CMC DEVELOPMENT
Our Services
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CMC Development
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Our Services Includes
01
Process Development and Optimization
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Optimization services, focusing on both upstream (e.g., cell culture, fermentation) and downstream (e.g., purification, formulation) processes.
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Yield improvement and cost reduction strategies.
02
Formulation Development
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Development and validation of analytical methods for characterizing biologics, mRNA, and gene therapy products.
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Establishing methods for potency, purity, identity, and safety testing
03
Analytical Method Development and Validation
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Identification and optimization of the most suitable formulations for biologics, mRNA, and gene therapy products.
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Development of stable, safe, and effective formulations that maintain product integrity
04
GMP Manufacturing of Clinical and Commercial Batches
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Production of drug substance and drug product under strict GMP conditions
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Scaling up manufacturing processes for commercial production