Vendor Notes: The Biovest AutovaxID: Enabling the Promise of Personalized Medicine - - BioPharm International

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Vendor Notes: The Biovest AutovaxID: Enabling the Promise of Personalized Medicine


BioPharm International
Volume 20, Issue 7

CAPABILITIES

AutovaxID is well suited for growing any antibody-secreting cell line, including hybridomas and Chinese hamster ovary (CHO) lines. In the case of our lead product, BiovaxID, patient-specific cell lines were created by fusing patient-derived tumor B-lymphocytes with an established murine heterohybridoma cell line. Since B lymphocytes, by themselves, are somewhat difficult to culture, and are poor ex vivo producers of monoclonal antibodies, fusion with another hybridoma line provides them with enhanced ability to proliferate and secrete their unique immunoglobulin. This immunoglobulin (IgG or IgM) is unique to each clonal cell population, and in this case, represents a unique tumor antigen. More specifically, the idiotype, or CD3 region of these immunoglobulins, is unique to each patient. As such, fusing cancerous B cells with an established hybridoma line gives us the ability to manufacture large quantities of tumor-specific protein, which is purified and used to immunize the patient against recurrence of lymphoma. In Phase 2 studies, BiovaxID has shown that after nine years 95% of treated patients are still alive and 45% remain disease free.


Figure 1
In addition to BiovaxID production, the AutovaxID is used routinely at the Biovest National Cell Culture Center to produce monoclonal antibodies for academic investigators. We believe the AutovaxID holds great promise in research settings because of the instrument's ease of use, robust operation, and high productivity.

A good deal of the AutovaxID's ease of use derives from its facile, straightforward setup. Once cells are introduced into the AutovaxID, the instrument takes over all significant aspects of the operation. Where preparation and setup can typically take several hours in conventional hollow fiber bioreactor systems, these operational steps have been reduced to less than five minutes in the AutovaxID. By eliminating this complexity, technician error and labor are significantly reduced, especially when multiple instruments are needed for concurrent production of numerous products.

The AutovaxID incorporates several features that lead to enhanced automation of this device. Most notably, the system incorporates real time CO2 measurement as a means of monitoring and controlling lactic acid concentration in the culture. Based on a user-defined lactate setpoint, media delivery rates are automatically adjusted as the cell population expands. This provides on optimal feed strategy without need for expertise or waste of expensive media. The instrument provides many of the control and process optimization features of bioreactors that are much larger, with the additional advantages of versatility, small footprint, and ease of use.

Biovest's National Cell Culture Center routinely uses the AutovaxID for its monoclonal antibody production services. Antibodies have been produced from client-derived cell lines that include mouse and rat hybridomas, human heterohybridomas, and transfected CHO lines. Production levels vary considerably, depending on the cell-specific productivity and intended duration of each culture. Overall, quantities produced ranged from 0.5 gm to 5.6 gm in 45 days. In general, an average hybridoma that produces 15–ug/mL in T flasks can be expected to produce 1–2 grams of antibody in 30 days from the AutovaxID. More importantly, these cultures required approximately 75% less labor than that typically required for conventional hollow fiber bioreactor production instrumentation (10–15 hours per month, as opposed to 40–45 hours per month). As a result, technician time was more available for additional projects, which significantly increased overall productivity of the laboratory.


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