Oligonucleotide Data Analysis with LabSolutions Insight Biologics
The synthetic process can inevitably give rise to impurities, as a result from incomplete synthetic routes, side reactions during manufacturing or from degradation. It is therefore imperative that the desired end product is purified. The purification technique is often dependent on the length and nucleotide base composition. This phase of the oligo life cycle requires robust technology, with user friendly control software, reliability, and good recoveries. Orthogonal chromatography techniques can provide complementary information, such as implementing SFC vs LC. Detection of the oligos is often performed by UV, PDA, fluorescence or by single quadrupole MS for greater peak confirmation or mass directed analysis
For screening, separation of impurities, isolation of main compound, and peak confirmation, use these solutions:
Oligos are complex molecules which must be fully characterised in order to understand the various interactions, sequence confirmation, higher order structures, melting temperatures, and identification of major impurities. Drug metabolism and pharmacokinetics (DMPK) and absorption, distribution, metabolism and excretion (ADME) studies gather crucial information regarding the safety and efficacy of a new therapy in both in vitro and in vivo models. This stage evaluates the mechanisms by which the drug of interest interacts within the body with enzymes, plasma proteins and membrane permeability. These critical stages require analytical instrumentation which is robust, intuitive, adaptable, easy to use as well as sensitive to low quantities of impurities. The breadth of analyses can be covered by several Shimadzu instruments which all have the ingenuity and unique design to facilitate these studies
For quantification, mass confirmation, sequencing, impurity profiling, thermodynamic profiling, concentration and spectrum confirmation, use these solutions:
The quality control phase plays a pivotal role in ensuring the integrity and validity of the end product. Rigorous testing must be performed to guarantee the oligo is the desired final product. This phase requires equipment which can withstand rigorous testing, with easy to control software which can be scrutinised against regulations. The results must be presented in clear to understand formats on instrumentation that is reliable and trustworthy.
For peak confirmation and API profiling, use these solutions:
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