Banking on biotherapeutics

MADISON, Wis.—Biologics are experiencing a renewed growth inthe pharmaceutical industry, states Tom Livelli, Promega Corp.'s vice presidentof life sciences products and services, as organizations cut back onsmall-molecule screening and place more resources on biotherapeutics. To helpaccelerate this trend, Promega and the American Type Culture Collection (ATCC)have formed a partnership for the cell banking and bioproduction of cells tocreate a new line of bioluminescence-based drug discovery assays for biologics.

In the partnership, ATCC of Manassas, Va., will produce andauthenticate 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 cellassay systems for biologics. Promega will launch an Antibody DependentCell-mediated Cytotoxicity (ADCC) reporter bioassay in 2011 as the firstproduct resulting from this partnership.

The development of the ADCC reporter bioassay was initiatedin Promega's R&D efforts prior to execution of the agreement between Promegaand ATCC, Livelli notes.

"We brought representatives of ATCC to Promega early on todemonstrate our capabilities in cell-based assay development and discuss thedevelopment of much needed cell-based assays for the biologics market. Fromthat initial interaction, we agreed to collaborate on providing the ADCC assayto 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. Therewill be an enabling model launched in late 2011 prior to the kit products."

The ADCC reporter bioassay will meet a particularly critical need for nearlyall antibody-based biologics drug discovery programs worldwide. Manufacturersof therapeutic monoclonal antibodies, which are a significant proportion of thebiologics pharmacopeia, currently utilize lot-release assays that exhibit highvariability, are tedious and complex to perform and often require cellisolation from blood to provide effector cells, Livelli observes.

"The new assays, especially the ADCC reporter assay, willprovide a lot release assay with greatly reduced variability, an assay that iseasy and faster to perform, and perhaps of most interest to the market, cellsin 'frozen, thaw-and-use' format that contribute to all of the above-mentionedbenefits," he states. "Promega's assay systems for biologics will bring thesensitivity, ease of use, dynamic range and other features of bioluminescenceto the bioassay market. These features result in significant benefits to biologicsresearchers, primarily in reduced assay variability and faster time to data. Inaddition, these assays are based upon Promega's well established and acceptedluminescent detection technologies that have been a foundational tool insmall-molecule discovery for decades."

Livelli notes that Promega, and the scientific communitygenerally, recognizes the experience and expertise of the ATCC in cell bankingand bioproduction of biologic materials, specifically cell lines. Bothorganizations recognized the opportunity to combine the biological content ofthe ATCC with Promega's strong capabilities in detection technologies and assaydevelopment to generate complete assay systems. ATCC is a private, nonprofitbiological resource center and research organization whose mission focuses onthe acquisition, authentication, production, preservation, development anddistribution of standard reference microorganisms, cell lines and othermaterials for research in the life sciences. The organization is overseen by aboard of directors composed of 12 members drawn from leaders in the scientificand business communities who advise the president and CEO on organizationalbusiness matters. The day- to-day operations of the organization are managed byan executive governance team and by the ATCC president and CEO to ensurecompliance with ethical, regulatory and quality best practices. ATCC is an ISO9001:2008 certified, ISO/IEC 17025:2005 and ISO Guide 34:2009 accreditedorganization.

"We are extremely pleased to work with Promega in bringingtheir assay innovations to drug discovery researchers," says Dr. SherryChallberg, senior director of corporate development.

ATCC President Dr. Brian Pollok adds, "we are excited tobegin a venture of working with technology-based companies like Promega in thearea of cellular assay product development."