As a new era of biotechnology medicines is emerging, it’s spurring an unexpected rethink on the industry’s approach to manufacturing. Alison Moore, PhD, presently presides over Amgen’s process development group, which manages the critical process that takes a molecule from R&D and optimizes it to a state that makes it suitable for manufacturing. She shares her perspectives on the past, present, and future of the biotechnology industry and how innovation in process development is helping create a new world of therapeutic possibilities.
Do you think the line is blurring between biotechnology and traditional pharmaceutical medicines?
Moore: Already we have witnessed the emergence of hybrid medicines that combine a biologic with a synthetic (or “small molecule”) drug. For example, a single medicine can couple an antibody with a poisonous synthetic chemical. The antibody can be designed to target cancer cells and to deliver its toxic cargo to thwart tumor growth. I think there will always be important opportunities for purely biologic or purely chemical entities, but I believe we’ll see even more blurring between them, giving rise to a variety of potent therapeutic configurations.
Can you explain Amgen’s “biology first” approach?
Moore: Amgen’s “biology first” approach involves understanding as much as possible about a disease and the tractable molecular targets for treating that disease. Then, armed with that knowledge and unbound by any platform or molecular family, we decide how to design and develop the best therapeutic tool to interfere with those targets. We believe that this agnostic approach will lead to greater success over the long term.
Do you have people with more varied expertise working on these more sophisticated biotechnology medicines?
Moore: There is a body of research devoted to the success of putting disparate disciplines together and how it can be helpful in trying to get past technical barriers. That’s what we did within our process development organization, which is unusual for our industry. We pulled chemists and biologists into a single group. Having these teams, who would normally work exclusively on small or large molecules respectively, work side-by-side is helping us to overcome unique process development hurdles.
What do you see as the next wave in process development and manufacturing?
Moore: We are moving away from one of the mainstays of biotech manufacturing — massive facilities with large, bulky stainless steel bioreactors and miles of piping. Although these plants have served us well, they are inflexible and expensive to maintain. Amgen is now investing in more flexible infrastructure. Imagine a large ballroom — it’s empty but contains the utilities to support biotech manufacturing depending on demand. By bringing in disposable and modular equipment, we can easily adapt to whatever production paradigm we need.
You’ve spent practically your entire career working in biotechnology. What excites you most about the field?
Moore: I trained as a cell biologist when the biotechnology industry was just emerging. Even now, I’m still amazed by what we can achieve by melding cell biology and recombinant DNA technology. This combination — the bedrock of biotech — has given us some very powerful medicines. That notion still motivates me, every day. The continued opportunity, the evolution of what we can do with our science, and the outcomes we can deliver — it’s a very fulfilling cycle. I feel so privileged to have found this career.