SGS: Innovating for biotech partners

AS THE GLOBAL LEADER IN THE TESTING, INSPECTION AND CERTIFICATION

INDUSTRY, SGS helps pharmaceutical and biotech companies navigate the regulatory landscape, providing comprehensive testing solutions that help clients get their products approved and released to market faster.

In the middle of the pandemic — a time when biotech companies were already struggling to meet turnaround times and supply chains were either strained or completely decimated —companies turned to SGS for help.

Of note, a gene therapy company needed to quickly validate assays for its flagship mRNA drug candidate to meet the filing deadlines for its first investigational new drug application (IND).

SGS, which prides itself on its ability to respond quickly and effectively to client requests, completed the development and validation of nine assays, including the critical potency and purity assays, in time for the IND filing deadlines and received thanks from the client’s principals, who said the achievement of this milestone would not have been possible without SGS.

For this job, SGS had the right equipment, expertise and project management team to set goals and timelines and was able to complete the work at its labs in Mississauga. The company’s leadership highlighted that open and honest communication was key to the success of the project because it allowed for a true partnership.

The client described SGS as “easy to work with, receptive to feedback and very effective.” A tangible vote of confidence came when that client returned to SGS for its stability studies, assay development and qualification for follow-on products.

SAFE AND EFFECTIVE TREATMENTS

As the above example shows, in the journey to bring safe and effective treatments to market, pharmaceutical and biopharmaceutical companies face many challenges, ranging from shorter product lifecycles, competitive

pricing, technological advancements that drive changes across the industry and intricate and rigorous quality standards. Then there is the complex regulatory landscape that companies must navigate to ensure proper testing is completed each step of the way.

Few companies can complete the full scope of drug development in-house and must turn to contract laboratories to support them. SGS has met and conquered some of the most complex formulation, analytical and manufacturing challenges faced by clients in the industry today.

“To meet those challenges, SGS is always investing in building innovative platforms and a strong multidisciplinary team that offers expertise in everything from physicochemical and biological chemistry to molecular biology, cellular biology and microbiology,” says Dr. Niveen Mulholland, vice president of health science and drug development for SGS North America. “Our clients need their testing services done fast, with exceptional quality assurance and we are here to support them.”

With vast experience and comprehensive testing solutions, SGS is single-solution partner for companies that need help jumping through regulatory hurdles to realize important medical discoveries — whether vaccines, gene therapies or pharmaceuticals — and get them one step closer to market and into the hands of patients. In the end, saving lives and improving quality of life are the goals of all of SGS’s partnerships.

“Clients entrust us to provide support for their lifesaving products,” Dr. Mulholland says. “They rely on our specialized testing expertise to ensure the highest level of quality and safety for patients. With more than four decades of unparalleled experience, we have mastered the art of adaptation and pivoting to meet industry needs.”

CANADIAN OPERATIONS

In addition to three laboratory locations in the U.S., SGS has two additional GMP-certified facilities in Markham and Mississauga, CA. Their core capabilities are in microbiology, chemistry, and biologics testing, and the facilities operate in two shifts, allowing SGS to provide enhanced testing capacity.

“We ensure harmonized services between these locations,” says Dr. Ida Dossou, general manager of SGS’s Mississauga facility, “and we deliver consistent, highquality testing with seamless support to meet strict deadlines and ever-increasing throughput demands.”

SGS makes quality and safety priorities as clients rely on the company to support them from the early stages of molecule development to successfully reaching the market.

“This is not just our goal; it’s our purpose,” Dr. Dossou adds.

Given the rise of RNA-based therapeutics, SGS is now actively working to bridge gaps when it comes to client’s bioanalytical and genomic needs.

As a step towards this goal, SGS is expanding its sequencing capabilities in North America. Sanger sequencing, for example, is a valuable tool in RNA-based gene therapies. Though initially developed for DNA sequencing, its application has been extended to the analysis of RNA molecules, including messenger RNA (mRNA) used in gene therapies. This type of sequencing enables companies to validate the accuracy and integrity of the modified mRNA sequences, ensuring the desired genetic changes have been successfully incorporated. By confirming the correct sequence, SGS can verify the safety and efficacy of RNA-based gene therapies, contributing to the development of more precise and targeted treatments for many genetic disorders and diseases. Additionally, SGS is in the process of adding rapid-sterility testing to support growing demand for this service.

“To meet those challenges, SGS is always investing in building innovative platforms and a strong multidisciplinary team that offers expertise in everything from physicochemical and biological chemistry to molecular biology, cellular biology and microbiology”

BUILDING TOMORROW’S INFRASTRUCTURE TODAY

SGS’s Mississauga facility is mobilizing new technologies for DNA and RNA analysis. DNA and RNA are the building blocks of life and their analysis is essential for understanding the molecular mechanisms of various biological processes and diseases.

To that end, SGS is working to build new RNA sequencing platforms, especially for single-cell RNA sequencing and spatial transcriptome sequencing. Expected to be ready next year, that initiative will include ddPCR, a technique that can quantify the absolute amount of DNA or RNA molecules in a sample without needing a standard curve or reference material. ddPCR can also detect rare mutations or variants and measure gene expression levels or copy number variations. It’s an invaluable tool in several areas, including gene expression analysis and quality control of modified cells, among others.

The company is also adopting new technologies in cancer research, infectious disease diagnosis, gene therapy and synthetic biology. Meanwhile, a primary area of focus for SGS is analytical development and validation, to provide product characterization analytics and GMP release and stability testing for cell and gene therapies.

ATMPs require complex methods to ensure their safety, identity, purity, strength and potency and SGS offers a comprehensive range of methods built on innovative platforms to support raw material testing, cell culture media analysis, oligonucleotide analysis, process-related impurities, product characterization, product-release and stability analysis and container closure testing.

“The implementation of Sanger Sequencing and ddPCR platforms are two exciting additions to our powerful arsenal supporting highdemand cell and gene therapies,” Dr. Mulholland says. “SGS is committed to being future-ready and has a string of investments in the pipeline.”

As a leading contract service organization supporting all phases of drug development, SGS continues to focus its service offering on the needs of the industry. Whether it’s investing in new technologies, expanding capacity for highdemand services or using state-of-the-art instrumentation in new ways, SGS continues to invest in enhancements to support its clients in providing better, safer treatments to patients.

“Whether you need a partner to support you through every stage of the drug development cycle or just need an extra hand when your in-house capabilities are restricted, SGS is flexible to meet the industry’s testing needs, “mentions Dr. Mulholland. “We are here, and we are ready to support your goals of improving quality of life and saving lives.”