Quality Assistance

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    Quality Assistance

“Gyrolab has transformed the way we run immunoassays by dramatically reducing sample consumption, hands-on time, and overall method development timelines. The platform consistently delivers the sensitivity and robustness we need to support complex drug development programs.”

Quality Assistance has integrated Gyrolab technology into its bioanalytical and CMC operations since acquiring its first Gyrolab xPlore™ instrument in 2022. Since then, the platform has become an integral part of their GxP-compliant analytical services, supporting a broad range of programs spanning early development through clinical and commercial stages. Their Gyrolab capabilities extend across pharmacokinetic and toxicokinetic studies, immunogenicity assessment, biomarker analysis, and CMC applications such as product characterization, batch release, and stability testing. In addition to reducing sample consumption and hands-on time, the bioanalytical team leverages the speed, sensitivity, and robustness of Gyrolab to meet growing industry demands for automation and accelerated timelines. The platform now plays a key role in enabling Quality Assistance to deliver high-quality, reliable, and efficient analytical solutions for complex modalities, including ADCs, mAbs, viral vectors, vaccines, nanomedicines, and gene and cell therapies.

Quality Assistance

Company Description

Quality Assistance is a leading European Contract Research Organisation providing the pharmaceutical industry with all the analytical services required by EMA and FDA regulations for the development and marketing of innovative human medicinal products.

The company holds a unique position in the market with all laboratories located on a single site in Belgium, supported by 280 highly qualified professionals and more than 40 years of expertise at the forefront of analytical sciences.

Quality Assistance supports clients from candidate selection through non-clinical and clinical development to marketing authorization. Leveraging state-of-the-art, product-dedicated analytical capabilities, the company designs customized solutions, defines analytical protocols, and develops and validates new analytical methods. Services include characterisation, stability, pharmacokinetic, biomarker, and immunogenicity studies as well as batch release testing to evaluate product Quality, Safety, and Efficacy.

Bioanalytical Services

Quality Assistance provides a wide range of G(C)LP-compliant bioanalytical services, including:

  • Pharmacokinetics and toxicokinetics studies
  • Immunogenicity assessment
  • Biomarker studies

In addition, the Gyrolab platform is also used for CMC-related analyses such as product characterisation, batch release testing, and stability studies under GMP.

The company offers customized testing based on analytical methods either transferred from clients or developed and validated in-house. Services span biotherapeutics (e.g., ADCs, mAbs), small molecules (NCEs), nanomedicines, vaccines, gene therapies, and cell-based therapies.

Gyrolab Applications

The Gyrolab xPlore is used across multiple applications, including:

  • Determination of viral vector capsid concentration
  • Quantification of impurities (residual host cell proteins, endonuclease, Protein A)
  • PK/TK analysis
  • Affinity and potency assessment based on antibody-target interactions
  • Immunogenicity / ADA detection
  • Quantification of cytokines, chemokines, and biomarkers

Key Advantages of Gyrolab Technology

Gyrolab offers key benefits such as low sample volume consumption, reduced matrix effects, and rapid time-to-results. Its high level of automation significantly reduces hands-on time.

Assay development is typically faster than traditional ELISA while providing improved accuracy, precision, and sensitivity.

When Gyrolab Is a Platform of Choice

Gyrolab is preferred when:

  • Speed and rapid turnaround are critical
  • Minimal sample consumption is required
  • High automation is needed to reduce operator time
  • Assays must be developed from scratch quickly and efficiently

To find out more, visit Quality Assistance website.