Evaluating Impact of Personalized Medicines on Pharmaceutical Manufacturing

Interphex2007, New York, NY (Apr. 26)-As focus shifts away from “one-size-fits-all” medicines and begins centering on personalized medicines, many companies begin to wonder how they can manufacture such drugs economically. Mark Hirschel, chief scientific officer of BioVest International (Worcester, MA, www.biovest.com), addressed that issue in his presentation, “A Bioreactor System Designed for Production of Personalized Therapeutics,” at Interphex on Thursday.

According to Hirschel, some of the challenges facing personalized medicines include:

• Manufacturing: Assessing what capacity is available for the production of personalized medications, and how to tailor current technology to increase capacity?

• Regulatory

• Ethical: how does one explain to a patient that what worked for someone else probably won’t work for them?

• Economic: personalized medicines do not follow the blockbuster model and are very expensive to produce, which raises the question of who should pay?

To illustrate the resolution of these issues, Hirschel explained how BioVest developed an autologous vaccine for non-Hodgkin’s lymphoma. Autologous vaccines are based on a particular patient’s tissues, which are collected, in some cases treated, and then reintroduced into the body. Autologous treatments in current use include skin grafts and bone-marrow transplants.

BioVest was faced with the difficulty of manufacturing a personalized medicine. The process is labor intensive and needs to be modified for each patient, and it is very difficult to design and operate a facility that processes thousands of patient-specific cells. The company settled on manufacturing the vaccine using mammalian cell cultures in a hollow fiber bioreactor (HFBRx). HFBRx technology, which very recently gained acceptance in the therapeutic arena, is disposable, easy to scale, and very small.  It automates the process of producing cells, thus cutting down on labor and minimizing technician interaction, and it also is a closed system.

BioVest created its own HFBRx, “AutovaxID,” to produce the non-Hodgkin’s lymphoma vaccine.  The machine is small enough to fit on a tabletop, thus eliminating the need for tissue-culture incubators. It is a closed system with secure access and online data collection.  As the machines are small, the cost of a facility to house them, according to Hirschel, is $35–40 million, compared with $66–73 million for a classical manufacturing facility.

Hirschel closed by looking to the future.  He believes there will be a move toward applying technology to autologous or other cellular therapies and toward further automating the process to ensure reproducibility.