In a just a few years, the biopharmaceutical industry has gone from questioning the feasibility of “follow-on biologics” (around the time of BPI’s first issues) to fearing them (when we published our first supplement on the topic in 2013) to the acceptance and strategizing of today. Perhaps because of its more socialized medicine, Europe led the way in biosimilar regulation and approved its first such product nearly 10 years before the first US biosimilar launch in 2015. In between came…
Although great strides have been made over the past 20 years to increase the productivity and robustness of manufacturing processes for biopharmaceuticals, the cost and complexity of their development and manufacturing remain high, especially in comparison with those of small-molecule pharmaceuticals. Process improvements are required to increase patient access while maintaining the viability of an R&D-driven biopharmaceutical industry. Facility productivity, cost of goods (CoG), and capital investment all have significant margins for improvement. Such goals can be achieved not only…
The pipeline of follow-on (biosimilar and biobetter) products in development for the US, EU, and other major markets is very healthy. It includes nearly 800 biosimilars, about three-quarters of which are presumed to be targeted for major markets, and about 500 biobetters in development. Nearly 1,200 follow-on biopharmaceutical products in the development pipeline are intended to compete with more than 100 currently marketed biopharmaceuticals. This is not just an opportunity in the Western world; biosimilars development is expanding globally. But…
The digital revolution in manufacturing began with an explosion in monitoring, analytics, and new computing capabilities. Combined with such advances as artificial intelligence (AI), automation, and robotics, they are changing our concepts of manufacturing in general — from product development and factory operations to materials supply. This evolution also connects product and process designers and leaders in manufacturing engineering. Digital manufacturing (DM) isn’t a dream or a concept on some advanced developer’s design table; it’s occurring now and will change…
Politically 2016 was surprising and dramatic here in the United Kingdom and elsewhere. Although it was not surprising for cell and gene therapies per se, the growth that we have seen in this industry has been pretty dramatic around the world as well. The industry has seen investors of all types maintaining their interest in cell and gene therapy, with a number of new deals made: e.g., Bluebird bio and Medigene signed a strategic R&D collaboration and licensing agreement, and…
Technology transfer in pharmaceutical manufacturing most often is mentioned as occurring between two organizations and involving discrete product lifecycle stages: e.g., a sponsor and a contract manufacturer and from development to manufacturing. According to the International Council on Harmonization of Technical Requirements for Pharmaceuticals for Human Use: “The goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realization. This knowledge forms the basis for…
One of the fastest growing medical markets with great potential, regenerative medicine treats chronic diseases that were once untreatable. Therapy using live cells is increasingly used to replace damaged tissue, deliver gene therapies to target tissues and organs, and stimulate self-healing along with a number of other applications. View the full article below – Login Required Reference 1 Regenerative Medicines Market: Global Opportunity Analysis and Industry Forecast, 2015–2022. Allied Market Research: Pune,Maharashtra, India: August 2016; www.alliedmarketresearch.com/regenerative-medicines-market. 2 Chartrain NA, Williams…
For a complex biopharmaceutical industry, setting out to forecast future technologies must involve considering how such technologies will be used. In the first article (1), I discussed why there was a need to develop a technology roadmap for the biopharmaceutical industry and the trends shaping its future: namely, the introduction of new product classes, the continued growth of the biopharmaceutical market, pressure to reduce costs, and uncertainty in approval and sales of new products. Herein I discuss the technology roadmap’s…
During the Biotech Week in Boston this past October, I had a chance to talk with David DiGiusto (Stanford University) about his work toward advancing bioprocessing and cell therapy development. I asked him to comment on points from his keynote presentation about how academic research groups can sustainably cycle assets into the biopharmaceutical pipeline. University research departments have long made innovative technologies available for commercial licensing. But in the excerpt below, he details ways in which such groups are further…
Biologics, primarily therapeutic antibodies and recombinant proteins, represent a growing share of the current drug market, with projected worldwide sales of about US$278 billion by 2020, partly because of their relatively high costs. Indeed, AbbVie’s therapeutic antibody Humira (adalimumab) is currently the top-selling drug in the world by sales but not even in the top 50 by the number of monthly prescriptions. Although the process for marketing generic versions of small molecules under the Hatch–Waxman Act is well understood, the…