What prompted SGS to establish a specialized bioanalytical testing facility in Hudson, New Hampshire?
SGS established the bioanalytical testing facility in Hudson, NH, as part of its strategic effort to broaden our scope of testing solutions offered in North America, as well as expand our footprint for Bioanalytical testing globally. This new lab integrates seamlessly with our existing bioanalytical testing facilities in France, Belgium, Switzerland, Germany, and Shanghai, all of which operate under SGS Global Quality Standards and unified regulatory frameworks. This ensures compliance with rigorous quality standards and regulatory requirements.
We also felt our location would be ideal for serving Boston’s Biotech Hub, facilitating improved collaboration and local access to industry expertise.
Can you provide an overview of the key bioanalytical services offered at the Hudson facility?
The Hudson facility offers a wide range of bioanalytical services. We provide Pharmacokinetics (PK) and Bioavailability services, including Discovery PK/Bioavailability, with rapid turnaround, as well as non-GLP PK, and GLP Pre-Clinical and Non-Clinical studies, including IND-enabling studies.
We also offer Biomarker Analysis for both soluble and cellular biomarkers, with services spanning discovery, fit-for-purpose non-GLP, and GLP studies.
Our clinical and post-marketing studies are performed under GCP and include post-marketing surveillance and veterinary medicine drug development.
In addition, we can handle a diverse range of compounds, including small molecules, large molecules, peptides, proteins, antibody-drug conjugates (ADCs), and more.
We also offer analytical Services, such as method transfer, development, validation, and assay creation, and a variety of testing services such as bioanalytical sample analysis, immunogenicity testing, cell-based assays, and stability testing.
What unique capabilities or expertise does the Hudson facility bring to SGS’ global bioanalytical testing network?
The Hudson, NH facility enhances SGS’s global bioanalytical testing network by offering advanced capabilities and specialized expertise in several areas.
We offer comprehensive analytical techniques and state-of-the-art technology, including mass spectrometry (LC-MS/MS), immunoanalysis (ELISA, RIA, ECLIA), and cell-based assays. These capabilities support the analysis of a wide variety of compounds, including therapeutic proteins, monoclonal antibodies, and biosimilars.
Our lab employs a hybrid approach combining ligand-binding assays (LBA) with LC-MS/MS, providing robust and versatile bioanalytical solutions, particularly for new biological entities.
With large sample storage and automated sample preparation systems, the Hudson lab can process a high volume of samples quickly and efficiently, delivering rapid results to clients.
Our experts also have significant experience in developing and validating innovative biomarker assays, which is critical for advancing drug development from preclinical to late-stage clinical phases.
How does bioanalytical testing complement SGS’ existing pharmaceutical testing services, and what gaps does it fill in the drug development process?
Bioanalytical testing complements SGS’s existing pharmaceutical testing services and allows us to offer seamless integration of services to our clients.
By integrating bioanalytical testing with other pharmaceutical services such as stability testing, method development, and validation, SGS provides a one-stop solution that streamlines the drug development process, reducing time and costs for pharmaceutical and biopharmaceutical companies.
Bioanalytical testing provides essential data on the absorption, distribution, metabolism, and excretion (ADME) of drugs, which is crucial for understanding their efficacy and safety.
This information helps with designing effective dosing regimens, assessing potential side effects, and understanding a drug’s overall safety profile.
In addition, the immunogenicity testing we provide, including screening, confirmatory, and neutralizing anti-drug antibody assays, are vital for assessing the immune response to biologics and identifying a drug’s potential to trigger an immune response.
The Biomarker Analysis we perform also helps us understand the pharmacodynamic effects of drugs and supports personalized medicine approaches.
Can you explain how the Hudson facility integrates with SGS’ other bioanalytical labs in Europe and Asia to provide global support?
The Hudson, NH facility integrates seamlessly with SGS’s other bioanalytical labs in Europe and Asia through a harmonized global network.
All SGS bioanalytical labs, including the Hudson facility, adhere to SGS’s global quality standards and regulatory guidelines, ensuring consistent and reliable results across different regions. All of our labs operate under a unified quality management system that includes global SOPs and quality handbooks, ensuring that every lab functions under the same rigorous standards.
SGS’s One Vision initiative creates a single, integrated digital network across all labs, enhancing communication, data sharing, and project management. This integration allows clients to receive consistent services and results, regardless of the lab’s location.
What advantages does SGS’ one-stop model for testing services offer to pharmaceutical and biopharmaceutical companies?
SGS’s comprehensive testing solutions offer many advantages to pharmaceutical and biopharmaceutical companies.
SGS provides a full range of services from early-stage discovery through clinical development and post-marketing, all within a single network. This includes bioanalysis, stability testing, method development, and clinical trial support.
The integrated approach reduces the need for multiple vendors, streamlining the testing process and reducing overall costs.
With a centralized management system, our clients benefit from streamlined communication and project coordination, leading to faster turnaround times and fewer administrative burdens.
By utilizing a harmonized global network, SGS ensures consistent quality and regulatory compliance across all testing services, providing peace of mind to clients as they navigate the complex drug development process.
What measures has SGS taken to ensure regulatory compliance and quality standards at the Hudson lab?
At SGS Hudson, we are dedicated to providing top-notch bioanalytical services. We follow strict quality. We follow strict quality standards like GLP, GCP, GMP, ISO 900,1, AND 17025. Our team of experts uses the latest technology and methods to ensure our data is accurate and reliable. We are committed to following FDA guidelines and ICH M10 standards, and our global quality management system guarantees consistent quality across all labs.
Looking ahead, what are SGS’ plans for expanding the Hudson facility’s capabilities or capacity to meet future industry needs?
We have already increased lab space, equipment, and staff at the Hudson facility, and plan to continue expanding these resources to support growing demand.
SGS is continuously investing in new technologies and platforms to enhance its bioanalytical capabilities, particularly in areas such as biomarkers, gene therapy, and CAR-T cell analysis.
We aim to broaden our service offerings at the Hudson facility to include more specialized and innovative testing solutions, ensuring we remain at the forefront of the bioanalytical testing industry.
We will also continue to strengthen the integration of the Hudson facility with our global network, ensuring seamless support for clients worldwide and maintaining high standards of service quality and regulatory compliance.
Author Details
Sujata (Suzzy) Bhavekar, M.S, CSM, Study Director, Bioanalytical- SGS North America
Publication Details
This article appeared in American Pharmaceutical Review: Vol. 27, No. 6Sept/Oct 2024Pages: 84-85
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