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IND package

IND package

All the works can be accomplished by using a single-source provider that has a well-established, high-quality, flexible, and robust drug development platform across all IND-enabling project phases and CMC activities.

Bioprocess Development

Bioprocess Development

UBP offers an integrated, flexible, and highly customized solution for bioprocess development. Our expertise, with extensive experience in all clinical stages, is dedicated to minimizing the quality, developmental, and regulatory risks over the product lifecycle from preclinical development to commercialization.

GMP Manufacturing

GMP Manufacturing

This state-of-art facility is equipped with two 2,000 L production lines and can be upgraded to 12 of 2,000 L lines. This facility was designed for PIC/S and international GMP compliance. The implementation of FlexFactory® Single-Use Process Technology (GE Healthcare) is flexible and can be easily switched between batches.

Validation

Validation

UBP established a validation system in compliance with global regulations.

Technology platform

Technology platform

De-fucosylation: a de-fucosylation technique to enhance ADCC activity of anti-tumor antibodies

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