• Manufacturing

API & Intermediates Manufacturing

Commercial Plants

Anhui Ma’anshan c-GMP Manufacturing Site
  • Total Area：~945,000 ft2
  • 1 GMP production line, scale up to hundreds of kgs per batch, 4 lines in plan
  • Reactors：~120, range from 500L- 5000L
  • Total volume: ~320,000L
ADC & HPAPI GMP Plants
Ma’anshan, Anhui Province — ADC & HPAPI Manufacturing
  • Total area : ~80,000 ft2
  • 4 GMP HPAPI production lines, scale up to kgs
  • Total volume : 4,000L
  • Tofflon separator (OEL <0.01μg/m3 ) covering in the full spectrum of HPAPI of pharma
  • SOP controlled exposure: Maximum HPAPI safety is achieved by negative pressure separators for weighing, process development, pre-lyophilization handling. End-to-end production management in controlled working area
  • Scheduled monitoring: Air dust detection and alarm system, continuous staff training (SOP for PPE, emergency response, etc)
Shandong Heze Manufacturing Site
  • Total area: 1,134,500 ft2
  • Reactors: 47, range from 500L - 5,000L; Scale up to hundreds of kgs per batch
  • Total volume: 116,000L
Drug Product
2Y-Biopharma Jiangsu GMP Manufacturing
  • Total area：~139,930 ft2
  • Oral solid dosages: 4 workshops; annual manufacturing capacity: ~1 billion units
  • Semi solid topical dosages: 2 workshop; annual manufacturing capacity: ~ 40 million tubes
  • Solid dispersion: a large scale topical preparation line
  • GMP warehouses of various storage conditions including cold storage
  • Formulation development and manufacturing capabilities include tablets, hard capsules, granules, powders, creams, ointment and gels, including anti-tumor drugs
Chongqing Antibody Drug Conjugate CDMO Manufacturing Site
  • Total Area: 602,000 ft2
  • Protein Related Drug DS: Multiple production scales at 200L, 500L and 2000L
  • 1 DP filling line ; 1 Lyophilization production line
  • 1 Conjugation production line (200L)
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