Jeffrey Heiser, Director of Microbiology
The very essence of great leadership lies in the ability of an individual to see challenges as opportunities. The story and career trajectory of two college roommates, Robert McBride and Gary Feinstein, follow a similar trail. Over 30 years ago, the founding duo of Boston Analytical, a biopharmaceutical testing laboratory, noticed the quality, accuracy, and timeline issues faced by pharmaceutical companies as an “impetus to create something new.”
McBride and Feinstein, students at the University of Massachusetts, saw that outsourcing pharmaceutical testing services and other related functions to contract laboratories helped pharma companies free up resources for redirection and brought in cost savings. However, on the flip side, it led to numerous issues with customer service. For analytical services, perhaps more so than other outsourcing activities, rapid turnaround times are crucial to client success, but most contract labs failed to meet that demand. This led the duo to establish Boston Analytical, a privately-owned firm in 1987 to offer first-class testing services. Over the next 15 years, the business grew steadily, primarily through word of mouth—both in terms of revenue as well as employees—and they achieved unprecedented successes.
Around 2009, McBride and Feinstein decided to expand the firm’s service offerings. However, the founders came to realize that they lacked the necessary resources needed to get to the next level of growth. The business needed significant investments in order to increase their infrastructure, update their equipment, and build newer facilities, and this is precisely where Alpha Analytical came in and strategically acquired Boston Analytical. Another privately-owned company, Alpha Analytical is the seventh-largest environmental testing laboratory and the largest family-owned contract laboratory in the U.S. providing high-quality and trusted analytical testing services.
“Alpha Analytical was looking to venture into the life sciences industry, and we, on the other hand, needed a financial push to expand in terms of both our service offerings as well as resources. The acquisition was a win-win situation,” says Kristin Dangelo, director of business development at Boston Analytical. The acquisition not only brought with it a wealth of laboratory operations experience but also enabled the Boston Analytical team to focus on building their microbiology and raw materials laboratories and later on, down the road, bringing in people with the required skills to further develop their microbiome testing and manufacturing expertise.
One such expert that joined Boston Analytical was Jeffrey Heiser, a microbiologist and a leader in the cGMP characterization of anaerobic live biotherapeutic (LBP) medicines. Heiser came to Boston Analytical in 2012 and currently serves as the director of microbiology, overseeing the operation of the lab in release and stability testing, validation, and environmental monitoring. Heiser has, in fact, been a critical contributor to the success of Boston Analytical’s microbiome department and responsible for setting up the testing of microbiome (LBP) products. Over the past 15 years, he has worked to develop routine testing processes and has actively participated and led the implementation of instrument and method validation as well as rapid microbiology instrument evaluation studies.
Today, Boston Analytical—recognized as the life sciences division of Alpha Analytical—is a cGMP compliant, FDA-registered, ISO-certified analytical laboratory that specializes in microbiome testing services. The firm offers testing services for both large and small molecule formulations, including analytical development, validation, microbiological, stability, and Extractables and Leachables testing. Boston Analytical also provides facilities services such as environmental monitoring and disinfectant efficacy studies. The firm’s ownership is focused on customer service and being the best employer in the industry to its employees.
Complete cGMP Microbiome Characterization Services
Talking about Boston Analytical’s venture into the microbiome space, Kristin mentions, “We first started witha spore fraction product in 2014.
Today, Boston Analytical—recognized as the life sciences division of Alpha Analytical—is a cGMP compliant, FDA-registered, ISO-certified analytical laboratory that specializes in microbiome testing services
Our microbiologists performed method development, drug product release testing, stability testing, and environmental monitoring to help the gut microbial imbalance drug advance on its development path.” Slowly, the firm began expanding its expertise to developingconsortia defined drug products and provide all of the identity, purity, and potency analyses necessary to characterize multi-strain microbiome drug products. These services include traditional microbiology and chemistry testing services, raw materials testing, drug product titering assays for the characterization of drug substance and drug product sample matrices, and tests to confirm the presence of a defined drug product strain. In order to fast track LBP characterization programs, Boston Analytical has developed a testing approach that simplifies the optimization, validation, and routine testing of LBP activity assays. Since antibiotics are often part of the clinical application of LBP medicines, Boston Analytical can characterize them in two distinct ways: USP <81>antibiotic potency testing to characterize drug concentration and antibiotic susceptibility testing according to CLSI methodology to determine the sensitivity of LBP production strains to a panel of commonly-prescribed antibiotics.
Emphasizing the value these services bring to the table, Heiser informs, “There are not a lot of regulations that exist in the current landscape that are specific to live biotherapeutics products and how they are manufactured or tested before being released for clinical trials.” While there are plenty of guidance documents from the FDA and EMEA that provide guidelines on how to characterize small and large molecules, there is limited literature supporting the regulations required to address living microbiome medicines. To that end, Heiser has leveraged his extensive expertise in multivalent vaccine production and characterization and applied it to microbiome drug product characterization to support the development of new drugs to treat diseases associated with the gut microbiome. “We use multiple tried-and-true methodologies to get the products characterized from a microbiome standpoint,” he adds.
