Fighting the flu

Millipore and Microbix to co-develop novel purification process in influenza vaccine manufacturing

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TORONTO—Millipore Corp. is collaborating with Microbix Biosystems Inc. to improve influenza vaccine manufacturing by developing a purification process using novel chromatographic technology, according to an announcement made last month.

As part of the collaboration, Millipore plans to develop a new technology for single-step purification of influenza virus to replace ultracentrifugation. Influenza vaccine is currently produced in eggs and is purified using ultracentrifugation. Ultracentrifugation is an expensive and complex process that can create bottlenecks in process development during manufacturing scale-up. The single-step purification process, based on novel chromatographic technology being developed by Millipore, has the potential to reduce the complexity and capital cost associated with current manufacturing processes.

Terms of the agreement, including development rights, have not been released.

Microbix, a virology company in business for more than 25 years, has the expertise in virology and molecular biology to innovate, the facilities especially designed to accommodate this kind of development and the background in virus manufacturing needed to create new methodologies, says President Phil Casselli. Use of the company's Virusmax technology will "ensure that maximal yields are realized in process development studies and provide greater flexibility in the choice of virus strains for influenza vaccine applications," he says.

"This is the specialty upon which we have built our business," Casselli adds. "Microbix made a discovery that the influenza vaccine industry had missed which is that up to 80 percent of the virus produced in eggs is attached to the insoluble debris that is discarded in the manufacturing process."

Microbix will supply egg-based influenza virus for use in product development studies. The company also will transfer the Virusmax technology to Millipore so both companies can integrate the collaboration and training Millipore in integration of Virusmax.

According to Jean-Paul Mangeolle, president of Millipore's Bioprocess Division, the company remains focused on pioneering innovation for the biopharmaceutical industry.

"Developing new vaccine purification technologies that improve both the efficiency and economics of manufacturing is of paramount importance to us," says Mangeolle.

In the wake of the recent outbreak of the H1N1 flu virus, both companies realized that the current influenza process could benefit from a renewed evaluation of new technology as applied to purification. Current vaccines are produced with methods that date back as much as 30 years.

"We have the opportunity to significantly lower the capital cost and complexity of the current process," says Bob Shaw, program director of Vaccines and Emerging Biotech at Millipore. "So while seasonal influenza is an important disease and vaccine that deserves significant attention, the advent of the H1N1 outbreak has certainly focused our attention on the need to develop a new approach to purification."

Microbix also is collaborating with Health Canada and the Centers for Disease Control (CDC) in Atlanta to confirm yield improvement using Virusmax on the new vaccine H1N1 strain being supplied to all manufacturers.

The market for influenza vaccines is estimated to be more than $2 billion today, and threat of an expected pandemic is expected to double this market by 2016. This research will be conducted in Millipore's vaccine process research laboratory in Bedford, Mass. The lab focuses on new technologies for conventional vaccine manufacturing as well as new single-use processes.

The H1N1 outbreak also has produced a sense of urgency to create new processes, increasing vaccine capacity in manufacturing plants.

"Companies can either produce vaccine in half the time normally required or produce twice as many doses of vaccine," notes Casselli.

As for short- and long-term goals of the collaboration, Shaw said the short-term goal is to demonstrate that Virusmax can improve upon Millipore's performance in developing technologies with the flu vaccine production processes.

"The long-term goal is to offer a combined Millipore/Microbix production process capable of delivering capacity increases in the order of two- to four-fold over current processes and providing a reduction in the time required to manufacture large quantities of vaccine," says Shaw. "Both of these changes are extremely important during a time of virus outbreak to respond to the particular variations that are presented."

Shaw said short-term success will be development of prototype processes, while a long-term success would be will be installations utilizing the technology improvements in the production of influenza vaccine.

Short-term, Millipore will be looking to develop a simplified process that replaces ultracentrifugation with chromatography and provide the industry with a significant simplification to its processes, Shaw says.

"This is especially important for those countries that are thinking about implementing influenza virus manufacturing," he says.

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