Yokogawa Fluid Imaging Technologies' distributor to India's Biopharmaceutical market is Bioscreen Instruments. Bioscreen's Field Application Specialist, Jamuna Yadhav, shared with us the following testimonial and case study about their experience using the FlowCam to analyze injectable drug samples.
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"Today’s requirement in biopharmaceuticals in the injectable sector is to understand the characteristic features of the sub-visible particulates. The challenge is to clearly demark and distinguish the types of particles existing in the sample which have an adverse effect in downstream processing. The existing methods of light obscuration cannot distinguish the protein aggregates, whereas the combination of microscopy and flow analysis in the FlowCam makes it superior to the traditional methods.
Our experiences in India during demonstration sessions have given us tremendous knowledge in the applications of the FlowCam system for injectables. We were able to distinguish the silicone oil vs. the air bubbles and globular protein vs fibrous protein.
The flow imaging technology provided by the FlowCam (with its particle characterizing properties being the highlight of the system along with high-resolution particle images) has been one of the most useful tools in analysing and distinguishing these particles.
Case study:
In the sample run and analysis for a customer, the FlowCam was helpful in differentiating the characteristic feature of particles in injectables. The sample run was analysed using VisualSpreadsheet software. Different libraries of silicone oil, aggregates and air bubbles were generated. The sample data was analysed using the libraries as per USP788 guidelines for different particle sizes. These libraries created were helpful in differentiating the particles and particle counts of aggregates verses oil. This is an added advantage of the FlowCam: to look at data with a different perspective.
The FlowCam could become a preeminent tool for scientists in analysing injectables and finding the root cause of increased silicone and aggregates in samples. It also opens up the market for the need of analysing every injectable with the FlowCam technology and hopefully will become part of process development across the biopharmaceutical market.
From the demonstrations conducted so far, customers have emphasized the best features of the FlowCam being:
- Low sample volume usage
- High quality image analysis
- Different particle characterizing properties
- Ease of software handling with reference libraries
- Analysis of particles as per USP 788 guidelines.
We at Bioscreen Instruments Pvt Ltd are delighted to represent Fluid Imaging Technologies in the Indian biopharma market."
Jamuna Yadhav R, M.Sc, PGDB (bioinformatics)
Field Application Specialist
