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BIO INNOVATION NOTES REPORT LIFESCIENCELEADER.COM APRIL 2014 22 Survey Methodology: The BioPlan annual survey of biopharmaceutical manufacturers yields a composite view and trend analysis from more than 300 responsible individuals at biopharmaceutical manufacturers and CMOs in 29 countries. The survey included more than 150 direct suppliers of materials, services, and equipment to this industry. This year's study covers such issues as new product needs, facility budget changes, current capacity, future capacity constraints, expansions, use of disposables, budgets in disposables, trends in downstream purifi cation, 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. Quality Initiatives Currently Being Implemented or are Planned for Implementation Within the Next 12 Months Currently implementing Planning within next 12 months Figure1 Source: 11th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, BioPlan Associates, Inc. be in the planning stages. And it seems likely that some who were planning to implement various initiatives last year are now following through. For example, in our latest survey, when we identi- fied companies in the earlier planning stages, we found that 12.3 percent said they planned to implement QbD within the next 12 months, down from 19.7 per- cent last year. That was one of the larg- er swings, and for the most part there wasn't a marked increase in planned implementation to go along with the rise in actual adoption. PAT (process ana- lytical technology) did rise somewhat in terms of those entering the planning stage (vs. actual implementation stage) — some 21.9 percent of respondents to this year's survey said they planned to adopt it in the next 12 months, up a few points from last year's 18.3 percent. The data indicates that many firms have already implemented a range of initiatives, from QbD to process model- ing. Those companies that have yet to implement will likely do so in the coming years. The data regarding quality initia- tives being implemented in the next year shows that 10 of the 12 different types of quality-related analytical programs we identified are each expected to be implemented by around 10 to 25 percent of respondents, so one or more of these specific initiatives are likely to be imple- mented by the majority of facilities. Much of the motivation influencing companies to implement these programs involves keeping up (or catching up) with regulatory expectations and industry best practices. More developers are now filing applications developed using these quantitative quality-related programs, and the inclusion of this data in regu- latory filings is ultimately going to be expected by regulators. The industry can expect other ben- efits from adopting these quality ini- tiatives. These include manufacturing higher-quality products through better designed and optimized bioprocessing, likely along with considerable savings as problems are avoided and processes are further optimized for increased efficien- cy. The use of quantitative bioprocessing data management and processing for the purpose of more fully understanding and improving products is now an estab- lished part of the biopharmaceutical industry — and is expected by regulators. It's likely that cost-saving programs such as PAT and QbD will be adopted by the majority of developers and manufac- turers in coming years. Between current and planned adoption of the various ini- tiatives we listed, the majority could see adoption rates of at least 60 percent by the end of this year, if respondents follow through with their expectations (admit- tedly, a big "if "). One challenge that must be addressed is integrating quality initiatives such as QbD into existing working quality and manufacturing systems. And ultimately, the success of initiatives such as PAT and QbD in biopharmaceuticals will depend on better sensors and analytical soft- ware. Computing power is now adequate. Better analytical data and analyses can allow biomanufacturers to make a strong business case for wider adoption of these tools to maximize yields, obtain purer product, and minimize quality defects. L BEST PRACTICES IN QUALITY MANAGEMENT: INDUSTRY'S APPROACH TO QUALITY INITIATIVES By E. Langer Risk Management/Analysis 64.5% 9.6% Risk Analysis/Failure Mode Effects Analysis (FMEA) 65.8% 11.0% Platform Manufacturing Processes 64.4% 9.6% 0 4 1 4 _ R e p o r t s _ B I . i n d d 2 0414_Reports_BI.indd 2 3 / 2 1 / 2 0 1 4 1 2 : 2 2 : 0 0 P M 3/21/2014 12:22:00 PM