Biopharmaceuticals (defined as recombinant proteins, monoclonal antibodies and nucleic acid-based products) are one of the fastest growing sectors within the pharmaceutical industry. In recent years, approximately one out of every four drugs introduced the market has been biopharmaceutical. The U.S. biopharmaceutical industry is leading global medical innovation with more than 300 new medicines approved by the U.S. FDA in the last decade. More than $51B in biopharmceutical R&D were invested in 2013. Of 5,000 new medicines currently in R&D around the world, 3,500 of those are being studied in the U.S. More than 810,000 people work in the biopharmaceutical industry in the U.S., and nearly 3.4 million people across the economy work in this sector (Phrma, 2013). The world market for biopharmaceuticals is now approximately $145 billion, and growing at ≥15% annually, a very healthy rate (Department of Commerce, 2014).
This steep growth is paralleled with ever-increasing demand for safe and effective drugs to treat serious afflictions such as cancer and autoimmune diseases. However, one of the challenges for the industry is that protein drugs are also contributing to the growing cost of health care. Part of this expense can be traced to costly and inefficient manufacturing. Manufacturing of biopharmaceutical products is a highly specialized and complex process because each protein molecule is unique in its characteristics and requires specifically optimized processes of production and purification. The U.S. Food and Drug Administration (FDA) has identified manufacturing of biopharmaceutical products as an area of potential improvement, and is actively seeking ways to advance innovation via the Critical Path Initiative of the Center for Drug Evaluation and Research (CDER). Even with the significant innovations achieved in recent years, FDA reports (FDA, 2011) indicate that the rapid pace of research innovation had not always translated into equally rapid advances in practical areas like manufacturing sciences. More importantly, a costly and inefficient manufacturing system can impede patient access to affordable, high-quality treatments.
With a view toward improving the quality and safety of biopharmaceuticals while helping achieve potential savings, a consortium composed of biopharmaceutical manufacturers, academic institutes, government and regulatory agencies, and equipment and material suppliers is proposed. Our rationale for the proposed consortium is multifold: (1) The dedicated organization will identify and address key issues of biopharmaceutical manufacturing and help promote understanding of the technical processes involved; (2) The proposed consortium will work to fill gaps (e.g. process efficiency, capacity, process robustness) in current the biopharmaceutical industry landscape by developing and adopting scientific innovations to improve manufacturing processes; (3) The consortium will give insight into research initiatives and how to implement administrative/regulatory guidelines; (4) The consortium will provide a platform for sustained interactions, innovation and manufacturing technology leadership (AMP 2, 2014).
The potential outcomes of this consortium are described as, but not limited to, the following: (1) a fundamental understanding of the challenges of biomanufacturing industry; (2) a roadmap for the next-generation biomanufacturing industry; (3) consortium organization and practices; and (4) a list of pre-competitive projects. Based on the track record of the existing biopharmaceutical consortium at UMass Lowell, we are well prepared to successfully implement the proposed organizational and planning activities through established partnerships and commitments from industries as well as core faculty members with research expertise in these areas
(BPQC, 2012). The team has a well-thought-out revenue and organizational plan as well as a balanced advisory board composed of the field’s top senior researchers, as well as sufficient research capabilities. Because biopharmaceutical manufacturing is a complicated process utilizing a range of knowledge and toolsets, collaborative partnership will be essential in making a sustainable nationwide and international impact.