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SCALE-UP & PROCESS VALIDATION

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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.

Science Lab

Our Services Includes

01

Process Performance Qualification

  • 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

  • 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

  • Pilot-scale manufacturing services to bridge the gap between small-scale laboratory production and full-scale commercial manufacturing.

  • Scaling up the production process to a pilot scale, allowing companies to produce larger batches for testing, stability studies, and early-stage clinical trials.

  • Identification of any potential scale-up challenges before moving to commercial production.

04

Process Optimization & Parameter Fine-Tuning

  • Optimization and fine-tuning of process parameters during the scale-up phase.

  • Adjusting critical process parameters (CPPs) such as temperature, pH, and agitation rates to ensure the process is robust, reproducible, and scalable.

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ICT Mumbai Research Foundation is set to catalyze innovation in biopharmaceuticals by serving as an accelerator for startups, academia, MSMEs, and industries, providing state-of-the-art infrastructure and expertise for accelerated development of critical therapies for diseases like cancer, rare diseases, and infectious diseases. 

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Get In Touch

+91 81690 53794

Institute of Chemical Technology,
Nathalal Parekh Marg, near Khalsa College, Matunga East, Mumbai, Maharashtra 400019

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