nano materials,” Pebley adds. “It appears that the principals of lyophilization can be applied across a much broader spectrum of applications than we previously thought.”

  • Contamination

    Microbial contamination is a key concern of many biopharmaceutical manufacturers, yet “there is a reluctance on the part of nonmicrobiologists to take action about microbial issues,” according to Joseph McCall, senior group leader, sterile operations for DSM Pharmaceuticals. The main areas nonmicrobiologists should focus on, he says, are surface and equipment design, cleaning parameters, and disinfection and sanitization.

    “Identifying the contaminant is easier said than done,” McCall admits, “but it may lead to identifying the source of contamination.” At that point, he advises examining the cleaning strategies. “Experiment and demonstrate effectiveness against your known contaminants. Personnel-borne contaminants like Staphylococcus require a different strategy than those introduced by a system or process.”

    “Disinfection and sanitization processes must be tailored to the unique situation,” McCall stresses. “Understand what it is capable of doing within the system. For example, a biofilm that coats the interior of pipes may need chemical obliteration rather than steam sterilization.”

    McCall also recommends looking closely at the facility’s physical layout. “Walk through the engineering layout to identify dead legs—areas of piping in a circulating system where liquid can collect without being recirculated.” Also, look at piping slopes. “Bacteria don’t walk. Gravity and orientation play a role. For example, if you identify a dead leg, but the area of concern is four stories up, with bends in the pipes, it may be relevant.”

    The message, McCall says, is this: “Understand that wear and tear exists, and systems that were once validated may no longer meet those standards.”

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