The ever-growing pharma industry sees the addition of new drugs every day. With the advancements in technology, the market is flooded with medicines claiming to cure every disease there is. This makes it essential for all pharmaceutical products to undergo an analytical method development process. The process helps in efficient drug development and manufacturing and also ensures that the whole process complies with the law. Parmjit Arora’s Health Biotech, one of the leading pharma manufacturers, is rapidly pushing for R&D in analytical method development.
Analytical method development is based on analytical chemistry and includes identifying, separating, and quantifying the chemical components of medicinal compounds. The purpose is to establish the purity and potency of drugs, including their bioavailability and stability. Analytical procedures have been developed to test particular characteristics of the substances against their predefined acceptance criteria. Analytical method development involves evaluating and selecting the most accurate assay procedures to determine the composition of a drug.
“Research and development is an essential aspect of our business strategies that provides a long-term advantage. At Health Biotech, dedicated teams of highly qualified scientists and professionals are engaged in path-breaking research to provide analytical services for all types of drug products,” says Parmjit Arora, Health Biotech Director. Health Biotech offers technology for analytical method development that is in accordance with the regulations and is phase-appropriate and sample-specific.
Analytical procedures play a critical role in risk assessment and management. They help in the establishment of product-specific acceptance criteria and the stability of results. An effective analytical method development also provides significant improvements in precision and a reduction in bias errors. It further helps to avoid costly and time-consuming exercises. The common types of analytical procedures include quantitative tests for impurity content, identification tests, limit tests for impurity control, and quantitative tests for the active moiety in a drug substance or drug product. Analytical method validation is required by regulatory authorities globally for both clinical trial applications and marketing authorizations. Method development is key to having clinical studies approved.
Pharmaceutical analysis plays a significant role in quality assurance as well as quality control of bulk drugs and pharmaceutical formulations. Recent developments in analytical methods are a result of the advancement of analytical instruments. The improvement of analytical tools has resulted in reduced analysis time, increased precision and accuracy, and reduced analysis costs. As a consequence, most pharmaceutical organizations are investing huge amounts of money in the establishment of advanced analytical laboratories.
Every biotechnical company involved in drug product development must make analytical testing one of its major priorities. Analytical development is indispensable to understanding the minute details of a chemical compound’s composition, making the analytic method crucial to the development of new drugs. Analytical development can drastically simplify regulatory compliance, as the authorities will possess clear information about the chemical compounds they are legislating over.