Pharmaceutical Procedure for Analytical Process Development and Validation

Producing biosimilars is quite challenging as drug manufacturers face multiple bottlenecks while ensuring product quality and patient safety. Analytical method development and validation provides the data needed to manufacture safe and valuable drugs. The validation and growth of analytical methods is key to drug development. The biopharma industry has managed to reduce risk by utilising analytical platform technologies for drug conjugates, monoclonal products, and new molecules.

In the pharma industry, validation and analytical characterization are mandatory for quality assurance and quality control. Several drug authorities emphasize on the validation of the processes implemented in the industry. Validation is a systematic and formal way to show the appropriateness of the assay method to offer useful data to ensure the process provides consistent and satisfactory results. 

The procedure for analytical method development is as follows:

1.The objective of analytical method development: Analytical method development provides critical information on the potency, availability, and stability of a drug. Firstly, the objective of conducting this process is established. This is followed by recording and highlighting the steps involved in the process in a laboratory book

2.   Description of the analyte: In this step, the chemical, physical, and biological properties of the analyte are collected. Subsequently, the analyte is acquired and stored based on its particular requirements. The methods for analysis are then verified.

3. Definition of requirements: The requirements for the method development of the analysis are documented and the instruments, reagents, and materials are procured for the evaluation of the sample. 

4.Review of previous methods and literature: All information concerning the specific analyte are reviewed for any chemical and biological properties concerning the analyte. References are made from publications, books, and journals.

5.Select an analytical method: By taking the information attained from the literature, a particular methodology is altered because the practices change with analyte requirements. The procedure carries on without any interruptions if no prior practices are being reviewed concerning the analyte.

6.Setting up instruments:  All the necessary instruments will be set up in the lab-based on standard operating procedures (SOP). These SOPs are often standardized and universal for hassle-free use in a lab setup.

7.Method optimization: While carrying out analytical method optimization, parameters can vary based on evolving interests. Optimization is done in reference to a procedural and systematic plan while punctually following the documented steps.

8.Analytical numbers of documentation: Analytical figures are documented that include analysis time frame, detection limits, quantification limits, and operational costs. The analysis must give a desirable result followed by sample analysis, quantitative demonstration, and sample estimation. 

Diificulties with Analytics Method Development :

Biopharma companies face several challenges with analytical method development which are as follows:

1.The timelines associated with developing a drug are tight and the methods are expected to be comprehensive, regardless of resource changes. To resolve this, the team must work with the cross-functional development team. They must collaborate with managers and be more accessible during the development process.

2.Certain method optimization techniques involve refining method specificity, sensitivity, and revising solution stability. With evolving drug development, critical analytical methods should be optimized regularly for heightened efficiency and yield.

3.Without a direct potency test, you might have to opt for several surrogate test methods for potency. Whenever new methods are used for testing, the focus must be on their optimization, development, and validation.

4.Method validation problems are found before validation studies begin. The primary reason being the lack of comprehension of the molecule’s properties, which is established at the start of the project. Validation studies can only be carried out when the nature of the compound is recognized.