Antibody Purification Needs
"Companies continue to strive for improvements in yield and quality of antibody products, while also seeking faster process implementation and scale-up," according to Fred Mann, Ph.D., technical marketing manager of the bioprocess division at Millipore (www.millipore.com). "With these needs in mind, we have focused on improving our purification technology through the development of disposable modules for clarification and prefiltration of biological solutions."
Millipore recently carried out an industry-wide survey of managers in the field of antibody process development and manufacturing to assess their performance indicators and how these could be improved. The survey showed that most companies are focused on cycle time, deviations, and manufacturing cost. The most prevalent reason listed for deviations were procedural issues, and the solution initiated most frequently by the companies surveyed was improvements in error proofing.
Another area investigated in the survey was operational improvements that managers felt would best help them to meet their manufacturing goals. Innovations in cell culture and fermentation were the most frequently cited, supporting the belief that even though yields per cell have exploded in recent years, there is still much room for further increases. Next in order of priority came process chromatography followed by clarification.
For several years Millipore has offered Millstak+HC filtration media units, a disc-shaped technology comprising filtering systems for the clarification of cell culture harvest fluids. However these filters have some disadvantages, including bulkiness and handling difficulties.
To meet the challenges posed by Millstak+HC, Millipore has introduced its Pod platform as an integrated media housing unit consisting of lightweight, self-contained, disposable modules. The system, with its disposable feed ports and fittings, delivers improved flexibility and ease of use. It can be configured to handle 10,000- to 20,000-L batch volumes with greatly reduced buffer and washing requirements.
Because of these improvements, overall costs of operation can be considerably less than those obtained with traditional lenticular filters. For example, taking water and buffer cost savings into account, the Pod system was shown to be 13% less expensive compared to the lenticular system, according to Millipore.
Disposables are becoming more popular in the area of cell cultivation. So, the move into the downstream processing area is a natural extension of this convenient and labor-saving technology.
In addition to its products for media clarification, Millipore is also focused on the purification of antibodies. Its lead product, ProSep-vA Ultra, is a higher-performance chromatography media for Mab capture. Protein A is the most widely used antibody purification molecule, and in the last few years, variant forms of the molecule have been introduced that allow for improved purification.
"While there are other antibody purification molecules, such as Protein L and Protein G, available, Protein A continues to be the most versatile and adaptable," Dr. Mann said. "Our ProSep controlled pore glass-based Protein A resin is also designed to aid process development and implementation by providing high capacity and throughput coupled with robust scalability."