6 services found

Solvias AG Services

Biopharmaceutical Analysis
Protein Characterization Services

Solvias provides comprehensive cGMP services at every stage of drug development. We can fully characterize any protein biopharmaceuticals for the Chemistry and Manufacturing Controls (CMC) section of Investigational New Drug applications (INDs), New Drug Applications (NDAs) and Biologic License Applications (BLAs).
Protein Stability Studies

We understand that early assessment of a protein biopharmaceutical’s stability can be invaluable, even during pre-development. For drug substances and drug products all stability aspects can be monitored including long term and accelerated stability studies, in use studies, short term temperature excursion studies, and forced degradation studies according to ICH guidelines Q5C and Q1B.
Protein Method Development and Validation Services

At Solvias, we perform complete analytical development programs across our multidisciplinary laboratory infrastructure at our Kaiseraugst site. We understand that you need to progress rapidly and cost effectively at the early stage of drug development. Here, our extensive experience saves you time and we can normally apply generic methods to your protein. You can trust us to select promising analytical methods – and carry out development,...
DNA Sequencing, PCR Technology, and Molecular Biology Services

We provide you with access to the highest quality DNA sequencing, PCR technology and customized molecular biology facilities. Our guiding principle is to add value through providing services that are targeted to your specific needs, in the most cost effective manner. The services range from a basic service with pre-cycled sequencing, up to publication quality double stranded sequencing. In addition, cGMP sequencing is available. You can expect rapid...
Protein Quality Control

Solvias has a proven track record in the timely delivery of identity, strength, quality, purity and potency information. This is the cornerstone of quality control and release testing.
Analysis of Biosimilars, Follow-on Biologics

Solvias has a track record over several years in supporting the cGMP analysis of biosimilars (European terminology) or follow-on biologics/follow-on protein products (terminology of the US Food and Drug Administration).

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Solvias AG Services

Biopharmaceutical Analysis

Protein Characterization Services

Protein Stability Studies

Protein Method Development and Validation Services

DNA Sequencing, PCR Technology, and Molecular Biology Services

Protein Quality Control

Analysis of Biosimilars, Follow-on Biologics