Solvias

We use state-of-the-art analytical equipment and techniques to customise solutions to meet stringent requirements. Our laboratories operate to the highest quality standards under international organisation for standardisation (ISO), good manufacturing practice (GMP), good laboratory practice (GLP) and US Food and Drug Administration (FDA) regulations.

Quality control 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.

Our 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.

Our QC teams have experience in the verification of compendial methods, the transfer of validated analytical methods from customer sites, and the validation of methods directly on site.

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). We also offer a full range of physicochemical studies.

The Solvias polymorphism screening strategy has been optimised through decades of experience, tailored to our customers’ needs. Our optimised screening strategies, combined with cutting-edge, high-throughput technology and rapid analysis by X-ray powder diffraction (XRPD) or Raman spectroscopy, provide the maximum information with the minimum amount of the valuable drug substance.

Integrated analytical services for impurities testing

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, we 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. All our equipment is in line with the latest European Medicines Agency (EMA) and FDA methods. We use 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.

Assays to support mRNA-based Covid-19 vaccines

Ribonucleic acid (RNA) based technologies are among many innovative approaches explored to tackle the Covid-19 pandemic. However, messenger RNA (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.

Biopharmaceutical analytical services

Solvias supports its customers with proven expertise at every phase of the development process for large and complex molecules.

Our 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).

Our experts can address complex analytical challenges around the entire spectrum of biologics. These include 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.

About Solvias

Since its establishment as a management buy-out of a dominant pharmaceutical company in 1999, Solvias has developed an unrivalled track record in integrated analytical services and solutions.

Our headquarters and central laboratories are in Kaiseraugst, Switzerland, and our complementary facilities in Basel form a hub with our site for specialised biological analyses across the border in Hombourg, France.

Our team of more than 500 highly qualified employees deliver innovative solutions to 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.