1. As the pharmaceutical industry grows and becomes more complex, what services, in general, are most needed by companies to safely and efficiently move products through the development pipeline to bring new products to market?
Drug discovery and development is a high-risk and costly process requiring specific and sophisticated expertise at every step. Not only is the industry itself becoming more complex, but the products being developed are advancing as there is more discovery and development focused on Biologics such as Gene Therapies, monoclonal antibodies, Antibody Drug Conjugates, and other recombinant proteins. These Biopharmaceuticals, in particular, require sophisticated structural, physicochemical, biophysical, and protein characterization using state-of-the-art instrumentation to successfully perform to regulatory standards. Companies developing these therapeutics require focused, knowledgeable scientific expertise in an analytical lab partner. The lab partner must be able to support testing for the safety, potency, efficacy, and stability of their pipeline as well as their established products. Efficiency and speed to market are accomplished when the analytical testing is completed accurately and within designated timeframes, which in turn can only be accomplished with industry and scientific experience coupled with appropriate technology. As a leading analytical laboratory, SGS partners with pharmaceutical and biopharmaceutical clients to focus on core competencies, improve overall performance, and minimize costs.
2. How do service providers such as SGS ensure that they are providing the highest quality services to their customers?
The services SGS provides to pharmaceutical and biopharmaceutical companies are essentially an extension of our clients’ Quality departments. We have a robust Quality Management System (QMS) that is consistent across our global network labs. The establishment and maintenance of a global QMS allows us to provide customers with accurate, timely, and reliable results. The QMS governs policies and procedures in our analytical laboratory network to ensure compliance with regulatory agencies in all major markets. We ensure high-level, quality service is being provided with extensive internal quality audits that are treated just as a regulatory audit would be. The quality of our service offerings is further enhanced by any actions taken after a client-run audit, which is being conducted on any given week in one of our laboratories.
The results of the emphasis we put on quality are demonstrated by our recent 2023 CRO Leadership Award which is determined by Industry Standard Research’s annual CRO Quality Benchmarking survey. SGS was recognized for meeting or exceeding customer expectations in all five categories measured—Capabilities, Compatibility, Quality, Reliability, and Expertise.
3. Can you give us an overview of the tools and technologies you employ at your facilities to provide the best possible services to your clients?
Within our laboratory network across North America, SGS operates hundreds of different technologies and platforms to deliver a comprehensive offering of QC testing across Microbiology, Chemistry, and Biologics disciplines to support raw materials, APIs, and finished products.
We continue to evaluate and expand our service offering to meet our clients’ evolving needs. For example, to support our client’s growing needs for Biologics testing, we continue to make investments at our two Biologics centers of excellence located in the US and Canada.
We are expanding our Biologics Center of Excellence located in the Chicago Metropolitan area by adding a number of technologies such as Analytical Ultracentrifugation, Mass Spectrometers, Gas Chromatography, and Protein Sequencers to name a few. We have also recruited top talent in the field of higher-order structure analysis, Mass Spectrometry, and Biophysical Characterization to supplement our team of experts in Immunoassays and Cell Line Characterization. This expansion will triple our capacity for Biologics testing at the site and also bring new services including Biophysical and Mass Spec analysis of proteins.
We also continue to expand and add to our innovative technologies at our Mississauga, CA site, with the additions of Sanger Sequencing, ddPCR, and genotyping technologies to accommodate industry demand and requests from clients. These technologies enable us to perform fast, accurate, and comprehensive analysis of DNA samples for Drug Development.
The enhancements at these two sites strengthen our focus on supporting end-to-end drug development support services for large molecules giving clients the additional capacity and innovative solutions they need. Importantly, both laboratories can support the growing Biosimilars industry. Our subject matter experts work directly with customers developing Biosimilars to design and execute comparability testing.
We also recently announced a partnership with Australia-based company, Agilex Biolabs, which will strengthen our ability to support Bioanalytical Testing, primarily for small molecule drug candidates in Phase 2 and 3 clinical trials. We are actively adding and qualifying advanced LC-MS/MS platforms in our Boston region site and expanding our staff to support bioanalytical study design and execution.
In 2024, we will continue our push through Digital Transformation with the launch of our new Customer Portal and the expansion of our Project Management tools. Both of these tools will provide our customers with a more seamless, efficient, and digitally connected experience.
4. Looking ahead, how will SGS ensure it remains at the forefront of analytical technologies and continues to provide must-needed services for its current and future clients?
The SGS Drug Development team stays at the forefront of technology and services through active engagement in scientific conferences and with regulatory bodies. SGS also has established executive sponsorship programs with critical vendors which allow us to gain visibility into new technologies. We also remain laser-focused on operational excellence, which we do through the implementation and utilization of our corporate World Class Services program. We continue to embrace transformation on the digital front through improved connectivity for our customers and through the exploration of using AI to support the Drug Development process. Finally, we continue to grow and manage our laboratory network with Sustainability as a critical factor. Both SGS and our customers are committed to meeting Sustainability goals and through our partnerships we will be able to support growth well into the future.
Publication Detail
This article appeared in American Pharmaceutical Review:Vol. 27, No. 1Jan/FebPages: 34-35
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