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BIO INNOVATION NOTES REPORT LIFESCIENCELEADER.COM MARCH 2014 20 Survey Methodology: The BioPlan Annual Survey of Biopharmaceutical Manufacturers yields a composite view and trend analysis from over 300 responsible individuals at biopharmaceutical manufacturers and CMOs in 29 countries. The survey included over 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 puriļ¬ cation, quality management and control, hiring issues, and employ- ment. 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. What has your organization done to assure consistent quality in raw material and ingredient supply? Demanded our suppliers demonstrate higher levels of GMP/GLP compliance 2013 2012 2011 Implemented more dual-sourcing Audited more of our suppliers (e.g. those supplying our suppliers) Figure1 Source: 10th Annual Report and Survey of Biopharmaceutical Manufacturers, April 2013. BEST PRACTICES IN BIOMANUFACTURING SUPPLIER RELATIONS: REDUCING RAW MATERIALS RISKS By E. Langer 50.0% 46.9% 46.9% 39.2% 45.9% 40.5% 42.3% 39.4% 49.0% We also evaluated how CMOs behave. In this instance, we found: CMOs audit their suppliers less fre- quently (30 percent vs. 40.7 percent for biotherapeutic developers). CMOs implemented dual sourcing less frequently (30 percent vs. 50 percent). Consistent with that study, though, was the trend for CMOs to be more likely to audit more of their suppliers and sec- ondary suppliers (60 percent vs. 44 per- cent of biomanufacturers). In our study, CMOs also appeared more likely to verify vendors' certificates of analysis (60 per- cent vs. 33 percent) and to manufacture some ingredients in-house (20 percent vs. 5.6 percent). The differences between how CMOs and biomanufacturers approach ele- ments of materials supply-risk mitiga- tion are likely due to their varied busi- ness models rather than to a differing commitment to the task. For example, biomanufacturers could request that their CMOs audit certain suppliers for them. Further, because CMOs deal with more diverse products and suppliers, they are necessarily going to be conduct- ing a broader array of audits. Both CMOs and biomanufacturers do agree on the value of more and better communication with their suppliers. Our study found a hike in the percentage of respondents who reported holding more frequent meetings or calls between their quality staff and their suppliers' quality/manufacturing staff. This jump appears to have been largely driven by CMO respondents, none of whom in prior years had reported increasing their com- munication efforts. This is consistent with separate results from our survey in which communication problems with their clients shot to the top of CMOs' complaints. In fact, every single CMO respondent to the study said that "clients not communicating effectively" was at least a "common problem" in dealing with their clients. That 100 percent rate was up from 80.4 percent just three years prior. Together, the data strongly indi- cates that CMOs' best practices in client management include paying more atten- tion to better, more effective communica- tion in order to resolve potential issues. FOCUSING THE MATERIALS MANAGEMENT MICROSCOPE Materials and supply chain manage- ment and oversight are becoming even more essential as the industry continues to adopt single-use/disposable biopro- cessing equipment. Here, bioprocessing equipment is repeatedly purchased, used, and disposed of, rather than being per- manently installed and operated by inter- nal staff. Repeated equipment purchases (with essentially every piece of equip- ment in contact with the process stream) involve hundreds of new and fully sterile products for each bioprocessing run/ batch. Single-use systems require more rigorous control of related supply chains, compared with rather standard- ized stainless-steel equipment. Going forward, we can expect users will want more documentation from suppliers showing component suppliers' compli- ance with regulatory requirements. This will lead to more pressure on suppliers to demonstrate higher levels of compliance, broadening the scope of their audits. L 0 3 1 4 _ B i o _ I n n o v a t i o n _ N o t e s . i n d d 2 0314_Bio_Innovation_Notes.indd 2 2 / 1 9 / 2 0 1 4 2 : 0 9 : 0 9 P M 2/19/2014 2:09:09 PM