February 1, 2015 (Vol. 35, No. 3)

Core Competencies in Complex Biologics and Biosimilars Position CRO for R&D Turnaround

As a contract research organization (CRO) with expertise in two fields of widespread interest—the characterization of complex biologics and the development of biosimilars—Blue Stream Laboratories does not lack for opportunity. To realize its promise, the company is strategically reinforcing its core competencies while capturing the economic benefits of outsourcing. These actions have helped Blue Stream achieve double-digit growth in the past year, increase staff by one-third, and double its lab and office space.

“We provide analytical laboratory services to help solve complex problems, so many of our clients come to us when they have nowhere else to turn,” says Michael Kouchakdjian, Ph.D., president of Blue Stream. Those services include fine structural characterization programs as well as method development, qualification, validation, cGMP release, and stability testing for biosimilars and non-biosimilars, and take molecules from post-discovery through the late-stage clinical phases.

The company has special expertise in testing recombinant proteins—in particular, the challenging areas of highly glycosylated glycoproteins. “The products our clients are developing are complex biologicals with post-translational modifications,” says Dr. Kouchakdjian. “The glycan structures are critical, but fully characterizing them is difficult.”

New Facilities, More Instruments

“Early in drug development, you want quick results using preliminary data,” asserts Dr. Kouchakdjian. So, when Blue Stream recently expanded its facilities to 14,000 square feet, the CRO took the opportunity to separate its GMP and non-GMP services into separate laboratories to provide more focus and efficiency for each category of service.

The non-GMP lab handles projects that need results that are fast and cost-effective, to help determine whether to proceed to the next stage of development. Later, once programs advance to the point where more rigorous, controlled testing is required, separate GMP facilities provide the testing conditions prescribed by regulatory bodies. The company has passed audits by the FDA and by Qualified Persons for EMA standards compliance.

Blue Stream is organized into three separate laboratories. “The largest is our analytical characterization unit,” Dr. Kouchakdjian points out. Mass spectrometry and biophysical characterization are the other two, enabling orthogonal testing to confirm a molecule’s structural and formulation/stability characteristics.

“We have five mass spectrometers of various types, which provide versatility in the services that we provide,” he adds. The biophysical characterization unit recently added three new instruments: a surface plasmon resonance instrument to measure binding and affinity, a circular dichroism instrument to help determine secondary structure of biomolecules, and a differential scanning calorimeter to measure folding and stability of proteins.

Blue Stream provides both package solutions for a program—such as characterizing molecules using many methods—and also provides a la carte services for clients that need to quickly test a compound using a specific method.

Blue Stream is actually organized into three separate laboratories. The largest is the analytical characterization unit. Mass spectrometry and biophysical characterization are the other two, enabling orthogonal testing to confirm a molecule’s structural and formulation/stability characteristics.

Expertise on Tap

Based near Boston, MA, Blue Stream is well situated to attend cutting-edge scientific meetings and to tap the expertise of some of the world’s premier scientific institutions.

“We have close relationships with the people at those institutions,” Dr. Kouchakdjian emphasizes. Those relationships provide Blue Stream with surge capacity as experts come on board as consultants or contractors for specific projects that require unique or advanced expertise. Some eventually join Blue Stream full-time as employees.

International Clientele

Blue Stream’s combination of services and the breadth of available expertise attracts customers throughout the world, Dr. Kouchakdjian says. The opportunity in Asia, he continues, “has to do, especially, with the need for biosimilars testing,” given that many of the company’s clients in the region are developing biosimilars.

Communications is one of the greatest challenges with international research. “With our New England clients, we can have face-to-face meetings easily. Internationally, we rely on email messages and phone and e-conferences,” says Dr. Kouchakdjian. “We make an effort to overcommunicate and to use the resources of our employees who came from overseas.” This commitment to keeping such geographically diverse participants “in the loop” helps Blue Stream cultivate researchers who are fluent in the clients’ languages as well as English.

Growth of Outsourcing

At least a part of Blue Stream’s growth was possible because the biotech and pharmaceuticals industries have embraced outsourcing. Blue Stream serves clients of all sizes, from virtual biotech firms to large pharmaceutical organizations in North America, Europe, and Asia.

Initially, companies considered outsourcing because they needed to streamline operations and downsize, but then, Dr. Kouchakdjian explains, companies “realized it helped them become faster, more productive, and more cost-efficient.”

Outsourcing analytical programs to a specialty CRO not only adds deep expertise in certain areas that even large pharmas may lack, it also brings a certain nimbleness and flexibility. Furthermore, says Dr. Kouchakdjian, outsourcing as a fee-for-service allows companies to convert fixed costs to variable costs, thus helping them stretch their budgets.

Outsourcing is also convenient. Sometimes it’s simply easier to outsource than to tackle a project internally, particularly when many projects are underway and internal capacity may be strained.

CROs are benefitting from the turnaround in the biotech industry, too. “Things have been tough for the biotech industry since the 2008 recession,” admits Dr. Kouchakdjian. “But the industry is roaring back with the opening of the IPO window the last few years.” While that window was closed, smaller companies scaled back R&D and focused on fewer projects to conserve capital. Now, insists Dr. Kouchakdjian, those companies are beginning to advance multiple programs again.

Blue Stream Laboratories

Location: 8 Henshaw Street, Woburn, MA 01801

Phone: (617) 234-0001

Website: www.bluestreamlabs.com

Principal: Michael Kouchakdjian, Ph.D., President

Number of Employees: 25

Focus: Blue Stream Laboratories is a contract research organization specializing in recombinant glycoprotein and complex biologics characterization services.  It can support programs from pre-IND to BLA stages.

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