Drug Substance Manufacturing
Amaran Biotech’s teams have the technical expertise and knowledge of the necessary standards to execute the manufacturing of complex, high-value drug substances. We have a solid track record of successful delivery of a full spectrum of products with a special focus in the realm of immunotherapy.
Our modern state-of-the-art manufacturing facility features a PIC/S quality system in compliance with global pharmaceutical guidelines such as ICH, USP, and EP. Our facilities are also fully compliant with major regulatory requirements including US FDA, TFDA, and EMA.
Amaran Biotech’s manufacturing capabilities include ozonolysis, thiolation, diafiltration by tangential flow filtration, carbohydrate-protein conjugation, protein and natural product purification and drug substance lyophilization.
- Carbohydrate Synthesis, Protein Glycosylation under lower oxygen level
- Ozonolysis at low-temperature (< -50oC)
- Protein and Natural Product Purification
- Process scale-up and validation