Process flow research,
scaling up of production, and manufacturing
Improvement of the synthesis and manufacturing pathways
We study various areas for yield improvement, cost reduction, and productivity improvement of the existing pathways.
We propose improved pathways from the medicinal chemistry pathways.
Scaling up
We conduct synthesis at scales ranging from several hundred grams to a few kilograms based on the laboratory performance.
We develop formulas for plant-scale production based on the laboratory performance, following which NARD Chemicals Ltd. scales up to cGMP-compliant production.
Examinations for impurity
We study the structure of raw materials and intermediate compounds generated during the process and also synthesize derivatives.
We search for analytical methods suitable for tracking reactions and derivative studies.
Process flow development service
We develop processes suitable for production at any development stage (whether GMP or non-GMP compliant). Requests at an early stage allow us to provide consistent-quality products.
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1
Non-clinical study
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2
Ph1, Ph2a
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3
Ph2b, Ph3
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4
PV, application for
regulatory approval
- Synthesis of GLP samples at a 20-L reactor scale
- Proposal of an improved pathway from the medicinal chemistry pathway
- Study of derivative structures (raw materials and process-derived)
- Synthesis of derivatives and fate examinations
- Study of analysis methods suitable for within process flow testing
- Development of GMP-compliant manufacturing processes and pathways
- Optimization of the process flow parameters and validation of thresholds
- Study on the scale-up factors
- Evaluation of the manufacturing safety
- Validation and investigation of appropriate manufacturing costs
- Stable supply
Related contents
Inquiries about products and technologies
Please contact us for consultations and inquiries regarding products and technologies.
