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Are you facing regulatory hurdles in the pharma and biopharma sector?

Learn about bio analysis for new chemical entities

 Pharma and biopharma sectors face numerous challenges as new drugs are being developed across the world. Many companies rely on certified reference material suppliers to sort out reference standards associated with different agencies. They are better at interpreting the guidelines despite of many gaps in various publications and actual analysis.


The alignment for reference standards in the pharmaceutical industry is best understood by SimSon Pharma, a company which is nose-deep in understanding how various reference standards work. It is helping several companies to abide by the regulations successfully.            

The objective of this blog is to help you to understand the best practices for bio analytical methods to validate molecular sizes of drugs. It is useful for clinical and even non-clinical trials and studies. 

Key drivers and focus:

  • Reference standards
  • Reagents like metabolites 
  • Internal standards
  • Regulated bioanalysis for any new chemical entities
  •           Assays to generate primary biomarker data is validated

    How to face the regulatory hurdles effectively? 

    As certified reference material suppliers we recognize the vitality of assay reagents which are required in the process of MV validation. One challenge that seems to be common to most companies is the gap           in Synthesis and the use of materials.


    They refers to: 

    ·         Stock solutions

    ·         Quality control

    ·         Internal standards

    ·         Calibration solution preparations


    Currently the new set of drugs are more complex in their structures. Due to this the standard manual operating procedure within the company and adopting best practices is difficult. This is the current status of reference standards in the pharmaceutical industry: where additional guidelines, variable approaches and policies are required. Companies need to validate biomarker assays which comes under guidelines of BMV recommendations. It is also best to avoid variability from different lots for the study. If it is not possible then the company will have to bridge the gaps for the procedures.

    The BMV process 

    It refers to the performance characteristics and documentation of analytical methods deployed.

    It is done by:


    ·         Spiking blank biological matrix

    ·         Solutions of reference standards are used

    ·         Internal standard chromatographic method is applied

    ·         Quality control samples are derived by metabolites in biological matrix

    ·         Purity of reagents and their identity are vital to the process


    In the case of LBA different reference standards are used. If reference materials of the highest standards are used the results are likely to be better. It should be from the same manufacturing process and batch. It can be used for clinical and non-clinical trials. 

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