Study & Technical sheets

Endotoxins and pyrogens testing

Bacterial endotoxins and pyrogens (both endotoxins and non-endotoxin pyrogens (NEPs) from bacteria, viruses, yeasts, and molds) are critical quality attributes (CQ

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MALDI-TOF autoflex maX

The autoflex maX is a matrix-assisted laser desorption ionisation (MALDI) with tandem Time-of-Flight (TOF/TOF) mass spectrometer from

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Silicone-based impurities determination in biopharmaceuticals

Organosilicon-based compounds such as PDMS (low-molecular weight polydimethylsiloxane, i.e., Dimeticone, Simeticone, Antifoam A®

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Separation and biophysical characterisation of macromolecules

Multi-Angle Light Scattering (MALS) detection allows for the determination of molecular weight distribution of biomolecules after size-exclusion chromatography (S

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KingFisher Flex

The KingFisher Flex is a device that automatically processes nucleic acids, proteins or cell samples.

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Digital Droplet PCR (ddPCR)

PCR (Polymerase Chain Reaction) is a method used to quantify nucleic acids.

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2D UPLC/MS

The 2D UPLC/MS system allows the online combination of two chromatographic columns with hyphenation to mass spectrometry.

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CytoFlex LX

Our latest FACS model features 6 active lasers and can perform up to 21 color marker analysis, allowing us to reduce cross talk and spectral overlap

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Statistical services

Beyond analytical services, Quality Assistance provides advanced statistical consulting and analytical data management services on one site.
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Octet

Quality Assistance is equipped with an Octet RED96e system, available in a fully GxP-compliant environment.
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Surface Plasmon Resonance

Biacore technology offers label-free assays that provide precise and reliable concentration and kinetic measurement. This can be applied through all stages of product development, from discovery to quality control.
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Potency assays

Quality Assistance is specialised in the development and/or optimisation, validation and transfer of a very wide range of potency assays.
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PEGylated Proteins

In addition to all the analytical tests proposed for proteins, Quality Assistance has developed specific methods for the analysis of PEGylated proteins.
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Absolute quantification of proteins by ICP/MS

Fast and accurate assay of single proteins by isotope dilution ICP/MS without the need of reference substance
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Flow Cytometry

Flow cytometry is a technology that simultaneously measures and analyses multiple physical characteristics of single particles as they flow in a fluid stream through a beam of light.
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High Performance NCE Bioanalysis

High Sensitivity and High Throughput Bioanalysis of New Chemical Entities (NCEs)
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Elemental Impurities

We offer consultancy for risk assessment and state-of-the-art expertise to perform the required analyses.
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Bioanalytical services

Quality Assistance offers a wide range of solutions for the analysis of biological samples.
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Capillary electrophoresis

Capillary Electrophoresis has become a method of choice in R&D for molecular characterisation and in Quality Control for the release of therapeutic molecules.
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Analytical Development

Sound expertise for the development, transfer and validation of analytical methods
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Protein aggregation

Protein aggregation is a major concern for biotherapeutics as the aggregates may compromise the safety and efficacy of a drug product.
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Immunogenicity

Centralised solutions for the assessment of the potential immunogenicity of your product
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Immunoassays

Expertise in developing, validating and performing a wide spectrum of different antibody-based assays for different stages of (bio)pharmaceutical product development.
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Stability studies

We are able to support you on the long term for stability studies related to clinical trials application, product licence application and post-approval monitoring.
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Glycosylation

Quality Assistance analytical platform for the Physicochemical characterisation of Glycosylated Proteins
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