Sponsored by Solvias
An internationally recognized provider of integrated solutions in analytical research as well as chemical development and manufacturing of chiral and complex molecules, Solvias offers a complete range of services and solutions.
Integrated expertise in small molecules and biopharmaceuticals
Drawing on a 20-year track record of scientific excellence, our experts develop, analyze and test a wide range of chemical and biological substances. The company offers integrated services for all stages of drug development and production along the entire value chain: elemental and trace analysis, solid-state development, microbiology and biological analysis, ligands and catalyst technology along with custom synthesis and manufacturing.
Beyond our expertise in small molecules, Solvias has built a solid reputation with biopharmaceutical companies for the characterization and analysis of monoclonal antibodies, therapeutic proteins and biosimilars. All of our laboratories operate to the highest quality standards in accordance with ISO, GMP, GLP and FDA regulations.
Custom synthesis and catalytic transformation services
Solvias has a proven track record in the development and production of a wide spectrum of active pharmaceutical ingredients (APIs) under GMP up to Phase II. Our process R&D facility allows for rapid transfer of processes to kg-scale. All activities are fully supported by Solvias’ in-house analytical and microbiology services as well as by our quality assurance.
As part of our custom synthesis and route-scouting service, Solvias is supported by a highly experienced catalysis group. Our experts specialize in the development of catalytic transformation using high-throughput experimentation in combination with our in-house database and extensive catalyst library of more than 500 ligands (Solvias, third party and generic). Solvias’ modular and well-established ligand families offer a wide application range in asymmetric hydrogenations, C-X couplings and asymmetric C-C bond formations.
Finally, our solid state department provides support in salt and polymorph screening as well as crystallization development. Working in close collaboration, these teams bring their specialized know-how and advanced equipment to investigate crystallization steps in detail and at scale.
Industry-leading expertise in solid-state development
Proven expertise in solid-state development is backed by deep understanding of the science. Solvias offers a comprehensive approach to solid-state development, from systematic salt, co-crystal and polymorph screening to controlled scale-up of the crystallization process and quality control of both the drug substance (DS) and drug product (DP), along with a full range of physico-chemical studies.
The Solvias polymorphism screening strategy has been optimized through decades of experience and is tailored to our customers’ needs. The combination of our optimized 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 techniques for impurities testing in drug products
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 over 100 methods for the identification, development and validation of methods for quantification of impurities. In particular, Solvias is able to 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 EMA and FDA methods using
Q-Exactive Orbitrap, ThermoFisher Scientific LC-MS/MS and GC-MS/MS systems. Data integrity is guaranteed through fully compliant Chromeleon software.
Solvias is ready to discuss the ways in which its experts can potentially help with your next project. Whether you are a new or existing customer, the group will be delighted to discuss your needs and to fully support you along the entire value chain of drug development and production.