Solvias USA, Inc. - MA US Laboratory

Overview

Solvias is a world leading CRO/CDMO headquartered in Switzerland with 6 sites across the U.S. & EU. Drawing on a proven 25-year track record of scientific excellence, we provide cGMP-compliant contract analytical services to help you bring safe and effective therapies to patients faster. Partner with us to gain access to a wide range of capabilities for characterization of biologics, ATMPs and small molecule drugs and method development, release testing and stability services. We also offer one of the largest ligand portfolios for catalytic transformations and a suite of related custom API synthesis and catalysis technology services.

Standards & Methodologies

USP, EP, JP, ISO

Qualifications, Certifications, Accreditations & Licenses

ISO9001, ISO17025, GMP, GLP, 21 CFR Part 11, DEA, FDA inspected

Lab Gallery

Industries Served

Biopharmaceuticals
Biotechnology
Cell Lines and Cell Cultures
Gene Therapy
Laboratories or Research Facilities
Laboratories or Research Facilities
Life Sciences
Medical Devices
Packages and Packaging
Pharmaceutical
Pharmaceutical - Pediatric
Pharmaceutical - Active Pharmaceutical Ingredients (API)
Pharmaceutical - Compounding
Pharmaceutical - Over the Counter (OTC)
Pharmaceutical - Small Molecules
Pharmaceutical - Sterile
Pharmaceutical Excipients
Pharmaceuticals - Large Molecules
Veterinary Medicine

Testing Types

Amino Acid Analysis
Analytical Chemistry
Antibody-Based Identification
Antimicrobial Effectiveness Test (AET)
Antimicrobial Efficiacy
Assay Development
Assay Development
Assay Specificity
Atomic absorption (AA) spectroscopy
Bioassay
Biological Characterisation
Biophysical
C-terminal Sequences
Cell and Molecular Biology
Cell Characterization
Cell enzyme bioassays
Cell Line Development
Cell proliferation bioassays
Cell Viability
Chemical Contaminants
Chromatography
Chromatography Purity
Cleaning Process Validation
CMC, complement-mediated cytotoxicity bioassays
Compendial Methods
contaminant identification
Crystal Structure Characterization
Dissolution
DNA PCR
Drug Development
Drug Discovery
Drug Release/Dissolution
Dynamic Light Scattering (DLS)
Electron Microscopy
Electron Microscopy with Energy-dispersive X-ray spectroscopy (SEM-EDX)
Elemental Analysis
Elemental Impurities
ELISA
Endotoxins
ESI-MS
Experimental Design
Extractables
Extractables / Leachables
Feasibility Studies
flame atomic absorption spectroscopy (FLAA)
Flow Cytometry
forced-degradation stability studies
Foreign Material Identification
Formulation Development
freeze-thaw
Gas Chromatography
Gas Chromatography/Flame Ionization Detection (GC/FID)
Gas chromatography/mass spectrometry (GC/MS)
Gas Permeability
GC/MS
GC/MS (Gas Chromatography/Mass Spectrometry)
Gel Clot
Gel Permeation Chromatography
Gene Expression
Gene Expression Profiling
Gene Mutation Assay
Gene Sequencing
Glycopeptides
Host Cell Impurity
HPLC
HPLC Gradient
HPLC-UV
Immunoassays
inductively coupled plasma - optical emission spectroscopy (ICP-OES)
Inductively Coupled Plasma Spectroscopy with Mass Spectrometry (ICP-MS)
Inorganic Species by ICP-OES
Ion Chromatography
Karl Fischer
Leachables
Ligand Binding Assays (LBA)
Liquid Chromatography Tandem Mass Spectrometry (LC/MS/MS)
Liquid Chromatography-Mass Spectrometry (LC-MS/MS)
Loss on Drying (under Vacuum)
Lot Release
MALDI-TOF
MALDI-ToF Mass Spectrometry
Mass Spectrometry
Method Development
Method Transfer
Method Validation
Microbial Enumeration Test (MET)
Microbial ID
Microbial Limit Testing (MLT)
Minimal Inhibitory Concentration
Molecular Structure
Molecular Weight Distribution
Monograph Verification
Multi-Angle Light Scattering (MALLS)
N-terminal Sequences
N-terminal Sequencing Nano flow RP-HPLC MS/MS Nano spray MS
Nitrates
Nitrites
Nitrosamines
Non-Routine Analytical
Non-Volatiles
Nuclear Magnetic Resonance Spectroscopy NMR
Odor
Optical Emission Spectrometry (OES)
Optical Microscopy
Optical Rotation
Osmolality
Osmolarity
Package Integrity
Packaging Analysis
Particle Analysis
Particle Identification
Particle Size Distribution
Particulate Contamination
Peptide Mapping
pH
Pharmaceuticals
Photostability
Physical Chemistry
Polymerase Chain Reaction PCR
Polymorphism
Post Translational Modification Studies (PTM)
Potency Verification
Preclinical
Preservative Challenge
Process Chemistry
Process Optimization
Product Development
Protein and Peptide Analysis
Protein Characterization
Protein Structural Characterization
Proteomics
QPCR
Qualification
Quality Control
Rapid Sterility
Raw Material
Real-Time Stability
Refrative Index
Related Substances
Research and Development (R&D)
RNA Analysis
Robustness
Scanning Electron Microscopy (SEM)
Scanning Probe Microscopy (SPM)
Scanning-Force Microscopy (SFM)
Seal Integrity
SEM / Scanning Electron Microscopy
Semi-Volatiles Analyses
Simulated Use
siRNA Interference Assay
Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)
Solid-State Characterization
Soxhlet Extraction
Specific Rotation
Specificity
Spectroscopy (UV/VIS
Sterility
SVOC
Technology Transfer
Thermogravimetric analysis (TGA)
Total Organic Carbons (TOC)
Trace Elemental Analysis
Unknowns Identification
USP Monograph
UV/Visible Absorption
Visual Inspection
Volatile organic compounds (VOCs)
Wavelength Dispersive X-Ray Fluorescence Spectrometry
Western Blot
X-Ray Diffraction
XRD
XRF

Publications

Antibody-Drug Conjugates: Overcoming Analytical Challenges in Next-Gen Cancer Therapies (White Paper)
Advancing peptide Therapeutics: Challenges and Opportunities in a Booming Market (White Paper)
Understanding and Implementing USP <665> for Single-Use Systems (White Paper)
The Potency Puzzle: Overcoming Challenges in Potency Assays for Cell and Gene Therapy Development (White Paper)
Crystal Clear Vigilance: Detecting Crystallization in ASDs (White Paper)
The high-stakes nature of nitrosamine impurities in APIs (White Paper)
The True Cost of Inadequate E&L Testing (White Paper)
Highly Sensitive Analysis of Glycans in Therapeutic Glycoproteins (White Paper)
Targeted Locus Amplification and NGS combined with qPCR-based breakpoint analysis for the assurance of monoclonality in recombinant cell lines (White Paper)
Solvias to Build Biologics and Cell & Gene TherapyTesting Center in Research Triangle Park (Press Release)
Cergentis is Now Solvias NL (Press Release)
Solvias USA, Inc. Registers with Contract Laboratory - The Laboratory Outsourcing Network! (Press Release)
Solvias to Perform Release Testing on World?s First CRISPR-based Gene-Editing Therapy (Article)
Cergentis is Now Solvias NL (Press Release)

DISCLAIMER: This Laboratory Profile was provided by the company above.