top of page

CMC DEVELOPMENT

Science Lab ai generated image

CMC Development

At Mumbai Biocluster, Chemistry, Manufacturing, and Controls (CMC) development is critical to ensuring the safety, efficacy, and consistency of biopharmaceutical products. They specialize in developing robust CMC strategies that align with regulatory guidelines, accelerating time-to-market.

Science Lab

Our Services Includes

01

Process Development and Optimization

  • Optimization services, focusing on both upstream (e.g., cell culture, fermentation) and downstream (e.g., purification, formulation) processes.

  • Yield improvement and cost reduction strategies.

02

Formulation Development

  • Development and validation of analytical methods for characterizing biologics, mRNA, and gene therapy products.

  • Establishing methods for potency, purity, identity, and safety testing

03

Analytical Method Development and Validation

  • Identification and optimization of the most suitable formulations for biologics, mRNA, and gene therapy products.

  • Development of stable, safe, and effective formulations that maintain product integrity 

04

GMP Manufacturing of Clinical and Commercial Batches

  • Production of drug substance and drug product under strict GMP conditions

  • Scaling up manufacturing processes for commercial production

bottom of page