The current situation in biopharma is exciting, with new technologies, biosimilars, cellular and gene therapies, and opportunities in emerging markets. And these innovative platforms are going to continue to need improved manufacturing technologies in the future.
Although change is constant, it generally comes very slowly to the highly regulated biopharma industry. Bringing a biologic to market can be a decades-long process, so tracking trends needs to take a long view. Based on decades of analysis, and findings from our 13th Annual Report of Biopharmaceutical Manufacturing, this article will outline some of the key factors affecting the industry today.
The desire for innovation in the biopharmaceutical manufacturing industry continues unabated, as companies ramp up their spending on new technologies to improve efficiencies in both upstream and downstream bioprocessing. And while innovation in this industry can be slow to come, the past decade has seen the emergence of several new innovative trends, ranging from the proliferation of single-use devices to growing demand for continuous bioprocessing and modular facilities, according to BioPlan Associates’ 13th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production.
One of the most important trends to emerge from preliminary results of this year’s survey is the increased attention paid to continuous bioprocessing. Integrated, broad up- and downstream technologies remain to be developed and commercialized. Despite this lack of viable options, there is a groundswell of enthusiasm for the concept.
Trends in biomanufacturing follow a slow cycle, partly due to the regulated nature of the industry and the substantial costs and risks that introducing a change in the process can bring. But that ignores the benefits that changes in bioprocessing over the past 10 years have brought, from better expression systems, to new modular and flexible facilities, sensors, and control systems for downstream operations.
The data from BioPlan Associates’ 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production speaks to the industry’s ongoing desires for standardization in single-use devices. As usage of these disposable devices increases, the gap between the importance of standardization and end-users’ satisfaction with their supplier’s standardization efforts has steadily been worsening.
Disposable products continue to be a hot topic in biomanufacturing, as they increasingly penetrate clinical- and commercial-stage manufacturing and are sought after for their process efficiencies. In fact, when we asked the 450 global subject matter experts and senior participants on our Biotechnology Industry Council™ to identify the critical trends in bioprocessing for 2013, 22% cited aspects associated with implementation of single-use system integration. These ranked narrowly behind need for downstream processing optimization, and analytical methods development (each at 24%). By Eric Langer, president and managing partner, BioPlan Associates, Inc.
Single-use systems are rapidly becoming mainstream in the biopharmaceutical industry, even in commercial manufacturing. Results from our 9th Annual Report and Survey of Biopharmaceutical Manufacturers indicate that budgets for single-use components are also on the rise, meaning this trend is likely to continue. By Eric Langer, President and Managing Partner, BioPlan Associates, Inc.
Single-use innovation continues to be a hot topic, according to results from our 9th Annual Report and Survey of Biopharmaceutical Manufacturers. In fact, disposable products account for three of the top five new product development areas of interest this year among the 302 biomanufacturers we surveyed (the study evaluated 21 different new product areas). By Eric Langer, President and Managing Partner, BioPlan Associates, Inc.
Downstream operations continue to create challenging bottlenecks and capacity problems. To identify what the industry is doing to address these bottlenecks, we asked 302 biopharmaceutical manufacturers in our 9th Annual Report and Survey of Biopharmaceutical Manufacturers about the specific areas their facility has actually implemented to improve their downstream purification (DSP) operations. By Eric Langer, president and managing partner, BioPlan Associates, Inc.