Analytical Toolkit

Good Manufacturing Practice (GMP), along with Good Laboratory Practice (GLP) requires collective efforts of teams from all stages, from concepts and product design to production and post-marketing satisfaction. In this way, following the principles of scalability, reproducibility of mini-scale results to final products will be ensured. It also leads to significant cost savings. To this end, it is essential to plan, design and develop a robust methodology by creating an analytical toolkit for successful operations. Such an approach can reduce deviations and anomalies. Then minimizing risks and costs becomes a realistic goal.

The Methodology - Organizing the Analytical Research

The development of drugs and other biotechnology products requires a proper judgment of their critical quality attributes. In such a way, better management of challenges related to product characterization is achievable including abnormalities, such as lack of activity and specificity. A common practice is the expansion of the analytical description in later steps of the product development. The consequence of such an approach is the accumulation of challenges such as degradations, aggregations, instability, and lack of reproducible results. Besides, it brings a delay in the whole process, which becomes lengthy and costly.

A robust methodology applied to both the sequence and the selection of appropriate analytical tools reduces risks. Prolonged complications related to a process and product can overcome when the focus is on the quality. The reliability assessment should take into account during the development phase. This action depends on the type of procedures under the research and development phases. The team must demonstrate the reliability of the analysis of deliberate changes in the parameters of the method.

The Analytical Toolkit

The development of the analytical toolkit requires a good understanding of the product and the selection of the appropriate tests for analysis. Thus, the guidelines are the best source to start. The four types of analytical procedures as described in Q2 (R1) Guideline Validation of Analytical Procedures: Text and Methodology are:

  • Identification tests
  • Quantitative tests for impurities’ content
  • Limit tests for the control of impurities
  • Quantitative tests of the active moiety in samples of drug substances, drug product or other selected component(s) in the drug product.

Alternative approaches could be accepted by regulatory authorities, notably when more complex biotechnological products are analyzed, such as biopharmaceuticals.

Instrumentarium

Chromatography is the most powerful technique for separation, qualitative and quantitative analysis of biotechnology products. However, HPLC instruments are hard to maintain and generate reliable results. A combination of more low-cost techniques makes it easy to understand data on product properties. Notably, it is beneficial when applying them from the very beginning of the process. This approach enables further selection of appropriate techniques to meet the regulatory requirements. Besides, it expands the analytical spectrum of in-house methods for validation purposes.

At BioGlobaX, we have developed multiple assays for small molecule and biopharmaceutical characterization over the years. We blend low-cost methods with more complex analysis which allows a comprehensive description of the analyte. If you need to establish a robust methodology for analyzing a particular type of compound, do not hesitate to contact us. We will be happy to discuss opportunities to collaborate with you.