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:
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.