PROCESS DEVELOPMENT

Process Development

Mumbai Biocluster excels in process development, focusing on optimizing biopharmaceutical manufacturing processes for scalability and efficiency.

Their expertise ensures streamlined workflows, from early-stage R&D to large-scale production, maximizing product yield and quality.

Our Services Includes

01

Upstream Process Development

Optimization of cell culture conditions, media, and bioreactor parameters.
Development of high-yield, scalable, and reproducible processes for producing biologics, mRNA, and gene therapy products.
Cell line development, media optimization, and scale-up from bench to pilot scale.

Scale-Up and Tech Transfer

Detailed process characterization and optimization studies to identify and control critical process parameters (CPPs) and critical quality attributes (CQAs).
Using design of experiments (DOE) approaches to systematically assess and refine the manufacturing process, ensuring robustness, scalability, and reproducibility.

Process Characterization and Optimization

Scaling up manufacturing processes from laboratory or pilot scale to full commercial scale.
Technology transfer from the development site to manufacturing facilities, ensuring that the process remains consistent and reliable at larger scale

Downstream Process Development

Purification and recovery of the target product from the cell culture.
Optimizing chromatography, filtration, and other purification steps to ensure high purity and yield of the final product.

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Avenir Light is a clean and stylish font favored by designers. Avenir Light is a clean and stylish font favored by designers.

Avenir Light is a clean and stylish font favored by designers. Avenir Light is a clean and stylish font favored by designers.