European leader in analytical sciences

       

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Services

First, let us answer a frequently asked question... "Why Quality Assistance?"
Because we are recognized by our customers as a European leader in analytical sciences.

Over the last 34 years we have acquired comprehensive analytical expertise on new and innovative medicinal products.
Our knowledge of EMA, FDA and ICH guidelines and the specific needs related to each particular medicinal product allows us to define our investment strategy and stay at the forefront in the (bio)pharmaceutical sector.

We can therefore provide you with complete analytical support for the development and marketing of your innovative drugs.

Moreover, all our laboratories are located on one site:

  • Bioanalysis (PK/TK/Immuno)
  • Bioassays
  • Biochemistry
  • Chromatography
  • Elemental Impurities
  • Mass Spectrometry
  • Microbiology
  • Molecular Biology
  • Protein Characterisation

This means our Scientists have in-depth knowledge of your product, no time is wasted transferring methods from one site to another, there is an immediate solution when another technique is needed, you have a complete stability programme at the same place, and so on.

We can handle all risks - chemical (cytotoxic, highly potent, hormonal, allergenic), physical (radiolabelled) and biological (BSL2+, clean rooms)- as well as samples which need particular authorization (narcotics, psychotropics, animal by-products not intended for human consumption).

In short, we can summarize our added value as follows:

  • All laboratories on one site
  • Scientific soundness
  • Customised solutions
  • Respect of timelines
  • State-of-the-art equipment and premises
  • FDA inspected


You will find here a description of the services we offer, arranged by product category and by core study.

Products
You can discover the full range of services we provide for the drug you're currently developing :
New Chemical Entities
NCEs Protein Kinase Inhibitors (PKIs) Peptides
nce-new-chemical-entities-quality-assistance protein-kinase-inhibitors-pki-quality-assistance synthetic-peptides-biologics-quality-assistance
Oligonucleotides    
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Biologics
Antibody Drug Conjugates (ADCs) Monoclonal Antibodies (mAbs) Proteins
adc-biologics-quality-assistance monoclonal-antibodies-mabs-biologics-quality-assistance proteins-biologics-quality-assistance
Nanomedicine products
vaccines-quality-assistance
Advanced Therapy Medicinal Products
Cell-Based Medicinal Products Gene Therapy Medicinal Products
cell-based-medicinal-products-atmps-advanced-therapy-medicinal-quality-assistance gene-therapy-medicinal-products-atmps-advanced-quality-assistance
Vaccines
vaccines-quality-assistance
Core studies

You can also discover our capabilities by type of studies.

These are the ones you need to do to complete in the Common Technical Document :

Analytical development Bioanalysis Stability studies
core-studies-analytical-development-quality-assistance core-studies-bioanalysis-quality-assistance core-studies-stability-quality-assistance
Batch testing Elemental Impurities  
core-studies-batch-testing-quality-assistance elemental-impurities-quality-assistance
Study & Technical sheets

We reserve the access to detailed technical information for our favorite guests.  Ask for a login


Your personnal access gives you privileged access to documents written by our Scientific and Regulatory Committee on specific analytical topics.
This allows us to share with you both technical and regulatory information on :

 

The Luminex MAGPIX system is a multiplexing platform for the simultaneous detection of biomolecules in biological samples using bead-based assay.
Luminex can be used for multiple applications in several biological fluids (serum, plasma, cell culture supernatants, …)

Although drug products issued from biotechnology have now been on the market for many years, accurate protein quantification remains a challenge. There are many colorimetric methods for protein quantification (Lowry, Bradford, BCA) but they all lack precision, and suffer from interferences and matrix effects, moerover, the accuracy is highly dependent of the protein used for calibration (...)

Cytokine profiling is a powerful tool to link the host immune system with disease pathogenesis and/or treatment efficacy.
 
The analysis of cytokine expression is frequently required for the characterisation of the status of the immune system, to demonstrate the functionality of the cells of interest and as an analysis of surrogate markers for in vitro potency testing.(...)
On January 1st 2018, all new and existing drug products will have to comply with the ICH Q3D guideline for elemental impurities (EIs). Although this guideline sets specifications for drug products only, the risk assessment approach also involves the determination of metallic impurities in APIs and excipients.
 
In this context, Quality Assistance offers consultancy for risk assessment and state-ofthe-art expertise to perform the requested analyses (including two generic ICP/MS methods for the determination of all EIs listed in Q3D).(...)

Physico-chemical analysis of glycosylated proteins.

Efficient bioanalytical support is critical for the success of non-clinical and clinical development leading to the marketing of a medicinal product. As an expert partner, Quality Assistance provides solutions at each step, from the development and validation of bioanalytical methods to the analysis of late clinical study samples, in an ever more demanding environment. We use cutting-edge technical resources to successively validate highly sensitive robust methods and analyse large numbers of samples as studies progress.

Over the years, Quality Assistance has acquired valuable expertise in developing, validating and performing a wide spectrum of different antibody-based assays for different stages of (bio)pharmaceutical product development.

Biologics are known to have a greater potential for inducing immune response than conventional small molecule drugs. Consequences of this immune response include altered pharmacokinetics, loss of efficacy, cross-reactivity and mild to severe clinical side effects.

As a significant safety and efficacy problem, immunogenicity is a major concern for regulatory agencies (...)

For drug products requiring reconstitution, dilution, preparation for infusion and to be administered IV to subjects in a clinical trial, data regarding the post-dilution stability over time and the compatibility with the container have to be provided.(...)

Protein PEGylation is a great tool to improve the delivery of therapeutic proteins,but it adds a level of complexity to the product. As well as the characterisation of individual components (PEG and protein), the conjugate also has to be thoroughly characterised.

In addition to all the analytical tests proposed for proteins, Quality Assistance has developed specific methods for the analysis of PEGylated proteins (...)

Peptide mapping is an identity test for proteins. When combined to mass spectrometry, it can also be used for stability testing. It involves the chemical or enzymatic treatment of a protein resulting in the formation of peptide fragments. The fragments are then separated and identified using suitable analytical techniques.(...)

According to ICH guidelines*, potency is the measurement of biological activity using a suitable quantitative biological assay (also called potency assay or bioassay) based on the attribute of the product which is linked to the relevant biological properties.

During the development of a pharmaceutical product, the potency assay is now well recognized as essential to quantify the biological effect of the product (...)

* ICH Guidelines Q6B : Specifications: Test procedures and acceptance criteria for biotechnology/biological products, 1999

Protein aggregation is a major concern for biotherapeutics as the aggregates may compromise the safety (by enhancement of immune responses thus causing adverse clinical effects) and efficacy of a drug product.

Although there is still no specific guidance on biopharmaceutical protein aggregates, regulatory agencies have clearly highlighted the need for the indepth characterisation and monitoring of aggregation.

Over the past 40 years, Capillary Electrophoresis (CE) has emerged as an indispensable tool in the (bio)pharmaceutical industry.

CE has become a method of choice in Research and Development for molecular characterisation and in Quality Control for the release of therapeutic molecules (...)

Flow cytometry is a technology that simultaneously measures and analyzes multiple physical characteristics of single particles, usually cells, as they flow in a fluid stream through a beam of light (...)

Scientific data

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Scientific posters
Publications and Application Notes
Webinars
Conferences

 

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