CN

Biologics

Healsun Biopharm has 5,000㎡ of GMP production line of DS (Drug Substance) and DP (Drug Product ) in compliance with FDA, EMA, NMPA, and cGMP requirements, providing service of toxicology batch samples for biologics, GMP samples for IND filing and clinical trials.

The annual production capacity for DS can reach up to 20 batches, with each batch being 3,000 grams. For DP, the annual production capacity can reach up to 40 batches, with each batch consisting of 10,000 units.

We can deliver from antibody DNA to toxicology samples within 7 months and fulfill Pre-IND preparation within 12 months.

  • 2 GMP production lines of 250L + 500L, providing flexibility to meet clients' needs
    Disposable technologies of our bioreactors and Storage & distribution systems effectively reduce the risks of (cross-)contamination
    Filling line: 2ml, 10ml, and 20ml
    Sterile filling: automated washing-drying-filling-sealing machine, isolators, disposable storage and dispensing solution and filling system
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