• Manufacturing

API & Intermediates Manufacturing

Commercial Plants

Anhui Ma’anshan c-GMP Manufacturing Site
  • Total Area：~945,000 ft2
  • 3 GMP production line, scale up to hundreds of kgs per batch, 4 lines in plan
  • Reactors：~170, range from 100L- 8000L
  • Total volume: ~483,000L
ADC & HPAPI GMP Plants
Ma’anshan, Anhui Province — ADC & HPAPI Manufacturing
  • Total area: ~142,000 ft2
  • 5 GMP HPAPI production lines (OEB5, OEL 0.01μg/m3) with a total volume over 4,000L
  • Scale up to kilograms (commercial scale）with multiple prep-HPLC and Lyophilizers
  • Designed with maximum operation efficiency, which include negative pressure isolators to meet operation requirements of the most toxic highly potent APIs
  • Compliant with FDA/EMA/NMPA regulatory standard, passed 1 EU QP audits
Shandong Heze Manufacturing Site
  • Total area: 1,134,500 ft2
  • Reactors: 50, range from 500L - 5,000L; Scale up to hundreds of kgs per batch
  • Total volume: 115,000L
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：~600,000ft²
  • 1 Antibody Line: 200L, 500L, 2000L, reserve a number of 2000L production line
  • 1 Conjugation/ADC DS Line: 50L, 100L, 200L, 300L, 500L
  • 2 DP filling Lines (with Lyophilizer) :10m2, 25m2
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