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A greater focus on efficiency is leading biopharma suppliers to invest more heavily in bioprocessing optimization.

(Photo credit: Abd allah Foteih)Vendors to the biopharmaceutical manufacturing industry have been enjoying strong and consistent sales growth rates over the past decade. In fact, according to our latest industry study, BioPlan Associates’ 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production [1], suppliers last year averaged almost a 15 percent increase in sales to this industry.

Buoyed by demand, vendors to the biopharmaceutical manufacturing industry have hiked their budgets in recent years across several areas. One of particular note is spending on basic R&D for new product development.

This year, vendors predict a five percent average for spending on new product development in basic R&D technologies, up from 4.2 percent last year and 3.5 percent in 2013. Enthusiasm for new product development has increased almost every year since 2009, when budgets were forecast to remain flat. This is now one of the foremost areas of budget growth for vendors.

So what new products and services are suppliers investing in to meet industry demands? Analyzing the trends in vendors’ offerings offers interesting insights into the state of the biomanufacturing industry itself.

Optimization Tops the List

We asked the 164 supplier respondents to our survey to identify the top new technologies or new product development areas their company is working on in biomanufacturing. Of the 40+ areas that we measured, we discovered that by far the top area of focus for suppliers is bioprocess development/optimization services/bioprocess modeling. This is a leading area of focus for roughly 4 in 10 respondents, a figure broadly consistent with years past.

It’s not surprising to see bioprocess development and optimization services top the list of development efforts among suppliers, as the industry remains heavily focused itself on these efforts.

Separately, we surveyed 237 qualified individuals at biopharmaceutical manufacturing organizations and contract manufacturing organizations (CMOs) on a number of topics. When we asked their views of the single most important biomanufacturing trend or operational area the industry must focus its efforts on, the largest proportion cited manufacturing productivity and efficiency. This beat out several other areas such as biosimilars, single-use systems and continuous bioprocessing.

The implications for suppliers are clear: as biomanufacturers endeavor to push innovation forward and remain competitive as cost pressures increase, they will continue to demand better ways to cut time-to-market and streamline overall bioprocessing.

How Are Biomanufacturers Creating Improvements?

With the industry’s focus squarely on boosting productivity and efficiency, it’s worth looking at the various factors biomanufacturers have been implementing in order to improve performance at their facilities.  With reference to performance improvements over the past year, biomanufacturers were most likely to ascribe “significant” or “some” improvements to:

  • Use of disposable/single use devices (68.6 percent)
  • Overall better control of process (67.5 percent)
  • Better analytical testing and product release services (66.3 percent)
  • Better process development (63.9 percent)

While CMOs were most enthusiastic about the benefits of disposable devices, biotherapeutic developers were most apt to say that better process control resulted in performance improvements. As such, suppliers’ focus on bioprocessing optimization efforts seems well placed. The above list also shows that suppliers’ growing interest in cell line optimization is in response to industry demand.

Of course, there’s no escaping the influence of single-use applications, which have been credited with improved efficiencies and performance, particularly for CMOs. Indeed, when we evaluated the industry’s demands for new products (and a few services) from vendors, several disposable applications dotted the top third of the list, including:

  • Disposable purification products (35.7 percent cited this as a top-five area)
  • Disposable probes and sensors (34.5 percent)
  • Disposable bioreactors (31.6 percent)
  • Disposable products, bags and connectors (29.2 percent)

Suppliers appear well attuned to those desires, too. Indeed, among their development efforts, disposable applications occupied the next four positions directly following the aforementioned bioprocess optimization services. Specifically, vendors are also investing in disposable/single-use bioreactor bags and consumables, and other disposable technology.

Increasing Bioprocessing Efficiency

The strategic importance of biopharmaceutical manufacturing and manufacturing capacity are increasing, and understanding the markets for bioprocessing equipment, technologies and services is becoming ever more important to those in the biopharmaceutical industry. Planning and decision-making concerning the manufacture of biopharmaceuticals is becoming more complex as companies continue to expand, implement new innovations and look to cut costs.

Manufacturers are also tasked with navigating a growing array of choices and bioprocessing options, varying from new and improved cell lines, single-use equipment, alternative chromatography methods, and even outsourcing to increasingly sophisticated CMOs. Increasingly, companies must make difficult and costly strategic decisions about commercial manufacturing earlier in product development.

Within this context, future trends identified in our report that suppliers should keep their eyes on include:

  • More adoption of single-use systems for commercial manufacture
  • More continuous processing, including perfusion
  • More high-tech expression systems and other genetic engineering advances
  • More automation, monitoring and process control
  • More efficient bioprocessing

The good news is that – at least as measured in titers and yields – bioprocessing efficiency is increasing. Research studies we have undertaken indicate that while upstream titers for commercial mammalian, including mAb, manufacturing started in the 1980s at less than 0.5 g/L, they now average ≥2.5 g/L.

That estimate includes older legacy products that are still being manufactured at relatively lower titers as well as a growing number of newer products that are being manufactured at upstream titers of up to 7g/L. We estimate that commercial-scale manufacturing titers are generally increasing at about an 18 percent rate per annum.

Downstream processing can’t boast the same improvements. This is the primary reason for industry and supplier focus on downstream purification products. Through our research we have determined that current average DSP yield at commercial scales averages 70 percent, below the 75 percent figure that has been widely adopted by the industry. So while DSP yield has at best doubled, upstream titers have increased recently by orders of magnitude.

The point is that while implementation of new technologies and services can sometimes be painfully slow, there are encouraging signs that biomanufacturers are achieving productivity gains. And as results from our report demonstrate, suppliers are, in many ways, responding to demands from the industry.

The next step in the bioprocessing evolution looks like it will be module bioprocessing systems, or at least compartmentalizing and sealing unit process equipment. While this trend is still in its infancy, suppliers are already taking note. In fact, the development of modular construction for biofacilities is already in their top half of new product development areas. Stay tuned for more.

References:

  1. 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, BioPlan Associates, Inc. Rockville, MD., April 2015,

Survey Methodology: The 2015 Twelfth Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production yields a composite view and trend analysis from 237 responsible individuals at biopharmaceutical manufacturers and contract manufacturing organizations (CMOs) in 28 countries. The methodology also included 164 direct suppliers of materials, services and equipment to this industry. The quantitative trend analysis provides details and comparisons of production by biotherapeutic developers and CMOs. It also evaluates trends over time, and assesses differences in the world's major markets.

This article can also be found in the October 2015 edition.

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