The biopharmaceutical manufacturing industry’s ongoing drive for improved productivity and efficiency has led to the emergence of a number of important trends over the last year. Read on to learn more about what forces are shaping and driving biopharma manufacturing today.
According to biotechnology marketing research and publishing firm BioPlan Associates’ most recent annual survey of biopharmaceutical manufacturers, continuous bioprocessing (CBP) is the second-most important operational area on which the industry needs to focus its efforts (second only to manufacturing productivity and efficiency, which is consistently the top choice in BioPlan’s annual survey). In fact, the number of survey respondents who cited CBP as the top industry trend this year was more than double that of last year.
Already a commonly used and successful model in many other industries, continuous processing relies on an assembly-line setup rather than on the episodic manufacturing process that is currently the norm in biopharma production. With CBP, instead of one process step at a time being completed before materials move on to the next step, materials flow continuously from one process to the next at lower levels of productivity, but over longer periods of time.
CBP is a good manufacturing fit for areas like recombinant protein and antibody manufacturing, gene therapy, and many other newly developing product classes. However, in spite of CBP’s many benefits—including greater cost efficiency, increased productivity, higher quality, and better flexibility—less than 10% of commercial biopharmaceuticals are currently manufactured using CBP processes.
As their name suggests, single-use applications, also called “disposable” applications, are biopharmaceutical manufacturing products and devices that are intended for one-time use. The past decade has seen significant increases in the quality and range of available single-use products. In the early 2000s, for example, the first disposable bag to store and transport buffers and media was introduced. Today, facilities can choose from a variety of single-use products for everything from everyday lab use to systems for operations and process platforms. Disposable bags and connectors, probes and sensors, bioreactors, and purification products are among the most commonly used products.
Single-use applications are growing in popularity in the industry thanks to their many benefits, which include the virtual elimination of any risk of batch cross contamination; decreased floor-space requirement due to a smaller spatial footprint; significant overhead cost savings in labor and materials; and greater design flexibility and expedited delivery. In fact, single-use devices have made such inroads into biopharma manufacturing that more than 60% of respondents to the BioPlan survey agreed that within the next five years, the industry is likely to see a 100% single-use facility in operation.
Now that the FDA has approved a second biosimilar product for use in the United States, biosimilar development and manufacturing is expected to move into high gear. Biosimilars are biological products that are similar—that is, that do not differ in any clinically meaningful way in terms of safety and effectiveness—to an already-approved biologic treatment. In many ways, biologics and biosimilars have the same relationship as brand-name drugs and their generic equivalents.
As has been the case with the mainstream drug market, industry experts predict that biosimilars will soon outnumber their biologic reference products, mainly due to the fact that, just like generics, biosimilars are much less expensive. Their overall market dominance, however, will be dependent on the industry’s ability to successfully implement efficient bioprocessing and produce follow-on products in a cost-effective manner.
As bioprocessing becomes more flexible, increasing numbers of bioprocessing technology vendors are turning their attention to the development of modular approaches, and fully modular facilities may not be far away. Soon, companies will have the ability to assemble systems completely composed of off-the-shelf modules or customized modules ready for full integration with other modules; and multiproduct, hybrid, and even completely modular facilities will quickly become the new standard.
While overall growth of outsourcing within the biopharmaceutical manufacturing industry has been slower over the last year than originally anticipated, the outsourcing that is occurring is becoming more strategic, more targeted, and better executed. Furthermore, more and more companies are doing at least some outsourcing: according to last year’s BioPlan survey, only 35.3% of respondents reported that they did not outsource any of their bioprocessing activities whatsoever during the previous year. At present, the majority of outsourced activities fall into the categories of testing services and production operations. Increases have been reported in the proportion of companies outsourcing such activities as product characterization testing, cell line stability testing, host cell protein analysis testing, and analytical testing of other bioassays.