Laboratory Testing Blog

In general, the main challenge in protein molecule analysis is that there is no single and universal method or approach for separation and characterization of proteins.  As a first choice, peptide mapping methods are a preferred technique for the comprehensive characterization of biopharmaceutical products.  Its applications include:

First introduced over 100 years ago, USP<231> is a colorimetric procedure based on the precipitation of insoluble metal sulfides.  This test for heavy metals is qualitative rather than quantitative.  It is not an element specific method, nor is it equally sensitive to each metal.  The limits specified by the test are based on the ability to observe the precipitate, rather than on the analysis of toxicological data.  The procedure does not necessarily detect all potential forms and/or valences of elements of concern when they are present as the oxo ions or in the organometallic form.  Chromium and nickel are potential contaminants from modern stainless steel processing equipment and are not detected by the USP<231> test method.  Other studies indicate inconsistent recoveries of monitor and standard solutions using USP<231> method II.2, 3

The efficient characterization of antibody drugs is important to both regulatory agencies and pharmaceutical companies to ensure the safety and efficacy of biopharmaceutical products.  Proteins with different sizes may show similar hydrophobicity and are therefore difficult to separate by traditional reversed-phase chromatography (RP).  

Plants respond to several environmental stresses such as pathogen attack, mechanical or herbivorous insect-driven wounding and the presence of pollutants by the synthesis of secondary metabolites that mediate interplant communication for defense responses.  Among these signalling molecules are phytohormones: jasmonic acid (JA), salicylic acid (SA) and abscisic acid (ABA).  They are considered to be the major regulators of plant defense responses.  The role of salicylic acid in influencing plant resistance to pathogens (aphids, bacteria, fungi) is well documented, whereas jasmonic acid is commonly believed to play an important role in plant responses to insect herbivores and abiotic stress.  The soluble jasmonic acid acts as a direct defense to herbivores or others injuries, whereas the volatile form, methyl jasmonate, represents a plant signal molecule, which serves as an indirect defense mechanism.

The analysis of low abundant signaling molecules such as phytohormones such as jasmonic acid (JA), salicylic acid (SA) and abscisic acid (ABA) and intermediates of metabolic pathways such as free fatty acids (FFA) and oxygenated forms of fatty acids in plants is an important tool to understand how plants grow, develop and respond to stress conditions.  Therefore, it is essential to develop quantitative analytical testing methods for the rapid, simultaneous and reliable analysis of a broad range of plant molecules.

Glycoprotein characterization and glycosylation profiling are important tasks in the development and production of biopharmaceutical proteins.  The oligosaccharides contained in glycoproteins are often responsible for diverse biological functions, such as cellular cytotoxicity.

Protein and peptide drugs cover a broad range of clinical application, such as bacterial infections, inflammatory and rheumatic diseases, pain, hypertension, stroke, AIDS and cancer.

Join us on the new LinkedIn Laboratory Research & Testing group.  This group has been created to learn and share and help you develop new, R&D intensive analytical and bioanalytical approaches to expedite the process of bringing new products to market.  We aspire to create an environment where the brightest academic ideas can be efficiently integrated into a highly regulated drug development framework.

Approximately 95% of all chemicals manufactured today are derived from petroleum so there has been a greater push by government and industry associations to address the environmental impact that these chemicals produce.  In recent years, initiatives have been undertaken to develop biorefinery processes that will create new green chemicals and biopolymers from renewable resources and biomass wastes.

1. DNA profiling by amino acid composition by UPLC:  The enhanced separation ensures that the analysis yields accurate and precise qualitative and quantitative results and that the method is exceptionally rugged. The method, based on the well-understood and widely used AccQ.TagT pre-column derivatization chemistry, provides these benefits in a shorter analysis time than previously achieved by using conventional HPLC methods.  The amino acids are derivatized using AccQ.TagT Ultra Reagent (6-aminoquinolyl-N-hydroxysuccinimidyl carbamate). The derivatives are formed for both primary and secondary amino acids in a simple batch-wise derivatization and are stable for several days.