Analytical Method Development

Development

PROXY uses a systematic approach for the development of analytical methods. This approach usually starts with a feasibility study that checks which critical parameters are relevant. Based on
the results of this study a detailed analytical development plan will be proposed. From the early phases of the drug development trajectory, analytical methods are required by GMP to be properly validated according to ICH guidelines The level of GMP-requirements progressively increase during the developmental stages. Knowledge hereof enables cost-effective drug development. Client/product specific programs can be designed for this purpose.
 
Increasing Regulatory requirements
To ensure the safety of patients participating in clinical trials, authorities tend to increase regulations with progressing scientific insights.
 
Typical examples are:
  1. The control of residual solvents. Since July 2008 it is mandatory in the USP to determine the level of residual solvents in all (bio)pharmaceutical products and raw materials. 
  2. The evaluation of registration dossiers. This evaluation often results in regulatory authorities lowering the upper limits for impurities and requesting characterisation and quantification of impurities at lower levels.
  3. Harmonised methods for microbiological testing require validation, also of products already on the market for numerous years.
PROXY is experienced in helping its customers to stay in compliance with (changing) regulatory requirements. For specific needs regarding residual solvents and impurity profiling, PROXY uses GC-MS and LC-MS techniques, respectively. Standardized packages are available for harmonised microbiological methods.
 
Stability indicating methods
Prior to the initiation of a stability study, analytical methods need to be developed which are able to detect common degradation pathways of (bio)pharmaceutical products. For this purpose PROXY uses a systematic approach in performing forced degradation studies. These studies analyse the influence of chemicals (acids, bases, peroxides), light, temperature and pH on the product and product matrix, as well as the stability of solutions.
 
Available methodology
  • Standard Quality Control methods
  • Standard Microbiological and biochemical methods
  • UPLC-QTOF-MS
  • UPLC-TQD_MS
  • GC-MS
  • CE