Eurofins Lancaster Laboratories – The Premier Bio/Pharmaceutical Testing Partner
Finding a trusted laboratory services provider in the pharmaceutical industry can be a daunting task. It is often difficult to find a service provider that offers the right mix of technical experience, breadth of capabilities, global reach and regulatory expertise. Eurofins Lancaster Laboratories, headquartered in Lancaster, Pennsylvania, is such a company with optimal capacity and expertise to assist bio/pharma companies with their analytical testing needs.
Recently, American Pharmaceutical Review met with the company’s Vice President of Business Development and Project Management, Mike McDowell, for a tour of their Lancaster facility and to learn more about the company’s capabilities, their state-of-the-art facility and their continued growth.
History, Organization, Strategic Outlook
As a member of the Eurofins BioPharma Product Testing Group—the largest network of harmonized GMP bio/pharmaceutical product testing laboratories worldwide, Eurofins Lancaster Laboratories provides comprehensive laboratory services to support all functional areas of bio/pharmaceutical manufacturing, including method development, microbiology, process validation and quality control.
With a focus on GMP bio/pharma product testing and 57 years of expertise, Eurofins Lancaster Laboratories provides a wide range of services to all sizes and types of biopharma and pharmaceutical companies, from small virtual companies to the largest multi-national corporations and CMOs. Services includes testing of all starting materials, process intermediates, drug substances, finished products and manufacturing support accomplished through the company’s expertise in biochemistry, molecular and cell biology, virology, chemistry and microbiology.
McDowell explains that Eurofins is a global life sciences company focused primarily in three areas: food, environment and bio/pharmaceutical testing. The bio/pharmaceutical group is divided into multiple verticals, with laboratories supporting the full spectrum of the drug development process, including Discovery, Preclinical/Early Development, Genomics, CDMO, GMP Product Testing, as well as Clinical and Specialty Diagnostics services. According to McDowell, being acquired by Eurofins in 2011 and joining the network of Eurofins BioPharma Product Testing Group has been a very positive experience.
“As a decentralized Group, what Eurofins Scientific really looks for is a very entrepreneurial spirit from senior management at each of its 400 global sites,” says McDowell. “So decisions on the market, decisions on positioning relative to the market, decisions on strategic investments based on where we see the market going, all that’s handled at our (local) level, which is a fantastic thing.”
Eurofins Lancaster Laboratories has a deep rooted commitment to investing in its infrastructure, technology and people, as well as continually enhancing and expanding service offerings to meet clients’ needs.
And to that end, the company has embarked on a very aggressive capital investment and construction program along with state-of-the-art technology and training initiatives to enforce its resolve to offer clients robust and innovative testing services with high-quality data integrity and continue to serve as the industry leader for decades to come.
Physical Growth
There are not many things that speak to the health of a company more than physical growth. At Eurofins Lancaster Laboratories this health has resulted in several capital improvement projects and upgrades. Perhaps the most visible indication of the strength of the company is the current construction of a five-story, 168,000 square foot addition to the current building located on a 71-acre campus in Lancaster, PA. With completion slated for end of 2018, this expansion will grow the building footprint to more than a ½ million ft2. This construction project has the distinction of being the largest construction project ever at the Lancaster campus and the biggest among Eurofins’ 400 worldwide locations.
In 2017, Eurofins Lancaster Laboratories completed a new, state-ofthe-art 17,000 square foot Stability Building, bringing the campus’s overall stability storage capacity to 80,000 cubic feet amongst 80 chambers. This addition of increased storage space for stability testing is another way Eurofins Lancaster Labs is differentiating itself from its competitors and providing its current and future clients with storage-only options and storage/testing capabilities not available elsewhere.
Eurofins Lancaster Laboratories has also embarked on a campuswide program to update and renovate dozens of laboratories to maximize efficiencies, streamline processes for LEAN strategies and to upgrade the labs to better work with the latest lab technologies and systems.
Technology Infrastructure
In addition to the physical upgrades you can see at Eurofins Lancaster Laboratories, there are those you can’t necessarily see, but have a similar, if not greater impact on the quality of services the company provides, which are the upgrades they are implementing to their IT infrastructure. Eurofins Lancaster Laboratories has made significant investments in developing a new Lab Information Management Systems (LIMS) called eLIMS BPT, as well as other systems such as Customer Relationship (CRM) systems and ComLIMS systems, which enable the company to effectively communicate with its clients.
