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BIO INNOVATION NOTES REPORT LIFESCIENCELEADER.COM MARCH 2014 18 If you want to learn more about the report, please go to bioplanassociates.com/10th. E R I C L A N G E R President and Managing Partner BioPlan Associates, Inc. BEST PRACTICES IN BIOMANUFACTURING SUPPLIER RELATIONS: REDUCING RAW MATERIALS RISKS By E. Langer CMOs are more likely to audit their suppliers than biomanufacturers. Best Practices In Biomanufacturing Supplier Relations: Reducing Raw Materials Risks uality management is a mat- ter of increasing importance to the biopharmaceutical manufacturing industry. In recent years, facilities have been gravi- tating toward quality-related analytical programs, and our data tells us they are also getting tougher on suppliers. Respondents to our latest industry sur- vey — the 10th Annual Report and Survey of Biopharmaceutical Manufacturers (www.bioplanassociates.com/10th) — are adopting several key steps to manage and protect their supply chains. We asked 250+ qualified decision makers from around the world to identify what their organization had done in the prior 12 months to assure consistent quality in raw materials and ingredient supply. Half the industry respondents have "demanded our suppliers demonstrate higher levels of GMP/GLP compliance," a figure substantially higher than the 39 percent who had done so in the 2012 sur- vey. Another 47 percent said they "imple- mented more dual-sourcing," up from around 40 percent in 2011's study. In addi- tion, 47 percent stated they had audited secondary suppliers. Clearly the industry is intent on manag- ing its suppliers by more closely vetting those companies and expanding the scope of the vetting process. But those aren't the only measures being taken. Respondents also said they had audited their suppliers more frequently (46.9 per- cent), verified vendors' certificates of anal- ysis (37.5 percent), specifically identified secondary suppliers (37.5 percent), and verified the origin of individual ingredients more carefully (34.4 percent). Interestingly, relative to prior years, the proportion of respondents auditing their suppliers more frequently has retreated, while a greater percentage attest to more careful verifica- tion of individual raw materials and com- ponents. However, facilities still relying on their suppliers rather than manufacturing some components in-house (7.8 percent) said they had adopted this approach in the previous year. U.S. VS. EU: DIFFERENT APPROACHES TO MATERIALS MANAGEMENT Looking at the critical ways facilities man- age their materials supply chain, we com- pared the responses from end users in the U.S. and the EU, and we compared CMOs with all global biotherapeutic developers. With the trans-Atlantic breakdown of supply and materials management, our study found variations in approach- es between U.S. and Western European companies: Western European/EU respondents were more focused than their U.S. coun- terparts on auditing suppliers more fre- quently (58.8 percent vs. 34.3 percent). Specifically, EU companies identify, and presumably validate, secondary sup- pliers more often than U.S. respondents (58.8 percent vs. 37.1 percent). U.S. respondents were interested in implementing more comprehensive audits (45.7 percent vs. 23.5 percent for EU). U.S. facilities tend to develop new, more rigorous tests for incoming raw materi- als/supplies (31.4 percent vs. 17.6 percent). 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 1 0314_Bio_Innovation_Notes.indd 1 2 / 1 9 / 2 0 1 4 2 : 0 8 : 5 8 P M 2/19/2014 2:08:58 PM