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PROCESS DEVELOPMENT

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Lab Experiments

Process Development

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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.

02

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.

Upcoming Events

Biologics Workshop 2025

03

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

04

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.

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