To gain perspectives on these and other trends, BioPlan Associates asked the 425 global subject matter experts and senior
participants on its Biotechnology Industry Council to evaluate the current trends in bioprocessing and biopharmaceuticals.
The more than 100 trends identified were categorized as follows:
- 24% downstream process improvements
- 22% single-use implementation and improvements
- 24% analytical methods
- 30% others: product platforms, cost reductions, materials sourcing, supply chain regulatory compliance, biosimilars, etc.
This relatively evenly distributed breakout suggests that the industry expects advancements in virtually all areas (see Sidebar).
DEMAND FOR A BETTER TECHNOLOGY EVALUATION PROCESS
Rapid and cost-effective evaluation of new technologies is crucial to the industry achieving this expected progress. Evaluating
new technologies in the regulated pharmaceutical environment can be slow and costly to both innovators and to the end-users
doing the beta or evaluation testing. To reduce these challenges, BioPlan Associates has implemented a New Technology Evaluation
Program (NTEP) to help kick-start innovation in bio/pharmaceutical manufacturing. The program helps ensure that the best technologies
are eventually adopted by industry, even when their originators are small or resource constrained.
The program benefits suppliers by providing high-value evaluations, rapidly getting new products into the right hands for
testing, and coordinating multi-site testing with integrated, compiled data and reporting. The program benefits those testing
new products by giving them access to the most promising and cutting edge technologies while eliminating the need to deal
with multiple contacts from multiple suppliers. This process can provide available data from other commercial evaluations
as an unbiased resource, and can rapidly integrate, publish, and disseminate these findings to industry.
The key trends in this industry are being driven by the need for new efficiencies, greater quality, and cost reductions in
manufacturing processes. To remain competitive, especially as biosimilars and biobetters evolve, better ways of evaluating
new technologies are needed that cut down on time to market and streamline the overall testing process. There is an increasing
demand in the industry today for improved productivity, cost reductions, and higher quality, as companies continue to struggle
to do more with fewer resources. Many are relying on suppliers' innovations to advance production processes for current biologics,
emerging biosimilars products, and for the production of biologics in emerging markets using flexible processes. The industry's
suppliers/innovators continue to demonstrate their commitment by investing in development of new technologies. Concurrently,
end-users' demand for improved productivity continues to fund these improvements. More streamlined new product and technology
evaluation programs, coordinating trial users throughout the industry, promise to facilitate innovation and its dissemination.
Eric S. Langer is president and managing partner at BioPlan Associates, Inc.,