7 minute read
SGS
Niveen Mulholland (Ph.D.), Vice President of Health Science Drug Development for SGS North America, tells us how SGS is supporting the Biotech industry in Canada.
WHY ARE PHARMACEUTICAL AND BIOPHARMACEUTICAL COMPANIES CHOOSING SGS FOR TESTING AND SUPPORT THROUGH DEVELOPMENT AND DELIVERY OF THEIR DRUG PRODUCTS?
The short answer is quality. In order to bring safe, effective treatments to market, our clients must pass complex and stringent quality standards along the way. SGS is the benchmark for safety and assurance in a space where expectations are on the rise to meet with the changes and demands of the regulatory landscape. Our clients provide life-saving products to the world and they rely on our specialized testing expertise to support them throughout their journey to market, ensuring the highest level of quality and safety for patients. Decades of unparalleled expertise has allowed us to facilitate this journey. That kind of longevity means we’ve learned to adapt and pivot as industry needs expand.
With nearly 6,000 square metres and more than 350 employees, our state of the art, GMP certified facilities in Markham and Mississauga are well positioned to meet the needs of our clients with core capabilities in Microbiology, Chemistry and Biologics testing. Operating in two shifts, these facilities permit us the kind of enhanced testing capacity that our customers require. Harmonized services between these two locations means we deliver consistent, high-quality testing with seamless support, allowing us to address ever increasing throughput demands on a rushed timeframe.
Most importantly, our clients are ensured accuracy and precision every step of the way. Our firm grasp on the crucial role we play in today’s market means that quality and safety are not only intrinsic to our process, but also to our priorities. Our clients depend on us to support them from molecule to market. This isn’t just our goal, it’s our raison d’être.
WHAT ARE YOUR CORE CAPABILITIES?
SGS supports clients from discovery to clinical development and commercialization to deliver high-quality, safe, and effective medicines to market. Our diverse range of solutions matches our clients’ biologics and small molecule development needs, helping them navigate complex worldwide regulatory requirements.
We offer comprehensive solutions ranging from method development and validation and QC testing to final release and stability studies.
With solid expertise on development and phase-specific validation of methods we can evaluate the identity, potency and purity of drug products, APIs, and degradation products. We offer QC testing for raw materials, excipients, APIs, and finished products through our expertise in Analytical Chemistry, E&L Study Design, Microbiology and Biologics testing.
Performing QC release testing services to ascertain the identity, purity, potency and safety of the product means we can support long term or accelerated stability studies for all ICH conditions, as well as specific conditions, in our fully controlled chambers validated with 24/7 monitoring and alert system.
We have experience in qualification of client provided (in-house) reference standards as per ICH guideline and can manage storage in our fully controlled chambers validated with 24/7 monitoring and alert system.
HOW DOES SGS KEEP UP WITH TECHNOLOGICAL ADVANCEMENTS AND CHANGES IN THE PHARMACEUTICAL AND BIOPHARMACEUTICAL INDUSTRY?
Scientific expertise and innovation are the foundations of our growth. We’ve assembled an incredible group of top tier professionals through talent pipelines like internship programs with Guelph and Waterloo Universities. Our diverse workforce is made up of a pool of PHD, MSc., and BSc. level professional and is a well-established platform for learning. This translates to growth and expansion not only in our teams but also in our capabilities. Our specialists are multifaceted, providing best in class analysis in an environment where innovation is key.
Our analytical expertise and state-of-the-art infrastructure enable us to conduct testing for Cell and Gene Therapy (C>) products in a regulated environment. Our C> analytical arsenal includes compendial assays,
identity assays including Sanger sequencing and oligonucleotide sequencing by mass spectrometry, assays for product purity including methods for determining product- and process-related impurities, testing for biosafety, and cell-based and in vitro assays for determining potency. In addition to these, we have specific capabilities to quantitate lipid content in lipo-nano particles (LNP), assess residual process related components such as polysorbates, polyethylene amine (PEI), and have demonstrated experience on quantification of excipients such as poloxamers, polysorbates etc. We have a wellestablished panel of tests that can assess critical quality attributes of Oligonucleotides derived drug substances and drug products. We play a crucial role for our clients that are advancing newer and complex therapies. We are committed to being the market leader for C> based analytical services.
Another area of innovation for us is Droplet Digital PCR (ddPCR). This is a method for performing digital PCR that is based on water-oil emulsion droplet technology. It is one of the most sensitive, precise, and accurate methods for amplifying and absolute quantifying nucleic acids target sequences. At SGS, we have successfully applied this technology for determination of viral genome titer in support of specific projects, taking advantage of its capability to accurate quantitate very low copy numbers, in complex matrices to successfully identify subtle changes in target levels undetectable by real-time PCR. We are also expanding the use of this method to applications such as gene expression levels, mutation detection of single nucleotide variants to discriminate closely related viral strains and copy number variation (CNV) determination.
Expansion of our preclinical in vitro toxicological GLP program is also exciting for us. These studies are an essential part of drug development as they help to evaluate the potential safety and toxicity of a drug candidate before it is tested in human clinical trials. They play a pivotal role in identifying the appropriate dose range for a drug candidate and can provide information about potential side effects and adverse reactions. These studies help determine the potential risks and benefits of a drug candidate and can provide a basis for regulatory approval.
Testing for N-nitrosamine impurities is another area we not only developed but are now expanding. This timely and important test, driven by global regulators and the FDA, is also a Health Canada requirement. Currently, we offer increased capacity for this service with the expertise and technology to identify more than 10 impurities. We also offer a method of Nitrite analysis, which can be helpful to screen the excipients and purified water, ensuring that no Nitrite is present which could prevent generating the Nitrosamine in the future final drug product.
HOW DOES SGS SUPPORT CLIENTS IN FULFILLING THEIR VISIONS?
Whether our clients need a partner to guide them through every stage of the drug development cycle or an extra hand when their in-house capabilities are restricted, SGS is flexible to meet our clients’ testing needs through our comprehensive service offering that supports them from molecule to market.
Our global network consists of more than 20 GMPcertified testing facilities worldwide, including 6 in North America, with vast capacity, instrument redundancy and agile scheduling to meet client turnaround times from anywhere in the world.
SGS has extensive experience delivering multifaceted programs at local and international levels, meeting needs and exceeding the expectations of our clients through timely and transparent communication.
Our customer centric culture allows us to deliver superior service to our clients through our dedicated and experienced Client Service and Project Management teams. With diverse skill sets and qualifications, including significant industry experience, strong technical aptitude and hands-on lab experience, as well as formalized project management (PMP) training, these teams support our clients through every phase of their project working with internal and external stakeholders to ensure timelines and deliverables are met.
