Novel trend in the pharmaceutical industry is the design and development of biomolecular therapeutics for curative purposes. Peptides and proteins are naturally occurring large molecules consisting of amino acids that are crucial for proper body functioning. Even though, the industry is focused on developing and manufacturing of biopharmaceutical products, launching them on the market is limited due to the long-lasting and expensive development as a result of the specific characteristics of those macromolecules including their size, hydrophilic nature and instability.
One of the major challenges dealing with proteins is to ensure their stability as well as their characterization by appropriate analytical methods due to the complex multi-level structural organization.
Moreover, there are different types of nutraceuticals on the market (food or food product that can offer both health and medical benefits for the prevention and treatment of disease) that contain peptides or proteins as active ingredients with several positive functionalities.
Quality control is becoming a necessity in today’s dietary supplements marketplace especially for companies that want to be competitive and aspire to deliver high-quality products to their customers. The complexity of the dietary supplements presents significant challenge for in-process control during manufacturing and requires the use of sophisticated analytical methods to verify the identity as well as the quality of the final product.
The use of peptides and proteins as active ingredients in products requires their availability in pure form. An important aspect of quality assurance is also the perseverance of those peptide ingredients during production and storage.
For content determination established analytical methods must be available, properly validated according to the current guidelines.
High performance liquid chromatography (HPLC) is considered as a method of choice for analytical characterization of peptides and proteins. Various HPLC techniques developed for the separation of proteins rely on the differences in the adsorption characteristics, partition, surface charge, ligand specificity and molecular size. The most commonly used HPLC techniques for peptides and proteins are reversed phase, ion-exchange, affinity, and size-exclusion chromatography. The introduction and advancements of the chromatographic techniques for purification and analysis of peptides and proteins played a critical role in the development of peptide and protein-based pharmaceuticals as well as nutraceuticals.
HPLC coupled with a mass detector (LC-MS) is an additional technique that is already widely used in the analysis of peptides and proteins. The advantages of this technique include better selectivity (more reliable separation from other components of the sample) and sensitivity (lower detection limit of the analysed component) as well as shorter run time. Moreover, the use of mass detector enables direct identification of impurities and trace components without the use of reference standards. Due to the aforementioned advantages and recent technical advancements in the field of LC-MS instrumentation, such applications in routine quality control are expected to rise in near future.
OUR EXPERTISE
INSLAB d.o.o. has equipment and expertise to provide analytical services for peptides and small proteins. Our laboratory is specialized for method development, validation and employment of the validated methods for accurate quantification of the active ingredients in various matrices.
Furthermore, our contract laboratory can assist you with the development of dietary supplements with expertise and support services such as: technical advice, development and validation of analytical methods, product comparison, competition analysis etc. We would be pleased to carry out the analysis for you and provide quick, competent and reliable support.
Many more assays are available. If you require a specific assay contact us: info@inslab.si.
Tags: HPLC analysis of proteins and peptides, LC-MS analysis