Development and production of high-quality products
KriSan Biotech’s capable research and development teams stay with the process through research, scale-up, GMP data integrity management 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 GMP management concept make us a qualified manufacturer for small molecule, peptide, oligonucleotide and complex drug substances.
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 six kilo scale production lines from 1 kg to 10 kg of drug substances per batch, also including peptide, and oligonucleotide production capabilities for cGMP manufacturing. Each production line has independent walk-in fume hood, dedicated filter, glove box isolator and vacuum drying oven.
Essentially all equipment has been qualified to meet international regulatory requirement (PIC/S GMP) including:
- Design Qualification(DQ)
- Construction, Installation and Commissioning Qualification (IQ)
- Operation Qualification (OQ)
- Performance and Process Qualification (PQ)
The reactors 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 reactors 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 -60°C to 150°C. All the facilities including supporting equipment are qualified and verified clean prior to use.