A Mass Spectrometry (MS) based approach in response to recent regulatory guidance
Malvern, PA, USA and Jersey, GB, February 27, 2018 / B3C newswire / -- BioPharmaSpec, a leading contract research organization (CRO) providing a full range of characterization services for the biotechnology industry, today announced the launch of “The BioPharmaSpec Approach” for MS-based detection of Host Cell Proteins (HCPs). The new in-house service allows Clients access to a pre-existing approach that detects a wider population of HCPs than possible with traditional ELISA technologies.
In contrast to HCP-ELISA, which relies on the presence of polyclonal antibodies for positive HCP detection, The BioPharmaSpec Approach has the distinct advantage of detecting HCPs in a de novo manner, without specialized polyclonal antibody reagents or product / process-specific method development. BioPharmaSpec apply their renowned MS expertise within a clearly-defined, staged approach, which includes:
- Qualitative analysis to identify the HCPs present
- Quantitation against a response from a known spiked protein
- Quantitation of the HCPs against heavy labeled marker peptides
The application of this in-house service was discussed briefly ahead of the formal launch by BioPharmaSpec’s Technical Director for Structural Analysis, Dr. Richard Easton, during a live webinar entitled: “Characterizing Protein Impurities”. The webinar featured case studies of characterizing process related impurities, with an emphasis on Host Cell Proteins. Scientists can watch this webinar on-demand, by clicking here: http://biopharmaspec.com/knowledge-center/demand-webinar-characterizing-protein-impurities/
Dr Andrew Reason, CEO at BioPharmaSpec commented: “Through our significant experience, high-end MS technologies and intuitive, specialized software, our clients have been progressively adopting MS as technique for analyzing HCPs in their products. In turn, this trend has swayed regulatory groups worldwide, who now often recommend the use of MS as an orthogonal approach to HCP-ELISA.”
Dr. Reason continued, “At BioPharmaSpec, we remain committed to positioning ourselves at the forefront of our industry, constantly looking for ways to innovate and bring the best technical service to our Clients. We look forward to serving our industry with The BioPharmaSpec Approach to HCP detection, and improving HCP assessments with the more decisive analytical technique of MS.”
BioPharmaSpec is a CRO specializing in the structural, physicochemical and biophysical characterization of biopharmaceuticals including monoclonal antibodies and their related products (e.g. biosimilars and biobetters, Antibody Drug Conjugates (ADCs), bispecifics and fusion proteins). We assist our clients in a range of analytical areas such as De Novo Protein Sequencing, Peptide Mapping, Disulfide Bridge Assignment, Carbohydrate Analysis and higher order structure assessment. Our analytical data can be used to choose the best cell clone, provide comparability studies and allow solid development decisions to be made based on quality analytical data and experience.
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