Unlike most independent API producers, whose facilities are often retrofitted older plants purchased from pharmaceutical or speciality chemical companies, ScinoPharm's multi-purpose, multi-product facility, located in the Southern Taiwan Science Park, was specifically designed to incorporate the best features of modern API facilities surveyed from around the world.
The conceptual design was reviewed by the USFDA prior to the commencement of construction. In 2001, 2005, 2008 and 2012, ScinoPharm's completed facility was inspected by FDA and given a "suitable" facility rating.
Our production facilities consist of 16 units (18 cGMP lines) for production ranging from kilograms to multiple tons. Reactor sizes range from 50 liters to 10,000 liters and materials range from stainless to glassed-lined to hastelloy. Four units are considered large suites, three are intermediate in size and 11 are considered small units. Six lines are capable of cytotoxic/high potency production with total containment and properly segregated air and physical systems. All 16 units have their own dedicated filtration/drying/milling/and packaging facilities. Several multiple-use drying and finishing units are available to reduce intermediate bottlenecks and all have been validated for API/CGMP operations. All process and utility systems are fully automated using a Fisher Rosemont Delta V process automation system.
Tainan, Taiwan Facility
The ScinoPharm Taiwan 16.5 acre main process R&D and manufacturing facility is located in the Tainan Science-based Industrial Park in southern Taiwan. It is one of the largest non-brand facilities of its kind in the world with more than 200,000 square feet of space and approximately 315 employees. The facility has received satisfactory audit results from 15 major international customers.
The broad array of chemical reactors ranging from very small to very large provides the flexibility to conduct a wide variety of chemical processes. This offers the capability to meet customers' requirements in any size range. All phases of operations will adhere to stringent international quality, environmental, health and safety requirements and will be in full compliance with international CGMP standards.
Changshu, China Facility
ScinoPharm (ChangShu) Pharmaceutical Ltd. takes two phases of facility construction, commissioning and qualification. Phase I contains small and middle production lines, S1 and M1. Both S1 and M1 are capable to hand high potent compound with lowest OEL 0.003 μg/m3. Phase 2 contains one peptide purification plant, one high potency plant, one physical property processing plant and 4 production Bays, L3A, L3B, L4 and L5 which will provide large quantity of API with different PSD for customer demand.
The ScinoPharm Changshu facility is to be a flexible, multi-product, API manufacturing facility. It will be used to produce a variety of bulk APIs. This will include the capability for process development in small scale facility as well as the generation of small quantities of new products being evaluated for production and sale. Small-volume high-potency compounds will also be developed in small scale facility. The site will contain all necessary support facilities including laboratory, warehouse, maintenance, water purification, and waste treatment.