BioPharm: Given the diversity of forms for vaccines (i.e., VLPs, viruses, protein antigens), what strategies do you have for
ensuring your facility can meet the demands of such varied production requirements?
Chacón: We can work with a variety of systems with relative ease, and this has to do with how our GMP services were started. We
were in the business of providing preclinical services for around 17 or 18 years. We developed a number of skills and capabilities
at smaller scale and with different reagent grades to produce recombinant proteins, VLPs, and different viral vectors including
adenovirus, and lentivirus. We had to build those capabilities, and add the analytics required to oversee a process and characterize
the final product. When we added GMP manufacturing, it was a very logical extension of those preclinical services. We went
ahead and built in the versatility to support a variety of services.
Technology changes, and we need to embrace that. The challenge is on us, to look to the future and anticipate those changes
to remain at the cutting edge and be of greatest help and assistance to our clients. We need to be mindful of how the marketplace
changes, because to be successful at growing a company you need to be sure that your offerings are in tune with such demands.
Today, the large pharmaceutical companies that used to do everything on their own send out many projects including vaccine
production services. In fact, it goes across the whole panorama of needs, from preclinical targets, to vaccine candidates,
to GMP manufacturing for clinical trials. By keeping a keen eye as to where those demands are coming from, what type of technologies
the marketplace is asking us to provide, we need to be swift and nimble and move with the times.
On the manufacturing side, I think the adoption of new technology is critical. The past 10 years or so, certainly in mammalian
and insect cell expression, we've seen a shift to the use of single-use disposables. With single-use disposables you can do
mammalian or insect runs up to 2000 L in a single run, although we only go up to 500 L. Disposables cut down on cost, because
cleaning protocols are extremely reduced or not necessary for many aspects of the manufacturing process.