For bio/pharmaceutical companies to bring a new product to market, many things have to go right.
From the time a new, potentially therapeutic substance is discovered to the time it is available to consumers, the clock is ticking. Bio/Pharmaceutical companies need to launch new products as quickly as possible, yet still maintain the highest levels of quality - a quality that is demanded by regulatory agencies and the public.
Therefore, suppliers and service providers to the industry must continually fine-tune their capabilities, adding innovative and differentiating services, honing staff expertise, and constructing new facilities to help their clients win the race to market.
Eurofins Lancaster Laboratories, a premier global supplier of analytical testing services to the bio/pharmaceutical and medical device industries, has embarked on a strategy that offers their clients cutting edge services and expertise, state-of-the-art facilities, quality data, and scientific solutions they can trust.
The company’s ambitious growth plans have encompassed many upgrades and 13 building expansions to their campus in Lancaster, Pennsylvania, since its founding in 1961. Recent enhancements include best-in-class laboratory information management systems, implementation of LEAN strategies, and upgraded instrumentation and laboratory facilities.
Perhaps the company’s crowning achievement, however, is the completion of their latest 168,000 square foot, five-story building addition designed to incorporate the latest LEAN technologies to streamline processes and workflows to enhance the customer service experience and ensure speed-to-market remains a top priority.
Meeting Client Needs
Neal Salerno, President, Eurofins Lancaster Laboratories, details the business and market decisions that led to the construction of the new facility.
“One of the benefits of a partnership with Eurofins Lancaster Laboratories is that we are a “one-stop” facility where a bio/pharmaceutical company can come here and get any testing they might possibly need--from starting materials through process intermediates, bulk delivery, drug products, and packaging--the entire value chain for every drug development program.”
Salerno continues, “Offering these services in one location is a huge value to our customers. And our new building is a continued enhancement to ensure that as new product technology comes online, we are ready and able to help facilitate its testing and help our clients get to market faster.”
In addition, Salerno mentions the changing dynamics and regulations within the industry as another reason for the construction of its new building expansion, “Between data integrity requirements and the increased importance of testing throughout the entire pharmaceutical life cycle value chain, we saw that as an opportunity to extend our capabilities and our processes, and this significant addition is a culmination of our desire to serve the industry and help our partners succeed.”
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Supporting Research and Emerging Technology
“The bio/pharmaceutical industry is the most research intensive industry in the word," Salerno explains. “We are fortunate to support some of the most innovative, creative, and scientifically advanced companies in our industry. When you work on the cutting edge, the pace of change is staggering. Constant investment to keep up with our client’s needs has become part of our company culture. One emerging technology is gene therapy, and we support most leaders in the field. To better support these clients, we have significantly expanded our BSL2 capacity. We can support all testing required for release of gene therapy products, quickly and efficiently, at our Lancaster campus. A second emerging technology is Antibody Drug Conjugates (ADCs). In a quest to better treat cancer patients, biopharma companies are using vectors (antibodies) that target and release a cytotoxic payload directly into a tumor cell. Classical chemotherapy treats patients systemically, making the patient very sick in an attempt to eradicate the cancer. ADC technology isolates the cytotoxin to the tumor cell. To test these drugs requires handling of highly potent/cytotoxic materials. Our campus investments include special laboratories and equipment to support this promising technology while protecting our employees.”
The New Building’s Features and Benefits
As constructed, the new building adds 50% more capacity to the company’s existing 330,000 square foot facility for a total of more than 1/2 million square feet.
Along with the investments in its microbiology services, the company has enhanced its other service offerings, including an expansion of its Extractables and Leachables Testing group for testing both pharmaceutical and medical device products. The company also has a new area dedicated to method development and testing for small molecule products.
One of the biggest features of the expansion is the inclusion of a massive cleanroom. Designed for the company’s Microbiology Testing Services, the cleanroom was designed as a response to market changes. As Salerno explains, “One of the things that we’re starting to see, especially for the Medical Device business, are products that are much larger in nature and a little bit more challenging to handle. We needed to have the capability to take some of these unique products, handle them, and test them accordingly.” And, as a modern building, one of the key features is that its design was optimized to streamline processes. As you walk through the completed building, Salerno explains, departments that work together are located in close proximity to each other. Access to rooms and areas benefit from free-flowing hallways. Sample prep and storage rooms are near the labs. All of this was done to decrease waste, improve quality and speed data delivery to clients—all of paramount importance to biopharmaceutical companies.
“Every part of the design of this building has really had some kind of LEAN assessment and design from a LEAN specification.”
