Amgen & Genzyme Talk Top Trends At BPI 2015
By Trisha Gladd, Editor, Life Science Connect
Biopharmaceutical experts from around the globe gathered in Boston this week at the BioProcess International Conference & Exhibition to discuss the trends and challenges affecting today’s industry. The conference covered a variety of issues spanning across five tracks: Cell Culture, Recovery & Purification, Drug Product Manufacturing & Fill-Finish Processing, Manufacturing Strategy, and Analytical, Formulation, and Quality. However, among all the presentations given at the conference, the ones that clearly had the most impact on attendees were those given by Wednesday morning’s keynotes speakers.
The first to take the stage was Kimball Hall, VP of manufacturing for Amgen in Singapore. Dr. Hall gave the audience an inside look at the facility that Amgen (along with much of the industry) is calling a “next-generation facility.” This is because of its combined use of single-use bioreactors, disposable plastic containers, continuous purification processing, and real-time analysis. Also, it’s footprint of only 120,000 square feet is less than half of the size of the traditional 750,000 square foot conventional facility.
When looking at the industry in the past, she described one that consisted of high-margin products and limited competition. It was all about creating capacity and capability, which is much different from today’s focus. “Biomanufacturing is becoming commoditized and now cost, speed, and flexibility really are the differentiators that are important to us,” explained Dr. Hall. “In addition, the capabilities on the drug product side also have to be differentiating and so that evolving world is what’s causing us to be more competitive as we look at our portfolios and production strategies.”
The 6 x 2000 liter facility took only 15 months to build. Dr. Hall says three months of this was dedicated to piling, due solely to the location in Singapore. Without this added time, a facility like this could be built in a quarter of the time it takes to build a conventional facility. She described this as the biggest advantage. “In a conventional facility, you have to start thinking about your capacity really early, around phase 2 or 3, and determine if you have the existing capacity to meet the needs of the product. You do this because it takes four years to build a facility,” she noted. “[With a facility like the one in Singapore] You can wait until you’re licensed to have to understand what your uptake is going to be over time before you have to invest in new capacity.” In discussions after her keynote, many felt this was the most powerful statement in her presentation.
She also provided an update on the facility, which is currently scheduled to wrap up PPQ runs in less than two weeks. Completion and licensing is expected around 2017. In addition to the reduction in time, Dr. Hall added that its cost was one-third of the operating expense of a traditional facility and one-quarter of the capital costs.
Next up was Konstantin Konstantinov, VP of technology development at Genzyme, who offered a very detailed presentation on Genzyme’s (now Sanofi’s) work with continuous processing and what needs to be developed in order to have a truly continuous process. One question he says he is often asked when it comes to continuous processing is when to do it and what kind of product should be selected for it. He says this is a challenging question without a single, clear answer for all organizations. “If you have to integrate a completely new product from your pipeline with a completely new technology, this is high risk because there is very little tolerance in the organization to delay a launch of a new product,” he explained. “So, in many cases, it’s reasonable to consider that new technologies of new platforms are best implemented during the development of second-generation products. In this case, you have a little bit more flexibility to play around and there’s a willingness from the organization to take a risk.” Whether or not a company succeeds with continuous processing, he explains, needs to be driven from the highest level of an organization.
The dominant design that Genzyme believes current innovation is going to lead to is a universal platform that almost any kind of therapeutic protein can be produced. “We’d like to see [the dominant design for continuous manufacturing] it as starting from the media throughout the entire process to drug substance and perhaps even beyond to incorporate the drug product in a continuous line. However, this is not going to be enough, because in order for a process like this to exist and function properly, it’s very important that it’s equipped with an integrated control system, which is often underestimated,” he noted.
Longer term, Dr. Konstantinov believes there is potential for continuous processing to be a way to commoditize biomanufacturing. “Comoditization and biomanufacturing, at this point, are totally incompatible because of high prices,” he says. “This could allow them to be compatible.” He finished with a quote from Dr. James Utterback, professor of management and innovation and professor of engineering systems at Massachusetts Institute of Technology, who he credits with coining the dominant design. When it comes to the future of continuous processing, “the central issue is not when and how. We believe it will happen. Organizations should be very focused because only a total commitment will win the day.”