SCALE-UP & PROCESS VALIDATION
Scale-Up & Process Validation
Mumbai Biocluster provides comprehensive scale-up solutions, transitioning bioprocesses from lab to commercial production while maintaining product integrity. Their process validation services ensure that manufacturing processes meet regulatory standards, supporting long-term product stability.
Our Services Includes
01
Process Performance Qualification
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Process Performance Qualification (PPQ) studies during the pilot phase to validate that the scaled-up process consistently produces product batches that meet predetermined quality criteria.
03
Technology Transfer & Scale-Up Support
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Technology transfer services to ensure that the scaled-up process is successfully transferred from the development lab to the pilot or commercial manufacturing facility.
02
Pilot-Scale Manufactuting
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Pilot-scale manufacturing services to bridge the gap between small-scale laboratory production and full-scale commercial manufacturing.
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Scaling up the production process to a pilot scale, allowing companies to produce larger batches for testing, stability studies, and early-stage clinical trials.
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Identification of any potential scale-up challenges before moving to commercial production.
04
Process Optimization & Parameter Fine-Tuning
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Optimization and fine-tuning of process parameters during the scale-up phase.
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Adjusting critical process parameters (CPPs) such as temperature, pH, and agitation rates to ensure the process is robust, reproducible, and scalable.