Take no risk with your analytics when developing new therapeutic monoclonal antibodies.
Our analytical teams take advantage of their extensive experience in the analysis of mAbs. Throughout non-clinical and clinical development, our experts provide you with the customised solutions in terms of analytical protocols and innovative technologies to help you move your product from discovery to the market place.
Your analytical partner providing:
customised solutions in terms of analytical protocols and innovative technologies throughout non-clinical and clinical development.
a full range of equipment in Chromatography, Mass Spectrometry, Biochemistry, Cell Biology, Pharmaceutical Technologies and Microbiology, to meet all the challenges of developing and validating methods.
regulatory, scientific and technical excellence with a problem-solving approach
compliance with all applicable EMA, FDA and ICH regulations
GMP, GLP, GCLP/GCP environment
Your one-stop shop for analytical services
Outsource your analytical needs on one site for more efficiency including:
Analytical development
Validation of analytical methods as per ICH guidelines
Characterisation of mAbs
Bioassays
Bioanalysis
Stability studies
Batch testing
MCB & WCB
Characterisation
FACS / ICC (Immunocytochemistry)
Microbiology
Bioburden / Sterility (filtration, direct inoculation) / Mycoplasma (QPCR)
Plasmid copy number
Q-PCR
GENERAL QUALITY
Appearance
pH / Osmolarity (if liquid)
Water content / residual moisture (if lyophilised)
Take no risk with your analytics when developing new therapeutic monoclonal antibodies.
Our analytical teams take advantage of their extensive experience in the analysis of mAbs. Throughout non-clinical and clinical development, our experts provide you with the customised solutions in terms of analytical protocols and innovative technologies to help you move your product from discovery to the market place.
Multiple Heartcut 2D-LC/MS: a powerful tool for biopharma analysis in a regulated environment
Applications of Multiple-heartcut 2D-LC/MS at Quality Assistance:
Characterisation of monoclonal antibodies
Characterisation of ADCs :
Hydrophobic Interaction Chromatography (HIC) is a method of choice for the characterisation of ADCs. Due to high salt content in mobile phase, it is impossible to hyphenate the chromatography to MS for peak identification. Fraction collection and desalting is time-consuming and is not easily amenable to low concentration species (due to dilution effects)
Quantification of free drugs in ADCs:
Quantification of free drug in ADCs is critical for batch release and during stability studies. Cytotoxic payloads are extremely toxic and low limit of quantifications should be achieved. MS is often required to reach low LOQ, and the protein has to be removed (offline or online) before the analysis. 2D-LC/MS is a way to meet all those criteria
Structural characterisation and epitope mapping by HDX-MS
Hydrogen-Deuterium Exchange Mass Spectrometry (HDX-MS) is an innovative tool for the characterisation of biotherapeutics. Besides the study of higher-order structures, HDX-MS can also be used for epitope mapping studies in order to determine to which region of the target a monoclonal antibody binds. HDX-MS is a good alternative to techniques such as X-ray diffraction or NMR.
Absolute quantification of proteins (i.e. quantification without the need for a reference standard) is a key analysis for the qualification of reference standards or to determine the extinction coefficient of a protein. It is usually performed using amino acid analysis, but this technique shows limited accuracy and repeatability.
Quality Assistancehas developed an innovative method based on the quantification of sulphur by isotope dilution ICP/MS. Unprecedented precision and accuracy can be obtained, which provides a reliable quantification of proteins and determination of extinction coefficients.
Hydrogen-Deuterium Exchange Mass Spectrometry (HDX-MS) is a powerful technique for the advanced structural characterisation of proteins and the study of protein-protein interactions.This technique has been used for several decades, mostly in academic labs. Thanks to advances in automation, liquid chromatography and mass spectrometry technologies, this technique can now be used to get reproducible and reliable results in characterisation studies of biotherapeutics. It is complementary to other structural biology techniques such as NMR and X-ray cristallography. Its main advantage is to work in nearly physiological conditions and to require relatively limited amounts of sample.
Access this 45 minutes webinar to learn how HDX-MS can be applied throughout the development of your product to get structural information that can hardly be obtained with other techniques. After a detailed description of the technique and its applications, case studies will be presented in the context of comparability and epitope mapping studies.
Access this 45 minute webinar to learn how state-of-the-art LC/MS technologies can be implemented for the efficient study of therapeutic protein glycosylation using analyses optimised for each level of information you need.