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

LOOKING UNDER THE HOOD


Figure 2
The AutovaxID instrument consists of two components: the control unit and an enclosed, disposable bioreactor (cultureware). The disposable component is completely enclosed in a plexiglass housing that slides into, and snaps in place within the instrument. The series of photographs in Figure 2 demonstrates the ease of use of the AutovaxID. Initially, a completely enclosed, disposable culture module is removed from its packaging (middle left) and placed in the control unit (upper left). Next, the culture parameters are programmed into the instrument (upper right), followed by bar code scan (middle right) for materials tracking and data capture. Following this, cells are introduced into the bioreactor and the automated culture process is initiated (lower right). For the duration of the culture, clarified supernatant is continuously collected and stored in the refrigeration compartment of the AutovaxID (lower middle) until the run is terminated, or product is ready for further processing. With conventional hollow fiber instruments, technicians must first prepare the cultureware for installation into the instrument. This may include loading peristaltic pumps, aseptically inserting an autoclaved pH probe, and manually opening and closing clamps to facilitate a preinoculation fill and flush procedure. The entire preparative process may take several hours and is prone to mistake by an inexperienced technician. All these manual operations have been eliminated with the AutovaxID. Technicians need only snap the cultureware into the device and connect a media feed source. Following an automated fill and flush procedure, inoculation and secondary pH calibration, the instrument's process control then allows for unattended operation for the duration of the culture.

The disposable cultureware for the AutovaxID contains all disposable fluid or product-contact components, including the bioreactor and associated tubing, pH probe, cycling and harvest bags, and a gas exchange cartridge to oxygenate and provide feedback control of pH in these densely packed cultures. Note that although the AutovaxID is described as a "closed" system, users must still introduce cells and change media bags, which is normal for any cell culture device.

The AutovaxID control unit contains a built-in computer, touch screen display, and built-in solid-state refrigerator. The entire system can be monitored and controlled remotely via a web browser. The software was designed to maintain process parameter setpoints for pH, lactic acid, and temperature, and also to monitor pump speeds and calculate media volumes. When media reach a critical low point, for example less than five liters, the technician is alerted to replace or add a new container.

Biomanufacturing has benefited for 20 years from hollow fiber bioreactors, whose principal advantages are their disposability and ability to support a large cell population within a very small space. Hollow fiber bioreactor devices are also continuous, densely-packed cultures that facilitate product harvest at high concentrations. This, combined with online product filtration in the AutovaxID, greatly facilitates or eliminates the first step in the product purification process. In hollow fiber bioreactor systems, it is common to harvest protein continuously at concentrations of several milligrams per milliliter, as opposed to micrograms per milliliter in conventional batch processes. As an added benefit, hollow fiber bioreactors conserve costly, high molecular weight growth factors or serum-based additives by retaining these expensive reagents on the same side of the membrane as the cells.

The AutovaxID was specifically designed for use in multiproduct facilities that must manufacture large numbers of patient-specific, cell-based therapies simultaneously and in a relatively compact space. In designing the AutovaxID to include such features as product segregation capability, automation, and software security we believe that we have addressed the key regulatory requirements relating to production of personalized biologics by the instrument.

THE FUTURE OF PATIENT-DERIVED PERSONALIZED THERAPIES

The challenges for developing a bioreactor that addresses the manufacturing needs of personalized therapeutics are daunting. Any application involving the expansion of specialty or patient-specific cells will be extremely labor-intensive and expensive using traditional cell culture methods. As medical science struggles with the regulatory issues and labor burden of expanding cells in culture for personalized treatments, we believe that the AutovaxID platform technology is the only way to cost effectively manufacture and market these products.

AutovaxID has shown its value and versatility for producing patient-specific secreted proteins for therapeutic use, at a cost that makes potentially life-saving therapies accessible to patients with many serious illnesses. While we expect to continue to serve this important area of personalized medicine, we also expect that many new and promising treatments will arise from cell-based therapies. Biovest is currently exploring ways to optimize the AutovaxID for applications which involve recovery of whole cells grown in the AutovaxID for therapeutic use. At present, our challenge is to develop a process that allows for cost-effective growth and efficient recovery of unique or specialized cell types, including stem cells.

Biovest and its parent company, Accentia Biopharmaceuticals, are committed to the continued development and improvement of the AutovaxID instrument for the production of therapeutic materials. Both companies believe that within the next several years it will become a key enabling technology for the emerging field of cell and cell-derived therapeutics.

Mark Hirschel, PhD, is chief scientific officer at Biovest International, Inc., Minneapolis, MN, 800.325.111 ext.206,


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