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Biologics
In addition to Syngene’s expertise in molecular biology, molecular genetics and protein purification, we provide an array of cGMP and non-GMP production services for proteins and antibody products for pre-clinical and clinical Phase I and II material.
Our contract manufacturing services cover cGMP manufacturing and quality control of biopharmaceutical products based on mammalian and microbial expression technologies including: batch, fed-batch, and perfusion technologies.
An experienced Quality Assurance team oversees all aspects of the process, always working closely with clients to ensure regulatory requirements are met. We give intellectual property protection the highest priority by entering into tightly-structured confidentiality agreements. Further, appropriate measures have been put in place for data acquisition, back-up and trending. Access to documents and data is controlled to assure every customer complete confidentiality.
- Process Development & Optimization
- Scale-Up & Tech Transfer
- cGMP Manufacturing
- Analytical & QC
- QA
- Validation
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