Silicones are used in pharmaceutical applications as part of formulations, as well as during manufacturing and in packaging.
Solvias is a world leader in contract research and development (R&D), providing the pharmaceutical, biotech and medical device industries with integrated analytical services and solutions for safer products.
The company’s comprehensive analytical testing portfolio integrates a broad range of capabilities spanning all stages of drug discovery, development and manufacturing.
Integrated analytical services and solutions for pharmaceuticals
For more than 20 years, Solvias has brought a unique combination of capabilities to develop, analyse and test a wide range of biological and chemical substances. Integrated analytical services include method development and release testing of traditional and highly innovative products, elemental and trace analysis, solid-state development, microbiology and biological analysis, ligands and catalyst technology, custom synthesis and manufacturing.
Beyond its expertise in small molecules, the group has built a solid reputation with biopharmaceutical companies for the characterisation and analysis of monoclonal antibodies, therapeutic proteins and biosimilars.
We use state-of-the-art analytical equipment and techniques to customise solutions to meet stringent requirements. Its laboratories operate to the highest quality standards under international organisation for standardisation (ISO), good manufacturing practice (GMP), good laboratory practice (GLP) and the Food and Drug Administration (FDA) regulations.
Fast, cost-effective QC release testing
Solvias offers a proven track record in routine quality control (QC) analysis for raw materials, excipients, active pharmaceutical ingredients (APIs) and drug products of various galenic forms.
QC testing capabilities range from solids, semi-solids and liquids for oral, inhaled and injectable use to packaging materials including rubber closures, glass and plastic containers.
Solvias offers the flexibility of working according to compendial methods, United States Pharmacopoeia (USP), European Pharmacopoeia (Ph Eur) and Japanese Pharmacopoeia (JP), proprietary methods or customers’ methods.
Its QC teams have experience in the verification of compendial methods, the transfer of validated analytical methods from customer sites, and validation of methods directly on site.
Industry-leading expertise in solid-state development
A deep understanding of science supports proven expertise in solid-state development. Solvias offers a comprehensive approach to solid-state development, from systematic salt, co-crystal and polymorph screening to controlled scale-up of the crystallisation process and quality control of both the drug substance (DS) and drug product (DP), along with a full range of physicochemical studies.
The Solvias polymorphism screening strategy has been optimised through decades of experience, tailored to our customers’ needs. The combination of our optimised screening strategies with cutting-edge, high-throughput technology and rapid analysis by X-ray powder diffraction (XRPD) or Raman spectroscopy provides the maximum information with the minimum amount of the valuable drug substance.
Advanced integrated analytical services and techniques for impurities testing in pharmaceuticals
Identifying and quantifying impurities in drug products requires a wide range of analytical techniques for structure elucidation and quantification of small molecules, from unknown compounds in release analytics to the development of methods for routine impurities.
Solvias has developed a portfolio of more than 100 methods for the identification, development and validation of methods for quantification of impurities. In particular, Solvias can correctly identify and quantify all five nitrosamines found in recent recalls of angiotensin II receptor antagonists (sartans).
Dedicated experts in extractables and leachables and genotoxic impurities (GTIs) deploy organic trace analysis by liquid chromatography-mass spectrometry (LC-MS), as well as gas chromatography-mass spectrometry (GC-MS) equipment in line with the latest European Medicines Agency (EMA) and FDA methods using Q-Exactive Orbitrap, ThermoFisher Scientific liquid chromatography-mass spectrometry (LC-MS)/MS and gas chromatography-mass spectrometry (GC-MS)/MS systems while guaranteeing data integrity through fully compliant Chromeleon software.
Covid-19: Innovative assays to support mRNA-based vaccines
RNA-based technologies are among the innovative approaches explored to tackle the Covid-19 pandemic. However, mRNA-based vaccines present particular analytical challenges.
Solvias can assist in the method development and testing related to these innovative assays. The current portfolio integrates analytical development for the full spectrum of advanced therapeutic solutions such as vaccines, cell and gene therapeutics, as well as nucleic acid-based products.
Solvias supports its customers with proven expertise at every phase of the development process for large and complex molecules.
Its complete portfolio of capabilities in biopharmaceutical analysis and functional assays includes characterisation studies, method development and validation, stability studies, quality control, and batch-release analysis under FDA current Good Manufacturing Practice (cGMP).
Solvias experts can address complex analytical challenges around the entire spectrum of biologics: monoclonal antibodies, antibody-drug conjugates (ADCs), glycoproteins, PEGylated proteins and peptides, biosimilars and vaccines as well as advanced therapeutic modalities such as gene- and cell-based therapeutic drugs.
Solvias has developed an unrivalled track record in integrated analytical services and solutions since its establishment as a management buy-out of a dominant pharmaceutical company in 1999.
The company’s headquarters and central laboratories are in Kaiseraugst, Switzerland, and complementary facilities in Basel forming a hub with its site for specialised biological analyses across the border in Hombourg, France.
Our team of more than 500 highly qualified employees currently deliver innovative solutions that enable customers to bring safer and better products to the market faster.
Solvias is ready to discuss how its experts can potentially help with your next project. Whether a new or existing customer, the group will be delighted to discuss your needs and explore the methods best suited to your development project or novel therapeutic approach.
Extractable and leachables testing is a profoundly elaborate and challenging subject, not only from a scientific position but also concerning regulatory requirements.
Solvias is pleased to announce that it is taking an interest in the increasing focus on genotoxic impurities.
Excluding animals from the development of innovative medicines is an expanding aim for society, as well as the pharmaceutical industry.
Since the discovery of a single nitrosamine in Valsartan in June 2018, the presence of nitrosamines in drug products has been recognised as a crucial safety concern.
World leader in contract research, development and manufacturing, Solvias, has announced an agreement completion with strategic health care investors, Water Street Healthcare Partners and JLL Partners, to wholly acquire and invest in the growing company.
The Solvias pandemic plan, developed to reduce the risk of Covid-19 infection at the company's sites, guarantees the continuation of analytical testing along with synthesis/catalysis and ligand development services.
ZI rue du Canal d’Alsace
2125 Center Ave
Fort Lee NJ 07024
United States of America