biopharma manufacturing

Single use technologies are strong change agents in biopharma manufacturing. Disposable devices emerge once again as a top new technology of interest among the 352 surveyed biomanufacturers in BioPlan Associates, Inc.’s 2011 8th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production1.

This year, respondents indicated which single use systems (SUS) they introduced within the past 12 months. The leading technologies for new implementations are seed bioreactors. Single use bioreactor adoption was indicated by 36.2% of respondents (Figure 1). Production bioreactors garnered 32.6% of the new-use market, ranking 4th in the survey, but less than 4 percentage points off seed bioreactors’ lead. As more technically complex devices such as seed bioreactors are installed at biomanufacturing facilities, we expect to see additional market growth in common devices such as bags and tubing.

Single use bioreactors top ranking on new-adoption list

Adoption of more technically complex bioreactor technology is not a surprise. While simpler, less costly disposable devices have been gaining favor for a number of years, bioreactors have stepped up to meet accelerated production, standards compliance and competitive needs. Among others, small emerging biopharmaceutical companies and CMOs are employing these quick, efficient and cost-effective disposable bioreactor systems to speed product development and their competitive positions.

Single-use bioreactors now deliver increasing vessel size and scale along with advanced automation features. This is significant, as only relatively recently, the industry’s the most common disposable bioreactor sizes were up to 1000L. Now, some vendors offer bioreactor sizes up to 2000L that are GMP-ready and directly scalable. As their adoption advances, confidence will grow based on accumulating “track records”.

While these larger-sized disposable devices cost more, such systems may also attract users due to economies of scale. Potentially the same number of personnel could operate a bioreactor several times larger than those in place now with the possibility of lowered quality control costs because fewer batches need to be run. This strengthens applications for the vendor offerings that range from small vessels to up to the 5000L vessel bioreactors on the market and in development/under consideration.

Fig 1: Selected New Areas Where Disposables Recently Implemented

Source: 8th Annual Report and Survey of Biopharmaceutical Manufacturing, April 2011, www.bioplanassociates.com

Immediate Single-Use Adoption Trend

Other top new adoptions include buffer preparation and buffer storage (34.8% and 34.0% of respondents, respectively). In comparison, our 2010 survey showed the top ‘newly introduced’ disposable device at their facility was buffer storage (38.0%). Buffer prep introduction came in second in both 2010 and 2011, with 37.2% of respondents saying that they had begun use in the prior 12-month time frame. Here, we also note the trend from less technically complex devices such as buffer prep and buffer storage to bioreactor adoption.

Market penetration; adopter profiles

Percentage point gain in the market was another survey tool used to assess the growth in disposables’ usage. From the perspective of facilities actually implementing disposable applications between 2006 and 2011, of the 14 device types measured, bioreactors log the biggest percentage point gain. Single use bioreactor implementation grew 47.1 percentage points over the 5 year period (68% in 2011 vs. 21% in 2006).

When looking at annual growth rates, in single use device new adoption/first application , 2006-2011, we see that membrane adsorbers, bioreactors and mixing systems have the overall highest growth rate for new adoption/first application, with membrane adsorbers cited by 25.6% of respondents.

Fig 2 Selected CAGR for Single Use Devices 2006-2011

Source: 8th Annual Report and Survey of Biopharmaceutical Manufacturing, April 2011, www.bioplanassociates.com

As more companies adopt disposable technologies to reduce their initial capital investment for product development and for other operations, we studied what type of organizations are the strongest users of single use. Single-year, single use device statistics show that contract manufacturing organisations are using disposable process equipment at an even higher rate than biopharma operating companies. According to BioPlan Associates’ 8th Annual Survey’s respondents, CMOs are the predominant adopters:

All CMO respondents are using disposable filter cartridges and tubing systems 92% of CMO respondents are using biodisposables for waste containers (vs. 58.3% of biopharma operating companies) 87.5% of CMO respondents are using disposables for mixing (vs. 50.4% of biopharma operating companies) Competition among vendors is growing, and several are introducing technologies such as single use sensors and mixers to differentiate themselves from their competition. CMOs as well are biopharma organizations are adopting on these devices to support their process monitoring, overall productivity. As manufacturers overcome the challenges of using even larger systems, and complex single use bioreactor and purification devices, many end-users who are considering building future large scale commercial facilities will recognise the benefits, potential economies of scale and efficiency offered by single use technologies.

Survey Methodology: The 2011 eighth Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production in the series of annual evaluations by BioPlan Associates, Inc. yields a composite view and trend analysis from 352 responsible individuals at biopharmaceutical manufacturers and contract manufacturing organizations (CMOs) in 31 countries. The methodology also encompassed an additional 186 direct suppliers of materials, services and equipment to this industry. This year's survey covers such issues as: new product needs, facility budget changes, current capacity, future capacity constraints, expansions, use of disposables, trends and budgets in disposables, trends in downstream purification, quality management and control, hiring issues, and employment. 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 in the U.S. and Europe.

REFERENCES

[1] 8th Annual Report and Survey of Biopharmaceutical Manufacturing, April, 2011, BioPlan Associates, Inc. http://www.bioplanassociates.com/

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Single Use Bioreactors Lead in New Use and Market Penetration

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