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Upstream Development

We offer both microbial and mammalian cell culture platforms, which are well-segregated facilities. Each laboratory is fully configurable to meet the client’s requirement. Optimization of cell culture/fermentation process is done using media optimization and control strategies to maximize expression and enhance process reproducibility. We use SCADA software (21 CFR PART 11 COMPLIANCE SOFTWARE) for Data acquisition and storage. We also execute process characterization studies for regulated markets.

Microbial:

The microbial upstream development includes clone screening, media formulation and optimization for microbial systems. The process optimization is done based on physiological requirement of micro organisms in animal source free media. Identification and optimization of fermentation process parameter is executed by using statistical techniques like DOE. The process includes complete metabolite analysis for economic process development and process consistency.

Mammalian:

The mammalian upstream development includes clone screening to get a higher producer clone, preparation of MCB & WCB of the clone and Media selection and optimization at 1L scale to get higher yield using various strategies like feed optimization, cell density optimization, spent media analysis, in-line glyco profile monitoring etc. Process optimization is done at 1L & 5L scale using statistical tools to get robust process. The Process development is carried out at 20L/30L scale. We also perform process characterization studies for regulated markets.

Contact

Plot No. 423 / P / A
Sarkhej - Bavla Highway,
Moraiya, Taluka - Sanand,
Ahmedabad -382 210, Gujarat
India.
Email: Contract.services@intasbiopharma.co.in
Phone#: +91-2717-660100/01
Fax: +91-2717-660105
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