Solvias USA, Inc.

Solvias USA, Inc. is the North American arm of Solvias AG, a global cGMP contract research organization (CRO) headquartered near Basel, Switzerland, with more than 25 years of experience as a premier provider of chemistry, manufacturing, and control (CMC) analytics. The organization operates two Centers of Excellence in the United States — a well-established pharmaceutical and analytical laboratory in Canton, Massachusetts (formerly Chemic Laboratories, Inc., acquired by Solvias in 2021), and a purpose-built 50,000-square-foot biologics and cell and gene therapy testing facility in Research Triangle Park (RTP), North Carolina, which entered operations in 2025. Together, these facilities support a global client base of over 650 pharmaceutical, biotechnology, ATMP, medical device, and cosmetics companies at every stage of product development, from early-stage candidate characterization through regulatory submission and commercial batch release.

Solvias USA's core CMC analytical portfolio is broad and deeply integrated. Services include cGMP drug substance and drug product testing and release, analytical method development and validation, characterization and comparability studies, biosimilar analytics, raw material testing, residual solvent determination, cleaning validation, and long-term stability program management. The organization is equally equipped for small-molecule APIs and large-molecule biologics. Analytical instrumentation spans high-performance liquid chromatography (HPLC), liquid chromatography with tandem mass spectrometry (LC-MS/MS), gas chromatography-mass spectrometry (GC-MS), nuclear magnetic resonance (NMR) spectroscopy, and inductively coupled plasma mass spectrometry and optical emission spectrometry (ICP-MS and ICP-OES), providing the breadth needed to cover identity, potency, purity, impurity, and elemental characterization across diverse drug modalities.

Pharmaceutical impurity testing and contamination control represent a particular area of strength within the Solvias USA service offering. The laboratories provide extractables and leachables (E&L) analysis in compliance with ISO 10993 and BPOG/ELSIE guidance, genotoxic impurity screening and control method development under ICH M7, and rapid nitrosamine impurity analysis — including NDMA, NDEA, NMBA, NDIPA, nitrosamine drug substance-related impurities (NDSRIs), and other small nitrosamines — using validated LC-MS/MS and GC-MS methods. Elemental impurity testing adheres to ICH Q3D requirements and USP compendial chapters, ensuring sponsor submissions meet current FDA and EMA expectations. Pharmacopeial testing is conducted across USP, EP, and JP monograph frameworks, supporting global drug registration programs.

Microbiological and biological testing services complement the chemistry platform and span sterility testing, microbial limits and bioburden determinations, endotoxin and pyrogen testing, antimicrobial effectiveness testing (AET), and cell-based potency assays. These capabilities are available in full cGMP compliance for the release of both sterile and non-sterile medicinal products. The Hombourg, France Center of Excellence contributes additional molecular biology, cell-based bioassay, and microbiology capabilities that are part of the integrated global Solvias portfolio, allowing North American clients to access the full breadth of the network's biological testing infrastructure for programs with international scope.

The Research Triangle Park Center of Excellence is Solvias's flagship site for large-molecule and advanced therapy analytics in North America. The facility is designed specifically to support biologics, cell therapies, and gene therapy programs, offering cGMP release and characterization testing for adeno-associated virus (AAV) vectors, messenger RNA (mRNA) therapeutics, and antibody-drug conjugates (ADCs). Critical cell-based potency assays and next-generation sequencing (NGS) capabilities are central to the RTP service offering, providing clients in the rapidly evolving ATMP sector with the scientific infrastructure necessary to meet FDA Biologics License Application (BLA) and Investigational New Drug (IND) submission requirements. The facility was planned to employ approximately 200 scientists and support staff over three years, reflecting Solvias's long-term commitment to the North American biologics market.

The Canton, Massachusetts laboratory provides a complementary base of pharmaceutical chemistry, analytical testing, and E&L services. Situated at 480 Neponset Street, Canton, this facility serves pharmaceutical, biotech, and medical device clients with method development and validation projects, stability studies under ICH climatic conditions, batch release testing, and container closure system analyses. Its location within the densely populated Boston-Cambridge life sciences corridor makes it a convenient analytical partner for both emerging biotechnology companies and large pharmaceutical sponsors with regional operations, and the site has maintained the strong client relationships Chemic Laboratories built over decades as a trusted Northeast contract laboratory.

Solvias USA operates within an integrated quality management system that meets FDA cGMP requirements (21 CFR Parts 210/211 and Part 11 for electronic records), GLP standards, and ISO 17025 accreditation across the Solvias network's Centers of Excellence. The quality system is regularly inspected by the FDA, Swissmedic, and the French ANSM, and holds ISO 9001:2015 certification. These multiple layers of regulatory oversight provide clients with high confidence in data integrity, audit readiness, and the suitability of Solvias-generated data for inclusion in dossiers submitted to the FDA, EMA, and other global health authorities, making Solvias USA a credible and audit-ready analytical partner for life sciences clients seeking CMC support at any stage of the product lifecycle.