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Consulting - GMP related biopharmaceutical products process development and manufacturing
- Expression system design (protein, peptide expression in Prokaryotes and Eukaryotes)
- Process and analytical development (protein, peptide, and antibodies)
- GMP manufacturing (protein, peptide, antibodies, DNA, vaccine, viral vectors, and antibiotics)
- Facility and equipment requirements for GMP production
- Facility and equipment validation for GMP production
- Documentation preparation (SOP, batch record preparation and reviewing; CMC and IND documentation preparation and reviewing)
- Troubleshootings
Contract Manufacturing - GLP and GMP production of bio-products for animal studies and clinical trials (Phase I, II)
- Process and analytical development
- cGMP cell bank preparation
- Process scale up and scale down
- Pilot scale production and purification
- Bacterial
- Yeast
- Insect and Mammalian cells
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