QC Analytical Techniques for Peptides & Protein
Are you interested in the development and validation of QC analytical techniques for the study of peptides and proteins?
The development and validation of QC analytical techniques for the study of peptides and complex peptide mixtures is not trivial. In many cases, methods are either non-existent and require full development or are commonly not fit for purpose having been developed for research purposes and need re-evaluation and development before verification and validation. Many laboratories have traditionally worked with small molecules and biologics but peptides, whether they are small molecule peptides ~5-20 aa, large peptides >100 aa or complex peptide mixtures often offer unique challenges that make analytical method development difficult.
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Common tools and techniques (e.g. chromatography, MS, ELISA, SDS-Page) are used but it is more important for the scientists developing methods and analysing samples to understand the attributes of the peptides they are working with and the requirements and parameters for each assay that will affect successful development and application.
Tepnel Pharma Services is an independent CRO with >30 years experience of pharmaceutical testing cGMP analytical services – regulatory compliant analytics in support of small molecules and biologic APIs, IMPs and finished products. Biomarker and CDx development – uniquely placed to support early pre-clinical research and biomarker discovery through to the development, manufacture and regulatory approval of a CDx test.
Peptide speciality
- >50 assays developed and validated
- >10 years experience in peptide analytical method development
- Complementary strategies develop and validate ELISAs including immunogenicity testing, SDS-PAGE, and Western blotting techniques for proteins
- Large biotech to small biotech clients
- Experience with 1 product start-ups that now have marketable products
If you would like to find out more about QC analytical techniques then please fill in your details below.
The following Case Studies are presented as examples of Tepnel’s experience.
Purity method development for peptide drug substances
Development of peptide aggregation method for combined peptide drug product
Development of peptide immunogenicity for detection of anti-drug antibodies in rat serum
Optimisation of an antibody in a colorimetric Western Blot and improvement of the blot transfer process
Tepnel Pharma Services strives to deliver Value, Efficiencies and Opportunities.
Tepnel has a wealth of knowledge and history of performing method development. Our strategy is to employ the principles of QbD to ensure that the most applicable separation and detection solution is created and tailored to the need of our clients.
For >10 years our experience has been extensive in the development and application of separation techniques for peptides. Typically we have likened peptides to small molecules to influence the approach we have taken. This has been successful for over 40+ separations utilising UHPLC with UV and MS detection. To complement this strategy we have the capability to develop and validate ELISAs including immunogenicity testing, SDS-PAGE, and Western blotting techniques for proteins. Tepnel enables wide-ranging expertise in one location to facilitate client requirements.
We are involved in decision milestones on projects and are seen as the technical expert to our sponsors, whether they are large pharma or small biotech. Our scientific team want ownership of your project, we do this by placing an emphasis on quality, communication and scientific understanding. Tepnel aims to perform as a critical member of your team.