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The Elephant in the Room: Modernizing Non-Compliant Sterile Facilities

by Hite Baker According to DME Facility Focus, an industry-wide survey of the life sciences industry conducted by DME in partnership with INTERPHEX, we asked cGMP manufacturers to weigh in on facility modernization coupled with the challenge of achieving closed processing in legacy facilities. Our results show that 27% of the respondents plan to modernize proactively. The troubling news is that almost half the respondents (44%) do not plan to pull the trigger on modernization unless driven by FDA scrutiny or product quality problems—in other words, a crisis situation. Surprisingly, another 17% do not plan to modernize at all. For those manufacturers who are planning to upgrade a legacy facility, the majority stated it would occur sometime in the next 5 years (66%).[...]

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    DME would like to congratulate all project participants for West Pharmaceutical Services, Inc.’s Kinston, NC expansion project, which recently received an honorable mention for the ISPE Facility of the Year Award (FOYA). The FOYA committee is awarding West an honorable mention for their industry leading efforts to align primary components manufacturing process with current industry trends and standards. About the Project As biopharmaceutical companies continue to bring new molecular entities to market, components play a significant role in preserving the integrity and efficacy of drugs. In addition, regulators are paying more attention to components that come into direct contact with the drugs. Vials, stoppers and syringes, if not properly manufactured, processed, packaged, and shipped, have the potential to render pharmaceutical products adulterated[...]

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