Altruist Biologics

Manufacturing operation and capacity

Altruist's Suzhou consists of a gene/cell therapy plant and a multiproduct antibody manufacturing plant. The total capacity for the antibody manufacturing plant is 60,000 liters, Altruist is the CDMO offering the largest number of commercial production batches. The facilities are designed in compliance with FDA, EMA and NMPA standards.

Antibody production factory

Equipped with international standard process equipment, analytical instruments, HAVC system and online monitoring system.

Largest
Commercialized antibody manufacturing
capacity in China
60,000 L
Total capacity

Advantage

Facility standards
Facility standards: The multiproduct facilities are designed to comply with NMPA, FDA, and EMA standards which have passed Chinese GMP inspection and FDA RIE inspection and have been audited/inspected by global biopharmaceutical companies and regulatory agencies.
High success rates of commercialization and technology transfer
Greater than 99% successful rate to ensure on-time delivery to meet client timelines.
Cost control
Good experience in lean operations management and commercialized cost control
Production team
Our team is fully staffed with highly experienced professionals with biopharmaceutical manufacturing and quality management experience.

Manufacturing scale and capacity

DS
Single use Bioreactor and stainless steel Bioreactor: 150 L, 200 L, 500 L, 750 L, 900 L (in construction) , 1,000 L, 3,000 L, 4,500 L (in construction) , 20,000 L (in construction) chromatography system and columns: 400 mm, 1,600 mm, 2,000 mm (in construction)
DP
Two lines for aseptic vial filling with RABS design (include lyophilization process) and one aseptic vial filling line with isolator design (under construction), available vial strength including 2R, 6R, 10R, 15R, 20R, 50R. One aseptic filling line for pre-filled syringe with RABS design, available PFS is 1ml. All filling lines are from international famous brand. Filling volume for each vial is 100% monitored on-line.
Visual inspection
Manual visual inspection and world-class automatic visual inspection.
Packaging
Automatic packaging lines for vials, prefilled syringes and autoinjector, manual packaging is also available.

Visual inspection

Packaging

Single use Bioreactor and stainless steel Bioreactor: 150 L, 200 L, 500 L, 750 L, 900 L (in construction) , 1,000 L, 3,000 L, 4,500 L (in construction) , 20,000 L (in construction) chromatography system and columns: 400 mm, 1,600 mm, 2,000 mm (in construction)

Two lines for aseptic vial filling with RABS design (include lyophilization process) and one aseptic vial filling line with isolator design (under construction), available vial strength including 2R, 6R, 10R, 15R, 20R, 50R. One aseptic filling line for pre-filled syringe with RABS design, available PFS is 1ml. All filling lines are from international famous brand. Filling volume for each vial is 100% monitored on-line.

Manual visual inspection and world-class automatic visual inspection.

Automatic packaging lines for vials, prefilled syringes and autoinjector, manual packaging is also available.