As the need for fast, efficient, and high-quality bio/pharmaceutical testing services continues to grow, industry service providers are expanding and upgrading their capabilities to best serve their current and future partners.
Eurofins BioPharma Product Testing offers a network of more than 40 laboratories purposely designed to cover the entire drug development process with global coverage, uniform quality assurance systems, and best-in-class testing services.
Eurofins BioPharma Product Testing’s Portage, MI, facility is one of the sites in the company’s network that provides GMP testing services to the bio/pharmaceutical industry and has seen incredible growth recently in both the size of its facilities and with the addition of new services and capabilities.
Background
The Portage facility was originally constructed in 1990 by AvTech Laboratories as a 20,000 square foot laboratory to support the company’s microbiology, clinical trials, and GMP finished product testing. Eurofins purchased the facility in 2005.
Angela Smith, a 17-year veteran scientist and leader with the Eurofins’ Lancaster, PA, site and new site director for the Portage facility, adds, “This was actually the first site that Eurofins purchased within the BioPharma Product Testing group in the United States. Shortly after it was purchased, Eurofins added an additional building to expand the capabilities here in Portage.”
The additional building doubles the capacity, giving Eurofins room for future growth.
Current Services
Eurofins has been putting that space to good use as the site focuses on small molecule finished product testing for chemistry and microbiology services. This includes method development, method transfer/validation, release, and stability storage for early to late phase programs. New expansions in small molecule product testing included adding additional instrument capacity and new instrumentation, including IC and LC/MS in 2022. Within the microbiology business, the site has been performing non-sterile product testing such as microbial limits testing (MLT) and antimicrobial effectiveness testing (AET) for many years. The addition of raw materials testing, along with sterile product microbiology services complements the current Portage offering while providing greater options for their clients.
Smith relates how the Portage site works directly with other sites in the Eurofins BPT network, specifically the Lancaster, PA, facility, “What we’re adding right now to our facility here in Portage is raw materials capabilities, and we are working directly with the Lancaster site to identify some of the most common raw materials. We’re making sure that we have the instrumentation and the space design to meet those needs for our clients.”
Smith continues, “Recently, we’ve been working with the Lancaster facility to harmonize raw materials testing across both sites to serve as additional capacity to support our clients deadlines.”
Eurofins’ Lancaster site has been offering raw material testing for decades and offers an experienced, industry leading team of more than 200 subject matter experts. These experts were intimately involved in helping the Portage site establish their services, designing and setting up the lab, and selecting instrumentation, along with a myriad of other details.
Nathan Whitford, who had been the site director at Portage since 2012 and is currently moving on to become the President at Eurofins’ Columbia, Missouri facility, added more detail to the collaboration seen in the Eurofins network, “We’ve been planning this and meeting with the Lancaster raw materials leadership team for over a year now. They’ve been integral to the process. It’s been awesome to collaborate with them and go through the planning stages and really look to see what are those highly requested tests, and monographs, which will provide a strong service offering to our clients. The leadership team in Lancaster also gave us advice and details to look for from a laboratory setup instrumentation perspective. Training is also important and fortunately we have the flexibility of sending analysts back and forth between the labs for training as needed. The ability to be integrated and harmonized with the rest of the organization is really a value-add for our clients.”
Expanding Microbiology Services
One of the main reasons for the building expansion at the Portage site was to add to, and enhance, the company’s microbiology services. At the site, Eurofins added genetic sequencing capabilities for microbial identification purposes on site along with endotoxin testing capabilities. The team at the Portage site also installed new sterility isolators to mirror technology that the Lancaster team has recently validated, which will allow for sterility testing to be performed there. These capabilities at the Portage location will allow for a more complete service offering of microbiology testing for the company’s clients.
