Focussing on the development, validation and execution of wide-ranging cGMP analytical strategies, from routine tests to the application of state-of-the-art instrumental analysis, such as mass spectrometry
Almac are experts in providing biopharmaceutical analysis such as analytical R&D, characterisation and specialised technologies to support every stage of biopharmaceutical development in line with ICH Q6B guidelines. Our GLP/GCP/cGMP compliant laboratories ensure the highest quality and purity of biopharmaceutical products critical for success.
We offer support for biopharmaceutical testing by providing services from early drug development right through the entire product life-cycle. With over 15 years’ experience servicing clients’ needs, we provide analytical solutions from preclinical activities to bioanalysis of clinical specimens, in addition to quality control testing of small and large molecules, raw materials and finished products.
Services we offer for biopharmaceutical analysis:
- Structural characterisation and confirmation
- Physiochemical properties
- Process-related impurities
- Product-related impurities
- Biosimilar comparability studies
- Potency testing
- QC release testing of biopharmaceutical products
- Analytical technologies