ABOUT SOLVIAS
Solvias brings more than 25 years of experience as a leading provider of chemistry, manufacturing, and control (CMC) analytics to the global life sciences industry. Our expert teams combine deep scientific insight with regulatory expertise across small molecules, biologics, and advanced modalities, including cell and gene therapies. We deliver end-to-end analytical solutions spanning raw material testing, method development and validation, through to drug product release and stability programs. Headquartered near Basel, Switzerland (Kaiseraugst), Solvias operates five global Centers of Excellence — in Kaiseraugst (Switzerland), Research Triangle Park (North Carolina, USA), Hombourg (France), (Massachusetts, USA), Utrecht (Netherlands) — all adhering to the highest ISO, cGMP, GLP, and FDA standards. For more information, visit solvias.com.
INDUSTRY INSIGHTS
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![FDA Seal of approval-GettyImages-1977218350]( "What Recent FDA CRLs Reveal About CMC")
FDA-released CRLs reveal common reasons drug applications miss approval. Many point to recurring CMC issues that can be identified and addressed earlier in development.
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![GettyImages-1337837329 regulatory, paperwork, writing]( "Expert Q&A: What A Submission-Ready E&L Strategy Really Looks Like")
Underestimating E&L risks can delay approvals. A risk‑based, product‑specific approach — supported by strong analytics and toxicology — helps teams identify issues early and move forward with confidence.
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![GettyImages-547131922 research, regulatory, lab]( "What FDA CRLs Reveal About Method Validation")
FDA rejection letters reveal validation failures are structural, not technical. Weak lifecycle oversight, robustness, and documentation continue to delay approvals despite clear guidance.
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![GettyImages-1168902334 FDA]( "What FDA CRLs Reveal About CCIT")
FDA rejection letters show common CCIT gaps — low sensitivity and incomplete validation. Spotting these trends helps teams strengthen integrity testing and avoid approval delays.
CONTACT INFORMATION
Solvias
2400 Perimeter Park Dr.
Morrisville, NC 27560
UNITED STATES
Phone: +1 984-253-7170
PRODUCTS & SOLUTIONS
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![Solvias]( "Solvias Capabilities Update March 2026: Analytical Services")
A biotech leader highlights end‑to‑end analytical capabilities from development to commercialization, with expertise in biologics, gene therapies, quality testing, and regulatory solutions.
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![Oligonucleotides-GettyImages-2234236209]( "Oligonucleotides LC-MS: Support From Development To Release")
A clear look at analytical strategies that strengthen oligonucleotide development, from LC‑MS identity and purity checks to potency assessment, ensuring confidence from early development through release.
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![antibodies-GettyImages-2240716957]( "Monoclonal Antibodies & Antibody-Drug Conjugates")
A clear overview of analytical solutions for mAbs and ADCs, covering structural characterization, potency, genetic QC, stability, and biosafety. Learn how comprehensive testing supports safer, more consistent biologics from early development through commercial release.
CASE STUDIES
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![genetic research, biotechnology, molecular biology, innovation, healthcare solutions-GettyImages-2234236209]( "Strengthening cIEF Method Validation With cIEF-MS")
Preparing for method validation, a biopharma company needed to characterize cIEF charge variants and confirm peak identities for regulatory readiness.
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![biotech-biopharma-GettyImages-2249359729]( "Confirming Structural Consistency With HDX-MS")
To support regulatory confidence, a biopharma company evaluated whether manufacturing changes affected its monoclonal antibody's higher-order structure.
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![biologic-tech-transfer-GettyImages-2157720330]( "Confident Sialic Acid Identification With MS/MS")
Traditional mass spectrometry left uncertainty around potentially immunogenic glycans. Learn how a biologics developer achieved regulatory-ready clarity.
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![antibody molecules-GettyImages-2165626333]( "Building A Smarter Potency Strategy For Bispecific Antibodies")
A biotech company needed a regulatory-ready potency strategy for a bispecific antibody. This organization combined orthogonal analytics with functional assays.
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![peptides-preclinical-develop-GettyImages-2264393871]( "Developing A Robust Crystallization Process For A High-Molecular-Weight Peptide")
Scaling peptide crystallization is complex, with solid forms, polymorphic impurities, and solvent constraints all impacting quality and manufacturability.
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![Getty Images-823447656-vector-viral-lab-AAV-cell-development]( "Characterizing AAV Payload With GMP-Compliant svAUC")
Ensuring AAV quality starts with payload characterization. Learn why conventional methods may miss key capsid population insights.
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![GettyImages-2193144544-scientist-cell-culture-in-lab]( "Revealing Hidden Integration Events With TLA And Nanopore Sequencing")
When standard methods fell short, a biotech company used advanced analysis to confirm targeted construct integration and detect hidden genome changes.
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![clinical-cmo-partnership-GettyImages-1371822410]( "From Variability To Validation – GMP Bioassay Success Through Partnership")
Turn your inconsistent bioassays into GMP-validated, high-reliability platforms — just like we helped a biopharma partner cut failure rates from ~25% to <1%.
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![biologics-bioassay-GettyImages-1138314395]( "Case Study: The Right Ratio – Building An End-To-End DAR Strategy For ADC Success")
When developing antibody-drug conjugates (ADCs), a robust drug-to-antibody ration (DAR) strategy isn’t just nice to have — it's mission-critical.
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![cell-therapy-GettyImages-1494029118]( "Case Study: Full Clonality Assessment Of CHO Cell Line")
In this case study, a comprehensive genetic analysis was performed on a transgenic Chinese hamster ovary (CHO) master cell bank to characterize the bank and provide high-confidence evidence of clonality.
