Development and production of high-quality products real-time
KriSan Biotech’s capable research and development teams stay with the process through scale-up to ensure a process development and seamless technology transfer from laboratory to manufacturing plant. The state of the art between laboratories and manufacturing as well as the management concept make us an ideal manufacturer for small molecule and peptide.
Focus on customer orientation and project management
KriSan Biotech can provide the speed and flexibility that pharmaceutical companies require when selecting a partner to assist in developing clinical material. Using e-mail and telephone/videoconferencing, KriSan Biotech effectively become an integral part of its customers’ in-house development team.
Facilities & Equipment
KriSan Biotech located in the Southern Taiwan Science Park, has four kilo scale, two mini scale and one peptide product production lines for CGMP manufacturing. Each production line has independent walk-in fume hood, dedicated filter, isolator and vacuum drying oven.
Essentially all of our process equipment was manufactured in the U.S., Europe or Japan. All equipment has been validated to meet international regulatory requirement including:
- Design Qualification(DQ)
- Construction, Installation and Commissioning Qualification (IQ)
- Operation Qualification (OQ)
- Performance and Process Qualification (PQ)
The reactor sizes for kilo scale production line range from 10L to 63L, which should allow for material preparation in the range from hundred grams to about five kilograms; while the reactor sizes for mini scale production line range from 160L to 250L, which should allow for larger scale material preparation and demonstration of process scale-up. These reactors are jacketed with temperature control unit in the range of -60oC to 150oC. All the facilities including supporting equipment are qualified and verified clean prior to use. In addition, Krisan Biotech also has spray dryer and Fitz mill that can provide different product particle size requirement.