We provide experienced insight in your drug-specific journey
Small molecule solutions
Characterization, quantification and quality control of pharmaceutical compounds to ensure safety, efficacy and compliance with regulatory standards. Techniques such as liquid chromatography, mass spectrometry and dissolution and spectroscopy are commonly used to assess purity, potency and degradation products. Analytical method development plays a critical role in ensuring consistency across batches, while stability studies help to determine shelf life. Advancements in analytical technologies continue to enhance sensitivity and accuracy, improving drug formulation and manufacturing processes.
Supported by our sister unit AnaBioTec
Biologics
solutions
Characterization and quality control of complex macromolecules such as proteins, monoclonal antibodies, and derivatives. Due to their structural complexity and sensitivity to environmental factors, advance analytical techniques like liquid chromatography coupled to mass spectrometry, capillary electrophoreses and bioassays are used to assess identity & purity, potency, post-translational modifications and process related impurities & contaminants. Innovations in high-resolution analytics and bio-specific assays continue to enhance the precision and reliability of biologics development and manufacturing.
Supported by our sister unit AnaBioTec
Cell & gene
therapy solutions
Characterization and quality assessment of living cells, viral vectors, and genetic materials to ensure safety, potency, and consistency. Due to the complexity of these therapies, specialized analytical techniques such as flow cytometry, RT-qPCR and potency assays are employed to assess identity, purity, potency, and process related impurities and contaminants. Advancements in analytics continue to improve precision, enabling better control over these highly personalized and innovative therapies.
