A Guide to Analytical Method Development

January 24, 2021

A vital component of any successful pharmaceutical development plant is analytical testing, ensuring that the drug being developed does what it is meant to do. Not only do these methods make sure the analyte adheres to individual specifications, but it also ensures that the testing procedures are as effective as the product. 

For all new drug applications (NDAs) and abbreviated new drug applications (ANDAs), an analytical procedure must be described and implemented to verify the drug’s identity, quality, safety, potency, and purity. Not only that, but analysts must assess how a drug is tested to ensure high quality in the manufacturing procedure. 

Manufacturing processes must include procedures that demonstrate how the drug was tested. To gather reliable data and maintain high quality, analytical techniques need to incorporate qualified and calibrated instruments, methods, reference standards, qualified analysts, sample selection integrity, and change control.

What Is Analytical Development?

To determine the composition of a formulation like a new drug, analysts must select the correct criteria and methods for assaying the subject. Throughout the drug development cycle, analytical development assesses specific parameters’ impact on the drug’s quality and performance.

In the beginning stages, analytical methods compare the drug prototype to the Target Product Profile or TPP. The TPP is a document that provides a clear picture of the product’s expectations and objectives.¹

As the process progresses, analytical methods then center on the quality of clinical trial material. Many pharmaceutical companies now outsource drug development to contract development and manufacturing organizations or CDMOs.

CDMOs like BioStem Life Sciences must have a strong partnership and impeccable analytical methods to identify and test the chemical and physical drug characteristics and the assessments used on these products. 

looking through microscope_BioStem lifescience

What Is an Analytical Test Method?

An analytical test method is a series of crucial steps used to test the characteristics of the analyte. To create a test method, analysts must have access to the latest data from previous tests. 

Through a series of steps, analysts collect data and test the identity, strength, purity, quality, and potency of newly created drugs. It is incredibly essential, especially for those companies that outsource to CDMOs, that the original pharmaceutical company and the outsourced manufacturer have clear communication and a strong rapport

How Do You Create an Analytical Method?

To create a useful analytical method development process, you must follow a series of set steps. 

Before embarking into the analytical method, you must first ensure that the instruments used to create and test the subject are calibrated correctly and are high-quality. After the tools have been verified, analysts take the appropriate steps to ensure that useful data can be collected. 

After you have procured and verified the instruments that you need for analysis, you have to identify the purpose, steps, characterizations, requirements, previous methods and literature, analytical method, and more.³ Setting up the instruments and optimization of the method are all integral parts of the process. 

BioStem lifescience analytical development tools

When Should Analytical Methods Be Validated?

The validation of the analytical methods puts a stamp of approval onto the methods used to test the product.

Some of the characteristics validated are specificity, linearity, range, accuracy, precision, detection limit, quantitation limit, and robustness. 

Using these specific parameters, analysts can validate the methods used to analyze any new pharmacopeial or non-pharmacopeial procedures and products. 

The Final Word

For CDMOs and pharmaceutical companies, analytical method development is necessary to create and validate how new products are tested. 

Not only do the products have to meet individual specifications, but the methods used to analyze these products must also comply with strict protocols. 

BioStem Life Sciences is a medical and pharmaceutical company that offers world-class drug development and manufacturing and maintains superb analytical method development. 


(1) Analytical Procedures and Methods Validation for Drugs and Biologics; Guidance for Industry; Availability. (2015, July 27). Retrieved September 25, 2020, from https://www.federalregister.gov/documents/2015/07/27/2015-18270/analytical-procedures-and-methods-validation-for-drugs-and-biologics-guidance-for-industry

(2) Schneider, H., Ph.D., & Webber, K. (2016, July 29). Analytical Method Development: Key to Process Development. Retrieved September 25, 2020, from https://www.americanpharmaceuticalreview.com/Featured-Articles/190687-Analytical-Method-Development-Key-to-Process-Development/

(3) Doltade, M., & Saudagar, R. (2019, June). The Analytical Method Development and Validation: A Review. Retrieved September 25, 2020, from http://jddtonline.info/index.php/jddt/article/view/2774

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