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Banking on biotherapeutics
MADISON, Wis.—Biologics are experiencing a renewed growth in the pharmaceutical industry, states Tom Livelli, Promega Corp.'s vice president of life sciences products and services, as organizations cut back on small-molecule screening and place more resources on biotherapeutics. To help accelerate this trend, Promega and the American Type Culture Collection (ATCC) have formed a partnership for the cell banking and bioproduction of cells to create a new line of bioluminescence-based drug discovery assays for biologics.
In the partnership, ATCC of Manassas, Va., will produce and authenticate cell banks and production lots of engineered and stock cell lines, which will be used as cellular reagents to create a new line of Promega cell assay systems for biologics. Promega will launch an Antibody Dependent Cell-mediated Cytotoxicity (ADCC) reporter bioassay in 2011 as the first product resulting from this partnership.
The development of the ADCC reporter bioassay was initiated in Promega's R&D efforts prior to execution of the agreement between Promega and ATCC, Livelli notes.
"We brought representatives of ATCC to Promega early on to demonstrate our capabilities in cell-based assay development and discuss the development of much needed cell-based assays for the biologics market. From that initial interaction, we agreed to collaborate on providing the ADCC assay to the market. Alpha testing of the ADCC reporter bioassay is almost complete, and full resources are being applied to launch the product in kit format. There will be an enabling model launched in late 2011 prior to the kit products."
The ADCC reporter bioassay will meet a particularly critical need for nearly all antibody-based biologics drug discovery programs worldwide. Manufacturers of therapeutic monoclonal antibodies, which are a significant proportion of the biologics pharmacopeia, currently utilize lot-release assays that exhibit high variability, are tedious and complex to perform and often require cell isolation from blood to provide effector cells, Livelli observes.
"The new assays, especially the ADCC reporter assay, will provide a lot release assay with greatly reduced variability, an assay that is easy and faster to perform, and perhaps of most interest to the market, cells in 'frozen, thaw-and-use' format that contribute to all of the above-mentioned benefits," he states. "Promega's assay systems for biologics will bring the sensitivity, ease of use, dynamic range and other features of bioluminescence to the bioassay market. These features result in significant benefits to biologics researchers, primarily in reduced assay variability and faster time to data. In addition, these assays are based upon Promega's well established and accepted luminescent detection technologies that have been a foundational tool in small-molecule discovery for decades."
Livelli notes that Promega, and the scientific community generally, recognizes the experience and expertise of the ATCC in cell banking and bioproduction of biologic materials, specifically cell lines. Both organizations recognized the opportunity to combine the biological content of the ATCC with Promega's strong capabilities in detection technologies and assay development to generate complete assay systems. ATCC is a private, nonprofit biological resource center and research organization whose mission focuses on the acquisition, authentication, production, preservation, development and distribution of standard reference microorganisms, cell lines and other materials for research in the life sciences. The organization is overseen by a board of directors composed of 12 members drawn from leaders in the scientific and business communities who advise the president and CEO on organizational business matters. The day- to-day operations of the organization are managed by an executive governance team and by the ATCC president and CEO to ensure compliance with ethical, regulatory and quality best practices. ATCC is an ISO 9001:2008 certified, ISO/IEC 17025:2005 and ISO Guide 34:2009 accredited organization.
"We are extremely pleased to work with Promega in bringing their assay innovations to drug discovery researchers," says Dr. Sherry Challberg, senior director of corporate development.
ATCC President Dr. Brian Pollok adds, "we are excited to begin a venture of working with technology-based companies like Promega in the area of cellular assay product development."