Whitford explains, “The goal is to really round out the services that we can offer from a microbiology testing perspective. We’ve had great expertise in what would be non-sterile product testing, and we do a great job with those MLT and AET services. Our previous gap was microbiology testing services required for sterile products. Onboarding isolator sterility and endotoxin fills that void, and gene sequencing for identification purposes rounds out the overall capability. By adding a new microbiology lab, similar to our raw materials lab, within our network we can improve business continuity, not only for ourselves but for our clients.”
A Closer Look at Raw Materials Testing
The supply, and accurate and timely testing, of raw materials has always been an important part of bio/pharmaceutical product development.
The COVID-19 pandemic has brought this topic into sharper focus as the need for unprecedented quantities of new vaccines and therapeutics with short delivery times has expanded. Raw materials testing requires fast turnaround time due to the demand it has for drug product manufacturing. Eurofins BioPharma Product Testing offers a multi-site approach for their clients to help deliver this critical testing in the turnaround time required while expanding on its bandwidth for more and more samples.
Smith explains, “Raw materials have always been a busy focus for the Lancaster site, and the operation has continued to grow. We’ve seen substantial growth as newer and faster technologies have come in place for raw materials testing, and it’s one of the reasons we’re focusing on that area here in Portage.”
Smith adds that since the pandemic began, they are observing that their clients are often sourcing a higher volume of raw materials due to supply chain challenges to ensure that they have an adequate supply during this time period, which has driven increased testing demand.
The Benefits of a Lean Lab
Lean concepts have been applied to bio/pharmaceutical testing and production for a while now. But the need to implement Lean has never been more important than in the current industry climate of getting treatments out to market as quickly, and efficiently as possible. Eurofins recognizes that Lean is tremendously important for its customers on many different levels. Designing laboratories with Lean concepts in mind allows for improved flow of samples with faster turnaround times. However, the concepts go well beyond speed by driving more organized laboratories that analysts have a greater desire to work in while improving quality, the look of the lab, and a safer laboratory environment for all.
“We see an improved flow for samples, which results in faster turnaround time, as well as reduced errors. In addition, we utilize Lean concepts to organize and manage reagent and standard supply to ensure adequate inventory and minimize disruptions to work flow, allowing analyst to focus on the work,” says Smith.
Seamless Global Services
When engaging the services of a contract research and testing organization, pharmaceutical companies are keen to receive the same level of service wherever they may be in the organization’s network.
Eurofins has seen a greater need and demand for business continuity and continued support from laboratories without having any disruption of services to the overall supply chain. Having shared instruments, platform methods, LIMS, and harmonized SOPs between their sites offers greater flexibility for clients and improved service. The company can offer the same, validated methodology at multiple sites and (with permission from clients) can test their product, excipient, or raw material at either site to allow for the best TAT available without compromise to the quality of their product. Many clients have embraced this multi-site qualification process, which improves their service through supply and demand difficulties as well as business continuity improvements that have been shown to be critical throughout the pandemic.
Whitford adds more detail regarding the seamless collaboration between Lancaster and Portage, “From 2012 there was a clear focus to harmonize SOPs, LIM systems, and things of that nature to have one product and ability to serve our clients at multiple locations. That was a key. Certainly, as we bring in different services and have new people joining the organization, we’re constantly looking to see how we can do things in the most efficient manner. There are best practices that are shared from either site back and forth. That’s what makes for a continually improving environment from that perspective.”
Whitford continues, “Continuous strategizing among staff and sites to further enhance the customer service experience and create a more efficient and innovative workplace for employees is what drives us. Having been a laboratory leader in Lancaster for 15 years previously, there is great trust in our colleagues in Lancaster to advise on helping us make significant improvements at our growing Portage site, not only from a facilities perspective, or a Lean organization perspective, but from an SOP perspective.”
Long-Term Goals
Looking forward, Eurofins and the team at the Portage site anticipate future growth. The company is currently in the process of evaluating another laboratory expansion. By continuing to design Lean laboratories, Eurofins Biopharma Product Testing can add more capabilities to ensure that they keep up with current and future client’s demand for high throughput testing, with fast turnaround time and uncompromised quality.
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