Salerno continues, “How do you get testing and other tasks done as quickly as possible? We believe the more we can shrink the time frame to help get that product to market, the better. We’ve designed everything in our new building around LEAN processes to ensure that our experienced scientists have the wherewithal and the bandwidth to focus on the science while making this a great place to work.”
“It really is a very contemporary facility that has completely redesigned our flow to be able to get testing results out the door quickly, efficiently with the highest level of quality,” says Salerno.
Campus Culture
A new, state-of the-art bio/pharmaceutical testing facility can only function as designed if the people working within it are given the best environment possible.
The company believes their staff is what sets them apart from other companies in this segment of the industry.
“It’s really about our scientists and our supporting staff and how they’re working with our clients and getting regulatory compliant data to them most proficiently. We’re very well known in the industry for our stellar quality and from the partnerships we foster with our customers. That doesn’t happen without a phenomenal team.”
Employing an outstanding team means attracting and retaining top talent. The company has always cultivated a great work environment, but, with the latest addition to the Lancaster campus, the company now has taken the work environment to another level for its talented staff.
“There’s always the challenge of how do you attract and keep talent,” says Salerno. “We really focus quite a bit on that. Not only do we think that this is a wonderful company to work for, it’s just a great local area where you have a very rural and close-knit community with a cool small city, so we really are trying to work on some of the amenities for our folks that will continue to move us forward and to make this the optimal environment to grow a career, balance work/family life, and be a fun place to call home.”
True to the old adage that the way to someone’s heart is through their stomach, the new building features a brand-new cafeteria and gourmet food service. It also features numerous open areas where employees can work or take a break and also offers an outdoor seating area with an expansive patio and panoramic views the countryside.
“Our new building has a great feel to it; it’s a very sleek, open and bright building,” says Salerno. “And it will also serve as the foundation for how we modernize all the other buildings on our campus. We have begun modifications and renovations to infuse LEAN initiatives as well as give the facility one look and feel. I believe we have designed and constructed a very impressive facility that people are happy to work in.”
The company also sees their growth and success tied directly to the opportunities they offer to employees.
“As we’ve grown, we have given our folks the resources to expand both professionally and personally, and also to really take part in developing cutting edge technology. We have some of the greatest scientists in the world here, and they do amazing things supporting our clients’ quest to better the human condition,” says Salerno.
Local and Global Network
Eurofins Lancaster Laboratories is part of Eurofins BioPharma Product Testing, the largest network of harmonized GMP product testing laboratories worldwide. The company boasts four facilities in the U.S. and 30 throughout Europe and Asia. This network of facilities is very well integrated – all facilities have the same LEAN systems; customized, proprietary Laboratory Information Management System (LIMS); and harmonized quality systems in place. The sites all work collaboratively to ensure customers have the right solutions for the project – regardless of the location.
“It’s actually a very close connection between all of the sites,” says Salerno. “One of the things that we’re very proud of is the fact that the service level that you get here, is the same service level you get at all of our sites. We help from a risk mitigation standpoint so that our customers are not necessarily tied to just one facility, but there’s multiple facilities that may have your methods if that’s what the customer needs.”
The company has also invested heavily in its IT infrastructure, basically moving away from paper to a fully electronic data system.
“You can’t walk around this facility without seeing somebody with a laptop or their electronic notebook acquiring real-time data and performing instant data review. We’ve become very flexible as to how we’re doing our work, where we’re doing our work.”
IT infrastructure upgrades have allowed the company to tie all electronic notebooks to their LEAN systems and allow their LEAN systems to securely tie in with the customer’s systems, creating a seamless platform.
“Our system is world-class and one that you won’t find elsewhere in the industry. The facility is designed really around that, which is how I can, for example, be in a chamber and have wireless connection, how I can scan a product in and out versus hand typing it, and how I make sure that I have positive control over everything that I’m doing.”
Future Campus Enhancements
While most companies might take a break after designing, constructing, outfitting, and staffing a new facility, Eurofins Lancaster Laboratories is already looking at the next steps in its journey to continue to offer its current and future clients the best services possible.
As Salerno explains, a lot of thought and planning went into the design of the building, with future expansions in mind. “We’ve put the infrastructure in place for additional expansions in the future. For example, the land development and zoning was completed to include an additional 300,000 square feet of future facilities. We also accounted for future expansion when installing the wiring, such as fiber optics, switch lines, etc. On top of that, really, it’s a very advanced building.”
The recent completion of this expansion, the campus-wide improvements in IT infrastructure, the implementation of Lean strategies to improve workflow processes and time to market, the strength and breadth of the Eurofins network all culminate in a company that is keen on ensuring their clients’ success.
“All of our investments to our physical campus, combined with our dedicated staff have been done to ensure that we can handle anything and everything that our customers need in order to succeed,” Salerno concludes.