Comprehensive cGMP analytical services

Solvias Headquarters and Center of Excellence with a Wide Range of CMC Analytical Services

Located in the Greater Basel Area, our Kaiseraugst site is a growing center for biotech innovation. In addition to housing our European management and administrative teams, it offers comprehensive cGMP analytical services for both biopharmaceuticals and small molecules—including drug substance and drug product testing.

Comprehensive Analytical Expertise for Innovative Therapeutics

Our specialized capabilities in cell-based bioassays, molecular biology, and microbiological testing, are each supported by dedicated lab space, expert teams, and expanding portfolios tailored to today’s advanced therapies.

Cell-Based Bio-assays

Solvias now offers cell-based bioassays (CBBAs) at three global locations: Kaiseraugst, Hombourg, and RTP. Leveraging advanced technologies like mass spectrometry, HPLC, and flow cytometry, we provide customized assay solutions compliant with ICH and USP guidelines. With over 30 validated CBBA assays and 4000+ performed for 40+ clinical-stage drugs, we’re committed to advancing innovative, life-changing therapies.

Antibody-Drug Conjugates

Solvias’ ADC Analytical Services offer full characterization and quality control for antibody-drug conjugates at all development stages. With 10+ years of experience and a brand-new state-of-the-art Tox 4 lab, we provide DAR determination, payload/linker analysis, aggregation, and stability testing using advanced techniques like HIC, SEC, CE-SDS, and LC-MS. Our GMP-compliant services meet global regulatory standards to support efficient, safe ADC development.

Peptide Analytical Services

Solvias’ Peptide Analytical Services support development and quality control of synthetic and recombinant peptides from early research to commercial release. With 20+ years of experience, we offer GMP-compliant services such as purity analysis, sequence confirmation, amino acid mapping, impurity profiling, and stability testing. Using advanced tools like LC-MS, HPLC, and NMR, we deliver data aligned with IND, NDA, and BLA regulatory requirements.

extractables and leachables delivery systems

Extractables & Leachables Testing

Solvias’ Extractables & Leachables (E&L) Testing ensures the safety of drug products, biologics, and medical devices by detecting harmful substances from packaging and delivery systems. With 20+ years of experience and 100+ studies annually, we guide clients through study design, method development, risk assessment, and regulatory compliance. Our expert team uses advanced techniques like GC-MS, LC-MS, and ICP-MS to deliver reliable, GMP-compliant results.

cGMP Drug Substance & Drug Product Testing and Release

Our cGMP Drug Substance & Drug Product Testing ensures the quality, safety, and compliance of pharmaceutical products throughout development. We support 2,000+ GMP batch releases annually with comprehensive testing of APIs and biologics, excipients, and finished products for identity, purity, potency, stability, and microbial limits. Our expertise in method validation and global standards (ICH, USP, EP) enables timely batch release and market access.

Impurity & Contamination Control

Solvias’ Impurity & Contamination Control service ensures product safety and regulatory compliance by detecting and quantifying impurities. With nearly 30 years of experience, we specialize in nitrosamines, residual solvents, heavy metals, and genotoxic impurities using advanced techniques like LC-MS/MS, GC-MS, and ICP-MS. Our GMP-compliant services support method development, root cause analysis, and risk assessment aligned with global guidelines.

Stability Studies

Our Stability Studies service supports pharma and biopharma, companies in meeting ICH and global stability requirements. We offer end-to-end support for study design, storage (ICH zones I–V), testing, and reporting, with continuous monitoring across 100+ climate chambers. Our services cover real-time, accelerated, and photostability studies for APIs and biologics, drug products, medical devices, and packaging.

Excipients & Raw Materials Testing and Release

Our Excipients & Raw Materials Testing ensures the quality and compliance of ingredients used in drug manufacturing. We support testing for 1,500+ materials, following global pharmacopoeias (USP, EP, JP) and custom specifications under GMP standards. Services include identification, purity, and elemental analysis with fast turnaround to meet production and regulatory demands.

Analytical Characterization Services

Our Analytical Characterization Services ensure product identity, purity, and stability across all drug development stages for small molecules and biologics. With 25+ years of expertise and techniques like NMR, LC-MS, GC, HPLC, and ICP-MS, we provide tailored method development, validation, and impurity profiling. These GMP-compliant services support confident IND, NDA, and BLA submissions

Contact us for a complimentary consultation

By the Numbers: Solvias’ Global Footprint

With six facilities worldwide, our operations span 25,000 m² of lab capacity, supported by 800+ employees. We serve over 175 customers globally, including 19 of the top 20 pharmaceutical companies. Our locations include Canton (USA), Kaiseraugst (HQ) and Basel (Switzerland), Utrecht (The Netherlands), Hombourg (France), and Research Triangle Park (USA).

What Our Clients Say

“Solvias’ scientists are highly trained, innovative, and business-minded. Their analytical solutions are outstanding.”

“Their project managers are flexible, responsive, and committed to our success.”

“Solvias is not just a vendor—they are an extension of our team.”

Related Resources

Webinars & Videos

Services

Kaiseraugst