Earlier this week, Evans Analytical Group®, better known as EAG, a global scientific services company offering testing, analysis and characterization to technology- and life-science-related industries, announced that it has combined its 11 corporate brands, including ABC Laboratories, under a new, singular, entity: EAG Laboratories.

Following a number of acquisitions in recent years, the move is designed to bring together broad capabilities in the materials, engineering and life sciences sectors. The new company expects to leverage scientific talent in its 20 locations in the United States, Europe and Asia-Pacific regions, strengthening its offering for industries including pharmaceutical, biopharmaceutical, medical devices, crop protection, aerospace, defense, semiconductor, wearables (and other consumer products), among others.

“Over the last decade, EAG Laboratories has quietly added capabilities through complementary acquisitions and service line expansions in the high-growth contract research and testing space,” explained Siddhartha Kadia, PhD, president and CEO of EAG Laboratories.

Following the discovery of a potential therapeutic drug or biologic, regulatory agencies around the world are requiring an increasingly complex and demanding process of pre-clinical and clinical trials. A large part of this development process is required to demonstrate drug safety and therapeutic efficacy.

“We’ve built a problem-solving culture in which our scientists and engineers go beyond simply delivering data. Our scientists interpret results and find answers that support our clients’ commercial success. That is something today’s technology-driven companies need from their outsourcing partners, and it makes EAG unique in the scientific services arena. By unifying multidisciplinary expertise under one brand, we simplify delivery of our services to enhance our customer relationships,” Kadia further noted.

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Siddhartha C. Kadia joined EAG as President and Chief Executive Officer in April, 2014.
Photo 1.0: Siddhartha C. Kadia, PhD, joined EAG as President and Chief Executive Officer in April, 2014. Courtesy: © 2016 EAG Laboratories. Used with permission.

“With our unique, multidisciplinary, expertise in the life-, materials- and engineering-sciences, we help our clients innovate and improve their products, ensure quality and safety, protect intellectual property and comply with the ever evolving global regulatory demands,” Kadia added.

ABC Laboratories
One of the original EAG companies, ABC Laboratories (Columbia, MO), a GLP and cGMP-compliant Contract Research Organization (CRO), established 1968 and acquired by EAG in 2015, offers a range of product development, structural characterization, analytical testing, custom synthesis and radio-labeling services, as well as testing capabilities for small- and large-molecules.

Drug development
Following the discovery of a potential therapeutic drug or biologic, regulatory agencies around the world are requiring an increasingly complex and demanding process of pre-clinical and clinical trials. A large part of this development process is required to demonstrate drug safety and therapeutic efficacy.[1]

With a large number of antibody-drug conjugates (ADCs) in development, companies require extensive characterization and analytical services in order for a novel (ADC) drug candidate to enter a clinical trail. Because of the relatively low odds of success in the development of novel therapeutic agents and the large investments required, biotechnology companies are generally focusing on potential therapies with the highest likelihood of generating commercial success. [1]

This is where EAG Laboratories plays a role.

“We have a thorough knowledge of the regulatory landscape in a various global jurisdictions as well product-specific knowledge and understanding of the (clinical) drug development process,” explained Glenn Petrie, PhD, EAG Laboratories’ Senior Scientific Advisor. “This gives us the unique opportunity to support our clients’ and help them find specific answers and, ultimately, help them reach commercial succes,” he added.

Characterization and analysis
The physico-chemical properties influencing the safety and therapeutic efficacy of novel biologics are their Critical Quality Attributes or CQAs. For therapeutic monoclonal antibodies there is an increasing number of studies explaining which attributes are really critical.

Because conjugation methods can influence heterogeneity, and therefore impact the pharmacokinetic, safety and therapeutic efficacy of an ADC, the Critical Quality Attributes for ADCs may overlap those of the monoclonal antibody intermediate, while others involve size variants (aggregates and fragments), drug distribution, average drug-to-antibody ration or DAR, and free drug level.

Other Critical Quality Attributes may include charged variants associated with the monoclonal antibodies, as well as process impurities such as those related to the cytotoxic anti-cancer drug, the linker chemistry, conjugation and product isoforms. Each of these Critical Quality Attributes can be used during the development of antibody-drug conjugates to demonstrate that a manufacturing process can reproducibly meet defined criteria.

“Using state-of-the art instrumentation and a pioneer approach to methodologies, we’re a highly technical, experienced and innovative partner for companies seeking characterization and analytical services for their antibody-drug conjugates development tracts,” Petrie noted.

“The combination of analytical as well as process knowledge, helps us to support our clients develop antibody-drug conjugates with consistent quality, safety, and therapeutic efficacy for both clinical and commercial use,” Petrie added.

Small and large
“While we work for a large number of biotechnology companies involved in the development of antibody-drug conjugates, some of our smaller clients may involve ‘virtual’ companies. These clients may be working with Contract (Development) Manufacturing Organization (CDMO), but they don’t have their own (production) facilities or laboratories. Others may have an extensive infrastructure. But overal, our clients tell us that while they may have a great relationship with their CDMO, given the complex supply chain involving multiple partners, each with their own, specific, expertise, they prefer outsourcing characterization and analysis to us,” Petrie concluded.

Pursuing a vision
In 2008 Odyssey Investment Partners acquired EAG Laboratories.

“Since [the] acquisition, we have been following an aggressive strategy in adding some of the world’s most trusted names in contract research, development and testing. While the puzzle is not yet complete, our clients see us as  a global scientific services company with industry-leading expertise in testing, analysis and characterization services, bringing significant customer value to multiple markets,” Kadia said.

“Since day one, we’ve pursued our vision of being a world-class testing and analytical services company by adding more and more expertise and capability to a company we believed to have the best and brightest people in the industry,” added Randy Paulson, a managing principal at Odyssey Investment Partners, EAG Laboratories’ majority owner.

“We now have expanded services that match all our clients’ testing and analysis requirements, and also have been aggressive in augmenting our executive team in the last 18 months. We have all of the pieces in place to help grow EAG Laboratories, creating even more value for our worldwide customer base,” he concluded.

The new company employs 1,200+ employees across 20 laboratories in seven countries, serving more than 7,000 clients worldwide.

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