Method Development

Posted by Lgmpharma on November 21st, 2022

What is the relevance of analytical method development in API manufacturing process?

Owing to the ever-increasing cost, legal restrictions as well as competitive environment while bringing new pharmaceutical products into the market, drug makers are facing enormous challenges. Due to this, pharmaceutical companies are being increasingly focusing on accelerating the developmental cycles, at the same time ensuring the highly effective & sure shot route towards commercialization. Based on that, analytical method development is holding crucial importance, assisting out in creating the optimum environment as well as conditions for producing new molecules and proving the acceptability of such methods owing to their intended purpose. So, in nutshell, the method development will be ensuring that all the laboratory resources will get optimized and this specific methodology is capable of meeting the goals during every stage of drug development.

The analytical method development is key towards successful commercialization

The majority of the APIs will be requiring a method for the purpose of assaying, purity profile, and residual solvent. Every process will be requiring a method development releasing of the raw material as well as the IPC (in-process control) of the samples. Creating a specific analytical method development procedure will be requiring a few of key steps, starting with a determination of the type of procedure being developed.

The strategic approach to method development brings upon savings in time as well as cost

The analytical method development is undeniably one of the most crucial steps in API manufacturing. Not only it is needing some sort of senior-level expertise, however. FDA (Food and Drug Administration), US is also raising its bar about the regulatory needs along with its strong analytical capabilities, which is acting as a key differentiator. So, now that pharmaceutical companies can concentrate on their core activities, the strategic approach to method development and validation adopted by the company brings upon time as well cost savings.