Driven by time and cost pressures, the pharmaceutical industry is increasingly motivated to develop biopharmaceuticals for pipeline security because these products have demonstrated profitability. And as the development of biologics grows in parallel with the need to improve productivity and lower costs, biomanufacturers continue to embrace new technologies, such as singleuse devices and systems, to streamline biomanufacturing. More and more sponsors are relying on CMOs with the appropriate expertise in this area to manufacture their biologics efficiently.
This article describes trends in biomanufacturing, based on reports from Nice Insight and other industry organizations, the increasing adoption of single-use devices to improve productivity, and why sponsors are partnering with contract organizations that have efficient automated systems for bioprocessing.
Trends in Biomanufacturing
According to a 2015 Nice Insight Annual Pharmaceutical and Bio-technology Outsourcing Survey, the percentage of respondents from traditional pharmaceutical companies whose businesses are engaged in developing biologic-based therapeutic drugs has risen significantly over the past three years from 65% in 2013 to 82% in 2015. The largest increase is from emerging pharmaceutical companies, which have increased the proportion of their biologics development by 33% (to 81% in 2015 from 48% in 2014), followed by specialty pharma with an increase of 21% (now 86% from 65% in 2014), and Big Pharma with an increase of 8% (now at 90%).
The Nice Insight survey of 2,300 pharmaceutical and biotechnology executives involved with outsourcing shows that 30% of sponsors in North America and 25% in Europe outsource biomanufacturing. Of the North American sponsors who outsource biomanufacturing, 53% (56% in Europe) will outsource mammalian cell line based biomanufacturing, while 74% (83% in Europe) will outsource microbial based manufacturing.
The changes in spending on CMO/CRO services clearly reflect the market growth mentioned earlier. The percentage of outsourcing budget spent on biologics compared to the amount spent for small molecule therapeutics has risen 3% for specialty pharma and Big Pharma -- both now spending 58% on biologics, compared to conventional therapeutics at 42% – while emerging pharma has slightly reduced its budget spend for biologics by 4% (to 54%).
While the percentage of survey participants whose companies spend more than $50 million on outsourcing has remained fairly stable over the last three years, the percentage of respondents whose companies spend $10 million to $50 million on outsourcing has increased dramatically, from 38% to 62%, while the percentage of participants whose companies spend less than $10 million has decreased by slightly more than half.
The Rise of Single-Use Technologies
Disposable, single-use bioprocessing technologies have established themselves as a widely acceptable choice at the preclinical and clinical production stage, and are gaining rapid acceptance by biopharmaceutical companies worldwide as a reliable alternative at the commercial manufacturing stage.
According to a BioPlan Associates 2015 report on biomanufacturing, more than two-thirds of biomanufacturers and suppliers (69%) report improvements in biomanufacturing performance at their facility over the past 12 months due to the use of disposable devices. The report also shows that more than 90% of facilities are using single-use/ disposable technologies, and manufacturers and suppliers are comparing them with stainless-steel options when planning their manufacturing strategies.1
Single-use devices benefit CMOs in particular, with 86% reporting improvements to their productivity, compared to 66% of biotherapeutic developers who report improvement. Their greater advantage for CMOs is attributed to the ease of use and the efficiency of these systems and devices when dealing with multiple products and bioprocesses that require fast turn-around times.1
The reasons for the rapid, worldwide acceptance of single-use disposable devices and systems include a reduction in contamination rates, and enhanced production throughput efficiency, resulting in decreased manufacturing operation and maintenance costs for biopharmaceutical manufacturers. Other reasons include the reduction of process change lead times in qualifying and commissioning the manufacturing systems, greater design flexibility and expedited delivery when process and device changes are required, compared to comparable stainless-steel hardware components. Further advantages are the reduction of change control documentation costs and time achieved by using polymeric materials with known qualification, and overhead costs in labor and materials when using single-use technology in pilot plants and full-scale manufacturing.2
Customer reports at Sartorius demonstrate that after 10 years of active use, single-use products are shown to reduce capital cost by 40 to 50%, reduce operating costs by 20 to 30%, and can reduce the time-to-build by 30% when compared with traditional stainless-steel technology. Formal standards for single-use technologies, anticipated to be issued in late 2015 or early 2016, are expected to drive an increase in their use and give endusers more confidence when implementing and integrating single-use systems into commercial manufacturing.3
Concerns about single-use products still exist, such as assuring product quality and integrity, as well as vendor supply-chain security. These problems occur primarily from lack of enforceable standards for single-use systems from regulatory authorities, which results in vendors using a variety of different testing methodologies. Currently, only industry guidelines exist.
Implementing single-use systems and integrating them into manu-facturing operations, which can be inefficient, is the single most important biomanufacturing trend or operational area that the industry must focus on this year, according to another recent BioPlan survey of CMOs.4 Increasingly, CMOs are becoming frustrated with how to efficiently integrate them into their current biomanufacturing operations in standardized, easier-to-use ways.
Outsourcing Biomanufacturing
As shown above by the Nice Insight surveys, biomanufacturing activities are increasingly being outsourced and budgets are increasing. Nearly a third of sponsors in North America and 25% in Europe outsource biomanufacturing to cost-effective CMOs. Typically, CMOs adopt new technologies at a greater rate than biotherapeutic developers, since developers have already invested considerable capital in their current systems and are slower to change.
When choosing a CRO or CMO for biotechnology services, 67% rely on industry research, followed by consultants at 59% and referrals, 54%.
Outsourcing practices today have evolved into more of a partnership arrangement, where CROs and CMOs are engaged, in part, for their external knowledge and technical expertise. When Nice Insight asked survey respondents to consider a dozen different quantifiable traits for choosing an outsource company in a 2014 survey, 74% of survey respondents whose business was involved in developing biologics said technical expertise was very important when selecting an outsource partner, second only to 75% who chose "having a track record of success."5 Both qualities drive CMO and CRO engagement when it comes to biologics.
If you want to learn more about Nice Insight, the report or about how to participate, please contact Nigel Walker by sending an email to [email protected]
References
- Lupis JC and Langer ES. Critical Trends Driving BioManufacturing Production Strategies. Pharma Manufacturing. June 3, 2015. Accessed at: http://www.pharmamanufacturing.com/articles/2015/trends-driving-biomanufacturing-production-strategies/
- Trotter AM. Adoption of Single-use Disposable Technology in Biopharma Industries -- Manufacturing, Economic and Regulatory Issues to Consider. American Pharmaceutical Review. March 30, 2012. Accessed at: https://www.americanpharmaceuticalreview.com/ Featured-Articles/39300-Adoption-of-Single-use-Disposable-Technology-in-Biopharma- Industries-Manufacturing-Economic-and-Regulatory-Issues-to-Consider/
- Hernandez R. Top Trends in Biopharmaceutical Manufacturing: 2015. Pharmaceutical Technology;39(6). June 2, 2015. Accessed at: http://www.pharmtech.com/top-trends-biopharmaceutical-manufacturing-2015,
- Lupis JC and Langer ES. Demanding Easier-to-Integrate Single-use Devices. Contract Pharma. May 6, 2015. Accessed at: http://www.contractpharma.com/issues/2015-05-01/view_columns/cmos-demanding-easier-to-integrate-single-use-devices/
- Hammeke K. As Biologics Development Rise at Pharma Companies -- What Does it Mean for Outsourcing? BioProcess Online. February 3, 2014. http://www.bioprocessonline.com/doc/as-biologics-development-rise-at-pharma-companies-what-does-it-mean-foroutsourcing-0001
