EBPT Portage enhances and expands Microbiology capabilities portfolio; continuous collaboration with Lancaster Micro serves clients well
by Jennifer Foote, Manager of Microbiology and Site Operations; Nathan Whitford, Site Director; Eurofins BioPharma Product Testing, Portage, MI
As the Eurofins Lancaster Laboratories, site in Portage, MI, continues to grow, the microbiology team has been no exception. With a focus on non-sterile product testing, the team has continued to grow and add testing capabilities to complement the drug substance and finished product testing supported by the site.
The site’s controlled access microbiology laboratory is equipped with a validated sterilizer and six biological safety cabinets capable of handling BSL2 materials. This has enabled the team to develop routine partnerships to provide microbiological services that include bioburden, growth promotion, microbial limits, water activity, environmental monitoring, and process water testing. With this testing, the Portage microbiology team has steadily built a reputation for consistently achieving client turnaround times, including rush requests, with no less than 93% of testing meeting turnaround time for the last two years. This turnaround time accomplishment has been enabled by implementing systems related to a LEAN laboratory design and improved documentation. Included in this process is the use of documentation processes in electronic laboratory notebooks (ELN) that continue to be expanded across all current microbiology service offerings. The use of ELN allows for maximizing testing efficiency while reducing errors related to documentation. Additionally, this allows for reduced review times and flexibility with the staff to accommodate a variety of schedules.
As part of our efforts toward continual improvement, new LEAN initiatives have been implemented to streamline data review practices and restructure the organization and process flow of media production. With the recent addition of the site’s first LEAN industrial engineer, we will be selectively identifying further areas for improvement through process mapping and appraisal of our micro laboratory practices.
As the team in Portage has continued to grow, additional testing capabilities are being added currently and in the future. Most recently, the team has added Antimicrobial Effectiveness Testing (AET) for non-sterile products. With this addition, the team continues to focus on professional development of the growing staff. This allows for the expansion of technical skills at both the scientist and leadership levels so the team can continue to ensure members are current in microbiology service offerings and maintaining awareness to industry trends.
As a smaller laboratory site, the Portage team has been known to collaboratively partner with the technical leadership within our client’s teams. This technical collaboration has proven to be very beneficial in onboarding new project work, interpreting client testing needs, and providing responsive investigation updates. It also allows for flexibility when rush requests have been submitted so that client requirements and turnaround time has consistently been met. Clients have shared their appreciation of the access to the technical resources the site provides on the road toward meeting their requirements.
As the Eurofins Lancaster Laboratories, Inc. site and microbiology department continue to grow and expand on testing capabilities, we invite all of our current and new clients to evaluate this location for their testing needs. The team in Portage is excited for the new opportunities and challenges that will come as the site continues to grow.