VelaLabs is expanding its physico-chemical portfolio via the implementation of a range of diverse structure determination methods.
New Analytical Capabilities at VelaLabs
Recently, VelaLabs entered into the world of liquid chromatography mass spectrometry (LC-MS), gas chromatography mass spectrometry (GC-MS), size exclusion chromatography multi-angle laser light scattering (SEC-MALLS) and capillary electrophoresis (CE). Subsequent to the acquisition of our new equipment and integration of this innovative technology, we are now offering modern, up-to-date analytical methods for determining structural characteristics of peptides, proteins and small molecules.
Mass Spectrometry of Proteins: An Innovative Era in Characterizing Biological Therapeutics
Mass spectrometry (MS) is a rapidly-emerging technique to characterize protein drug therapeutics. Such proven analytical methods are now routinely used to characterize biosimilars, biopharmaceuticals & biological products during pre-clinical and clinical development as well as analysis of products during process development. The new portfolio at VelaLabs that encompasses protein mass spectrometry consists of three consecutive stages of implementation – each dedicated to support our clients in all phases of product development and before batch release.
Stage 1: Basic Mass Spectrometry Analysis of Your Protein
Here we are focused on establishing and offering fundamental mass spectrometry-based analyses that include:
Stage 2: Characterize and Quantitate Your Protein
For projects that require a deeper level of analysis and/or for our clients that wish to continue further from Stage 1, we can offer additional analyses such as:
Stage 3: Tailored Approaches Dedicated to Your Requirements
For even more advanced projects, we are available to discuss and design specific mass-spectrometry based proteomic approaches that will involve:
These three stages will assist in several important phases of the industrial pipelines of our Clients:
Discovery Phase: Non-GxP proteomic approaches will aid in: (i) clone selection; (ii) monitoring/determining in vitro proteome-wide effects; (iii) absolute quantitation of biomarkers; (iv) characterization of mutant versus wild-type protein forms via intact mass analysis and de novo sequencing; and (v) cross-validation comparison with a traditional portfolio (bioassays etc.)
(Pre-) clinical Studies: Here, LC-MS will provide an analytical portfolio that enables protein-based drugs measurements in complex matrices (e.g., human serum/plasma samples). As a proof-of-principle, a simulated pharmacokinetic (PK) study on pegylated and non-pegylated granulocyte colony stimulating factor (pegG-CSF and G-CSF) and on a second biopharmaceutical, rituximab, is currently evaluated.
Market Authorisation: Protein mass spectrometry will be used to perform: (i) stability studies, e.g., determining the degree of protein oxidation and de-amidation of a biopharmaceutical product; and (ii) comparability studies between batches via peptide mapping and glycoform analysis.
Batch Release: Via peptide mapping, LC-MS will be used to: (i) assess protein product batch-to-batch consistency; (ii) monitor/confirm recombinant amino acid sequences; and (iii) determine the degree of impurities, e.g., via host cell protein analysis. Similarly, intact protein analysis will confirm: (i) complete protein expression; and (ii) the major glycoforms and glycosylation pattern of the Protein.