By Eric Langer, president and managing partner, BioPlan Associates, Inc.
Biopharmaceutical manufacturers are demanding more from their vendors’ R&D teams. This year, we found in our annual study that end users are more aggressively asking their suppliers for solutions to their biomanufacturing problems. In our 8th Annual Report and Survey of Biomanufacturers, we asked end users to indicate the top five new product and service areas they want their suppliers to develop. Our objective was to identify “problems in need of solutions.” We then compared this to the areas that vendors are actively investing in with R&D resources.
The largest portion of end users used one of their five “wish list” choices to cite better disposable purification products (37.9%), followed by disposable probes, sensors, etc. (37%) and disposable products such as bags and connectors (36.5%). In services areas, “process development downstream” made the top again in 2011. Stainless equipment remains at the bottom of the list, with only 6% of vendors indicating they’d like new products developed in this area.
Additional areas of interest among buyers, both this year and last, included:
- online monitoring and control
- improved quality and consistency of materials
- energy efficiency
- quality control and consistency
- reliability/robustness of analytical equipment.
“Disposable products: purification” was not unexpected and is due to improved upstream performance, such as with better cell lines and expression systems. In contrast, downstream purification processes have changed little and are increasingly the major limiting factor in commercial-scale biopharmaceutical manufacture.
On The Vendor Side
Vendors recognize the gaps in what is needed and are starting to invest heavily into the technical solutions that biomanufacturers demand. In addition to surveying biopharmaceutical manufacturers, we also surveyed 186 suppliers to the industry on issues associated with business growth, budgets, new product development, training, and what biomanufacturers expect from their suppliers.
From our study, the largest number of vendors to this industry indicated they are working on new disposable, single-use bioreactors, bags, and consumables. The same percentage noted that “bioprocess development services” are the next New Product Development area (indicated by 40.5% of vendors). Disposable chromatography is the third largest area, with 34.2%.
Other new product development activities by vendors:
- services, technology transfer
- services, process validation
- continuous processing
- upstream process — transfection in synthetic media
- single-use connection technologies
- sterilizing filtration validation services, filtration process training
- open facility designs
- services, extractables & leachables testing.
Given the increasing use of disposable products in biomanufacturing, it is not surprising that the development of new disposable products is among the top R&D products/services now being developed by vendors.
This year’s study indicates that, in general, the biggest problems being faced by the industry are also being addressed by suppliers. Success in these areas will help ensure individual vendors maintain a technical advantage. Vendors face a dilemma, however; they need to discuss their R&D efforts with their customers, yet not overpromise. In fact, biomanufacturers report in the study that one of their biggest problems with vendors is that they make promises they cannot keep. Managing customer expectations is particularly important. Communication with the customer stakeholders is critical and is recognized by vendors.
Other results in the study reported by vendors indicate a sense of optimism about the market. Revenues and budgets have increased, along with the demand for new biopharmaceutical approvals and improvements in the economy. This has led to budget increases and focus on new product/service development in response to the acceptance of innovative products such as single-use disposable products.