The Challenges in Analytical Method Development and Validation

The Challenges in Analytical Method Development and Validation


Manufacturing biologics is not an easy task as drug companies face several challenges while safeguarding patient safety and product quality.
Analytical testing offers the data required to produce effective and safe drugs. The growth and validation of analytical methods is key to drug
development. The biopharma industry has successfully reduced risk by adopting analytical platform technologies for monoclonal products,
drug conjugates, and new molecules.
Several methods such as FDA’s Quality-by-Design (QbD) initiative can have a positive impact on validation and
analytical method development because the procedures are identified early in the development process.

Challenges Associated with Analytical Method Development and Validation
The challenges bio pharma companies face with analytical method development and validation are as follows:

 Often the timelines for developing a drug are tight. However, sufficient consideration is not given to validation and analytical method
development. People expect analytical methods to be complete, irrespective of resource changes or timeline. To overcome this
challenge, the analytical development team must work closely with the cross-functional development team. This will help them
anticipate changes and participate actively in all discussions concerning the timeline. The analytical development team must
instruct and collaborate with project managers and be more visible when the development process is taking place.

 If initial studies are positive for the drug’s intended use, method optimization has to be included. Some of the common
method optimization technique involves refining method sensitivity, specificity, and revising solution stability. With progressing
drug development, the critical analytical methods of the regulatory submission must be optimized constantly for increased
efficiency and yield.


Several patient-specific vaccines need a unique approach theoretically in that few test methods must be carried out for
non-patient-specific consistency against patient-specific critical quality traits. Without a direct potency test, you might
have to opt for several surrogate test methods for potency. Whenever new methods are used for testing, focus must be
on their optimization, development, and validation.

Analytical Method Development and Validation issues are often found even before the start of validation studies.
The key reason is a lack of comprehension of the molecule’s physicochemical properties, which is determined at the
onset of the project. These include establishing the molecule’s pH, solubility, reactivity, pKA, melting and boiling point,
light and moisture sensitivity and other features. Validation studies can be designed when the physiochemical nature
of the compound is decisively recognized. 

Drug companies must formulate and review all analytical methods developed. Eventually, methods will undergo
validation through peer and QA review followed by a regulatory review. Effective analytical method development
guarantees that lab resources are enhanced and the methods created can be validated at each subsequent step. If
any modifications are needed, the changes must be documented before moving to the next step.


Lack of effective communication is another major challenge in analytical method development and validation.
Either there will be certain techniques that one facility uses that the other facility does not or there is key
information which is not kept in the analytical method. One major issue is ensuring that the right message is
sent, across both sides and the key information for a positive transfer is communicated. 

A strong analytical method requires validation as per the guidelines set by the FDA. The parameters included in
analytical method validations are based on test category. The most important parameters are linearity, specificity,
range, accuracy, precision, quantitative, and limit of detection.

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