In the thriving life sciences industry in Massachusetts, what is the opportunity that has been left at the table?
It may be in biomanufacturing, with a strong emphasis on the manufacturing of biologic-based clinical drugs.
Investigational drugs are manufactured so that clinical trials can take place. Clinical trials emerge from the laboratory into human trials that begin at Phase I, where product safety is determined in using the drug on twenty or more healthy volunteers, through Phase III, in which thousands of patients may be treated with the drug to determine its efficacy and proper dosing. These trials ultimately inform regulatory authorities such as the Food and Drug Administration (FDA) whether or not the drug should be approved for commercial use.
Companies developing investigational drugs must make a choice fairly early in the five- to 10-year clinical development process. Do we develop our own clinical manufacturing capacity, or do we hire a contract manufacturing organization (CMO)? With more than 1,200 investigational drugs in development in Massachusetts, 40 percent of which are biologic-based drugs, a relatively small number of this clinical production is taking place in Massachusetts. Herein lies the opportunity.
‘The People Who Know Biomanufacturing Are Here’
A natural assumption may be that this type of manufacturing simply can’t take place in the region. In fact, Massachusetts, New Hampshire and Rhode Island combined possess the greatest capacity in the world for the production of biologic drugs using the mammalian cell culture method (now the dominant manufacturing standard for new biologic-based drugs). Amgen in West Greenwich, Lonza in Portsmouth, and Bristol-Myers Squibb in Devens have facilities that are among the top ten largest biomanufacturing facilities in the world. Other biologic manufacturing facilities are operated in Massachusetts by Pfizer, Genzyme, Shire and AbbVie, among others.
These facilities aren’t here because of our wonderful weather or low costs. They are here because of the substantial expertise around biologics research, development and manufacturing that has developed over the past 30 years. The expertise exists not only in the manufacture of these products, but also in design of the facilities themselves. The Boston chapter of the International Society of Pharmaceutical Engineers (ISPE), with over 1,700 members, is by far the largest chapter in the world. In the recently released “IMPACT 2020,” MassBio’s strategic plan to advance the state’s leadership in the life sciences, Genzyme’s Bill Aitchison said, “We come to Boston because the people that know biomanufacturing are here. They don’t exist in Singapore or India. There are few places in the world where you find the right people for biomanufacturing.”
All of this know-how, however, is being primarily directed to the production of commercial products. With the exception of Lonza, which is a CMO, these large biologics companies are either manufacturing their own approved drugs for the commercial market, or their own products for clinical trials. They are joined by smaller drug development companies that have developed small clinical production facilities in-house.
A great number of drug development companies, therefore, must look outside the area for clinical production capacity. In an industry that is more virtual and outsourced than ever, that these companies must look beyond our immediate borders for manufacturing capabilities is regrettable.
In the recent report “Super Cluster, Extending the Commonwealth’s Global Leadership in Biomanufacturing,” the authors call for a private-public partnership to develop contract clinical operations. Refocusing state incentive programs may be an effective means of supporting the growth of clinical production capacity. MassDevelopment’s Emerging Technology Fund, a loan fund for manufacturing in emerging industries, is not currently allowed to fund life science companies. The Massachusetts Life Sciences Center, which can fund life science companies, has no loan program available for manufacturers or those who aspire to transition, perhaps, from contract research to contract manufacturing.
The industry itself can be the greatest force in growing biomanufacturing locally. As MassBio’s report further states, “new therapies … being developed in Massachusetts will all require unique manufacturing solutions closely integrated with R&D operations.” If the courtship between research and manufacturing can be incented to become a marriage, it may prove a powerful relationship for the region’s economy.
Peter Abair is director of economic development and global affairs at the Massachusetts Biotechnology Council (MassBio).
