EXECUTIVE INTERVIEW - SGS Life Science Services: Getting Medicines to Market Quickly & Safely

With 29 facilities in 15 countries, SGS Life Science Services represents the broadest wholly owned global network of contract analytical laboratories. SGS has been providing clinical research, analytical development, biologics characterization, biosafety, and quality control testing for over 35 years to the pharmaceutical, biologics, and medical device industries. SGS offers GMP/GLP contract laboratory services that include analytical chemistry, microbiology, stability studies, bioanalysis, extractables and leachables, virology, cell bank and virus seeds characterization, and protein analysis. The company also provides Phase I-IV clinical trial management and services encompassing bioanalytical testing, data management, biostatistics, and regulatory consultancy. Mark Rogers, PhD, Senior Vice President Life Science Services at SGS, recently spoke with Drug Development & Delivery to discuss his company’s evolutionary development and the trends it is witnessing in the analytical testing market.

Q: Can you provide some background on SGS, specifically what services are offered in North America?

A: The SGS Life Science division in North America comprises a network of five laboratories – Lincolnshire, IL, Fairfield, NJ, West Chester, PA, Mississauga, ON, and Carson, CA. Certain service activities, such as microbiology, are replicated in most of the sites allowing for high capacity and mitigation of risk. Others are specific and are performed at a single laboratory but are nevertheless offered throughout the network. The scope of testing ranges from routine, compendial methods to research and development and covers a broad variety of compound types from large to small molecules.

Q: How has the testing industry changed throughout the years for SGS?

A: The product development pipeline of the pharmaceutical industry has traditionally been small molecules; however, through the years, there has been a shift toward a greater portion of the pipeline being in biopharmaceuticals. SGS realized this, and thus, in 2006, opened a laboratory in Wavre, Belgium to develop biologics testing. In 2010, SGS completed its acquisition of the MScan group, specializing in biologics characterization and has since developed specific, large molecule testing services in a number of the existing, traditionally small molecule, SGS laboratories. Earlier in 2014, SGS also introduced new services for the preformulation and stability testing of biologic products.

Q: What are some of the biggest challenges in the testing industry?

A: As in any business, there are challenges that are unique to the specific industry and those that are common to all. In the field of Life Science testing, responsiveness in terms of capacity and capability are a concern. For instance, a client may have an unexpected and immediate need for a unique test or expertise with which a contractor may have only limited experience. Therefore, as a service provider, we must anticipate the needs the industry may have and maintain the necessary expertise that can be developed to meet customer requests and potential regulatory requirements. For example, as part of the new preformulation and stability services, SGS is able to design and execute shipment excursion studies involving risk-based design using automated temperature and humidity cycling. Data from these studies can also be used to support formulation, forced degradation, and stability studies. Additionally, maintaining the same level of service relationship with both large and small clients, who often have very different demands on the service, is also a challenge in terms of business development and management strategies. Finally, combining strong growth while preserving quality is often difficult but essential in this heavily regulated industry.

Q: How is SGS uniquely qualified and able to address these challenges?

A: The operational challenges, such as those involving rapid changes in demand for capability or capacity, are very well addressed within SGS by utilization of the Life Science Services laboratory network. Sudden, often short-term demands for increased business are moderated by the ability to allocate the work to more than one site. Business development is structured in a way that successfully manages a broad range of clients and their needs by layered teams of specialists that are able to work collaboratively on local, regional, and global levels. Within SGS, significant emphasis is placed on quality. This attribute is recognized as critical throughout all aspects of the network and, under leadership from the business managers, is assured despite the pressures often encountered during strong growth.

Q: You recently had a press release on an investment in a new laboratory in California. What is the significance of this new laboratory for SGS?

A: The laboratory in California provides SGS with a presence on the West coast in a region of significance for pharmaceutical and biopharmaceutical testing services. This new laboratory will expand the current capabilities of SGS, offering bioanalytical testing, which is currently only performed in our European laboratories. While the bioanalytical services will be new to North America, we will be able to leverage the expertise from our sites in Poitiers, France, and Wavre, Belgium, where SGS has over 700 validated methods to date. Furthermore, the microbiological aspect of the California service offering provides a local presence to those clients who require a very rapid sample processing time. In this instance, the geographic proximity will certainly be a benefit to the clients.

Q: What makes SGS unique as an outsourcing partner?

A: SGS Life Science Services offers a truly integrated network of laboratories able to respond very quickly to the changing demands of the testing market. The network is a seamless organization, providing clients access to unparalleled expertise in a broad range of technical areas. The scope of services, from high throughput routine tests to in-depth development and validation, requires different business strategies, readily applicable in a network, such as SGS, and providing the client with ideal execution of their particular testing needs.

Q: Where do you foresee the industry heading, and how is SGS poised to handle emerging needs?

A: There is little doubt that the most significant change in the Life Science testing market is being led by the re-focus of traditionally small molecule manufacturers and pharmaceutical companies to the area of large molecule therapeutics. By virtue of the complexity of these biological entities, this is particularly demanding for businesses in the testing market due to the number and sophistication of new and unique services required to satisfy the analytical and regulatory requirements of the large molecule sector. SGS has adapted quickly to these needs by strategic investment within its existing laboratories and by acquisition. More specifically, the increasing pressure for biosimilar development and manufacture in the US will inevitably result in a surge of demand for testing of such molecules. SGS has already taken measures to develop analytical platform methods to address such a challenge and a marketing campaign to raise the profile of SGS in these services.

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