For example, when it comes to LBP consortia products—which are manufactured with multiple different strains as drug substances before being combined into a single drug product—there is limited knowledge as to how to approach the analytical methods needed to characterize them—especially when considering cGMP compliance. Apropos of the therapeutic benefits of the products, one of the aspects that the regulatory authorities want is to ensure is that the cells remain viable throughout the manufacturing process. However, being able to characterize such products is very tricky. In light of this, Boston Analytical has invested in the latest equipment for microbiome characterization, including a matrix-assisted laser desorption/ionization-time of flight (MALDI-TOF) mass spectrometer for microbial identification. MALDI-TOF mass spectrometry helps determine the microbial ID from bacterial and yeast unknowns through the utilization of protein profiles. The instrument, software, and the method employed by Boston Analytical are fully validated for cGMP use. MALDI-TOF microbial identification testing allows for the determination the confirmation of LBP production strains within minutes.
In a nutshell, all of Boston Analytical’s services are in support of regulatory filings and getting a product into the clinic and providing support throughout pre-clinical through commercial release testing. “In regards to microbiome specific products, our level of experience and expertise performing the above is second to none, especially with the consortia products. We offer recommendations on how they should be executing the stability studies and the attributes they need to look out for,” states Heiser.
A Healthy and Passionate Work Culture
In today’s dynamic market, having a high-performance company culture is important. To that end, Boston Analytical’s leadership team follows a systematic approach when it comes to managing and streamlining the organization and its people. The firm, in fact, is well-recognized for its modern facility, expert staff, strong resources, and an agile team that is dedicated to customer satisfaction, high-quality, and timely and accurate analysis. Each team member takes ownership of their role and is given the ﬂexibility to master it. From innovative testing methods to detailed documentation and reporting, the firm delivers the information that clients need with clarity and precision. Dedicated project managers are employed that have experience specific to managing cGMP compliant microbiome programs and are committed to it. “We believe that great service goes beyond simply analyzing products. When you work with Boston Analytical you’ll receive a dedicated team who will help you establish key goals and opportunities, build effective strategies, achieve a regulatory threshold in order to get to clinical trials quickly, and provide the right mix of services to meet your unique objectives,” affirms James Mich, president of Boston Analytical.
Boston Analytical’s team works with clients to develop and refine the existing methods to meet their testing requirements. The client engagement begins with a consultation process defining user specifications, understanding what the client is trying to characterize, and analyzing the feedback from regulatory agencies. “We then carry out some literature searches looking for technologies that can meet those requirements. One of the things we always ensure is that the services we offer and the work we do is cGMP and 21 CFR compliant,” remarks Heiser. Once the right technology is found and the right level of regulation is achieved, the team moves forward to proof of concept testing. “Not every company out there helps with these additional steps. We work collaboratively with clients to solve all of their analysis and microbiological testing challenges,” explains Heiser.
“When you work with Boston Analytical you’ll receive a dedicated team who will help you establish key goals and opportunities, build effective strategies, achieve a regulatory threshold in order to get to clinical trials quickly, and provide the right mix of services to meet your unique objectives.”
Boston Analytical prides itself on being dedicated to enabling the growth of the pharmaceutical industry that is continually improving in all aspects—efficiency, effectiveness, and profitability. “A lot of the competition in the market is funded by venture capital or the publicly traded companies and they tend to drive to the bottom line, whereas we’re very focused on our clients and our employees and their success,” cites Kristin. “We have the best of both worlds—a cutting-edge facility and we invest all of our profits back into the company.”
Envisioning a Future Rooted in Success
For the year ahead, Boston Analytical plans to continue working hand-in-hand with customers across the pharmaceutical, biopharmaceutical, and medical devices industry to help solve critical project challenges. The firm is also looking forward to seeing the first FDA-approved microbiome-based product hit the market. “We will deliver excellence in our services and increase our capacity to be able to handle the market influx as a result of the first FDA-approved product,” states Mich. On the geographical front, Boston Analytical is considering expanding its services to support clients with their clinical trials across different locations in Europe. “Depending on the market trends and client needs, we will continue to add to our ‘repertoire,’” says Kristin.
Analytical and microbiological testing are critical parts of drug development and manufacturing. The qualitative and quantitative results generated from validated analytical and microbiological testing provide first-hand information to control and ensure the quality and safety of raw materials, intermediates, and finished products. With a partner like Boston Analytical that is at the forefront of providing businesses with the highest quality analytical testing services, the pace of developing and bringing a drug to the market can be accelerated effectively.