Facilities
The SciAnda Changshu facility will be a flexible, multi-product, multi-scale API manufacturing facility. It will be used to produce a variety of bulk APIs. This will also include the capability for process development in small-scale facilities as well as the generation of small quantities of new products for formulation development, clinical trial and commercial sale.
In addition, small-volume high-potency compounds will also be developed / manufactured in the small-scale production unit with capability to handle high-potency compounds with OEL levels as low as 0.003 µg/m3.
Large-scale API production will take place in the five large production plants being built under a Phase II project. The site will contain all necessary support facilities including laboratory, warehouse, maintenance, water purification, and waste treatment.
Manufacturing Capabilities
Phase I facilities and capacities
Category | Production plants | No. of Main reactors | Capacity (Liters) | Total reactor volume (L) |
Small-scale plants | S1/CR1 | 7-G/L, 1-SS | 20-80 | 380 |
Medium scale plants | M1/CR2 | 6-G/L, 1-SS | 300-1,000 | 4,800 |
Large-scale plants | L1 | 5-G/L, 1-SS | 3,000-8,000 | 34,300 |
L2 | 6-G/L, 2-SS | 1,000-6,300 | 38,500 |
· G/L reactor operation range - 19 to 180°C
· SS316 reactor operation range - 196 to 180°C Ultra low temperature reactor
· SS316 reactor operation range - 40 to 180°C
· High potency compound manufacturing: OEL＜1 µg/m3
Phase II facilities and capacities
Category | Production Plants | Reactor Volume (L) | # of Reactor | Total Volume (L) | ||||||||||
Phase IIA | Phase IIB | Phase IIA | Phase IIB | |||||||||||
1 | L3 Plant (most versatile) | 3,000 -16,000 | 10 | -- | 72,000 | -- | ||||||||
2 | L4 Cytotoxics Plant | 4,000 -12,000 | 8 | -- | 46,000 | -- | ||||||||
3 | L5 Plant | 2,000 -16,000 | -- | 8 | -- | 65,000 | ||||||||
4 | L6 Plant | 300 - 10,000 | -- | 8 | -- | 40,300 | ||||||||
5 | L7 Peptide Purification Plant (1F) | 400 -10,000 | -- | 8 | -- | 18,800 | ||||||||
L7 High Potency Plant (2F) | 300 - 3,000 | -- | 6 | -- | 7,300 | |||||||||
| Total | 18 | 30 | 118000 | 131,400 | ||||||||||
| 48 | 249,400 | |||||||||||||
· Phase II equipped with two hydrogenerators, 200L and 1200L at 100 psi
· Physical processing plants equipped with MC300 Jet Mill, and D6A Fitz Mill for particle size reduction to meet customer's requirement on various particle size distribution