In addition, Eurofins Lancaster Laboratories has recently enhanced its Electronic Lab Notebook (ELN) platform to drive harmonization of procedures, efficiency of data entry and access, and standardization of documentation practices.
“As part of our value proposition, we want to have a cutting-edge LIMS system. Also, we want to be at the forefront of the industry with our secure data access portal, LabAccess.com,” says McDowell. “We continue to make investments to enhance the capabilities of this platform to give clients real-time 24/7 access to data that is uploaded on a continual basis.”
He continues, “Our LabAccess.com portal gives clients information onthe status of their samples throughout the duration of a project, as well as the final certificate of analysis at the end. We’re the only company in the industry that provides our clients with all the raw data associated with their samples. Right now, this is provided in a static PDF format, but we are working on upgrades to allow clients to take that data, manipulate it into different types of reports and spreadsheets. Also, they’ll be able to look at chromatograms, and do scaling, do overlays, really work with the raw data sets that we have.”
“All of these system upgrades have been done with the customer in mind,” says McDowell. And notably, the company has expanded the global reach of these technology enhancements through close collaboration and harmonization across Eurofins BioPharma Product Testing’s network of 28 laboratories in North America, Europe and Asia-Pacific.
Training and Data Quality
During the past five decades, Eurofins Lancaster Laboratories has built a reputation for its quality program, ensuring processes and data meet clients’ goals and global regulatory compliance requirements. It is through the aforementioned investments in technology, along with continuous improvement to the company’s rigorous quality systems and extensive, ongoing training programs that they continue to lead the industry in quality and data integrity.
Through comprehensive leadership, soft skills, and extensive technical training programs, the company has invested in the tools for every employee to achieve their development goals.
Also critical to the company’s success is its ability to improve operations through its LEAN program. With more than 100 employees trained in LEAN this past year, Eurofins Lancaster Laboratories’ LEAN effort continues to gain momentum helping the company reach its organizational performance improvement objectives.
New Service Offerings
As the company strives to provide innovative, timely and cost effective scientific solutions to help customers better manage the drug development process, team members continually examine areas where they can grow with their clients and add value to their relationships.
“Our newest service offering,” says McDowell, “is the Medical Device Testing business that was recently established at our Lancaster campus. With our advanced Package Testing facility, Micro Sterility Suites, and Container Closure Integrity Testing capabilities, we are working to have one of the most comprehensive Medical Device Testing offerings in the market place. With the focus on drug delivery from our existing BioPharma clients, this is a logical extension of our existing service portfolio. We also added a new Molecular Lab, and we are rapidly growing our list of qPCR assays and are making investments in instrumentation from our Orbitrap Fusion Lumos MS for advanced proteomics to robotics for high volume subsampling and aliquoting.
Working with Clients
There has been a lot of discussion across the industry about the best way to approach using contract service providers, and as McDowell points out, there are many differing opinions. “Companies’ outsourcing strategies are as varied as the number of modalities and drug products in the marketplace. Our approach is to understand each companies’ individual goals and objectives. Once we understand the client’s needs, we evaluate our ability to provide a solution, and customize our service, to help the client achieve their objectives. So, when it comes to describing the breadth of services offered by Eurofins Lancaster Labs and its Unique Value Proposition (UPV), McDowell points to his company’s single-source approach. “Because of the size of this organization, you can imagine for the companies that do want to outsource everything, or at least a significant amount of testing, there’s tremendous value in being able to send that all to one organization.”
Also, the company has implemented three unique testing service programs to provide current and future clients with increased flexibility.
In addition to the industry-standard Fee for Service model, Eurofins Lancaster Laboratories offers Professional Scientific Services® (PSS) Insourcing Solutions and Full-Time-Equivalent (FTE) service models. The PSS service model places Eurofins Lancaster Laboratories’ people at the client’s site and is dedicated to running and managing laboratory services while eliminating headcount, co-employment and project-management worries.
The FTE service model offers a dedicated team to a single customer within Eurofins Lancaster Laboratories’ facility. This model provides a high level of expertise with technical and productivity enhancements, and offers integration and customization to meet specific testing needs with the ability to track the performance of the team.
Looking Ahead
As can be seen by their efforts to date, Eurofins Lancaster Laboratories is making huge investments in physical facilities, IT, staff training, and capital equipment. This commitment to providing a best-in-class facility along with the expertise and experience of personnel, will certainly cement the company’s place as the premier provider of GMP bio/pharmaceutical testing services for decades to come.