-transparent.png){kind=logo}
We have developed a fermentation process for recombinant human serum albumin (rHSA) production using an expression strain of the methylotrophic yeast Pichia pastoris. The high productivity of the process enables it to compete with the production of plasma derived HSA. After purification of the rHSA, the content of yeast derived contaminants was less than 1 ng/250 mg of rHSA. The results from structural analyses suggested that purified rHSA possessed an identical conformation to plasma derived HSA. Furthermore, no neoantigenicity different from that of plasma derived HSA was observed. The efficacy and safety of rHSA were tested in clinical studies, and it was shown that there was no difference between rHSA and plasma derived HSA in a comparison study. The high efficacy of rHSA with little or no adverse reaction was confirmed in these studies.
K Kobayashi, and
N Nakamura, and
A Sumi, and
T Ohmura, and
K Yokoyama
March 2006,
Biologicals : journal of the International Association of Biological Standardization,
K Kobayashi, and
N Nakamura, and
A Sumi, and
T Ohmura, and
K Yokoyama
August 2007,
Drugs of today (Barcelona, Spain : 1998),
K Kobayashi, and
N Nakamura, and
A Sumi, and
T Ohmura, and
K Yokoyama
August 2009,
Sheng wu yi xue gong cheng xue za zhi = Journal of biomedical engineering = Shengwu yixue gongchengxue zazhi,
K Kobayashi, and
N Nakamura, and
A Sumi, and
T Ohmura, and
K Yokoyama
January 2005,
Journal of clinical pharmacology,
K Kobayashi, and
N Nakamura, and
A Sumi, and
T Ohmura, and
K Yokoyama
May 2002,
Pharmaceutical research,
K Kobayashi, and
N Nakamura, and
A Sumi, and
T Ohmura, and
K Yokoyama
February 2018,
Acta ophthalmologica,
K Kobayashi, and
N Nakamura, and
A Sumi, and
T Ohmura, and
K Yokoyama
January 2010,
Bioscience, biotechnology, and biochemistry,
K Kobayashi, and
N Nakamura, and
A Sumi, and
T Ohmura, and
K Yokoyama
October 1996,
Biotechnology and applied biochemistry,
K Kobayashi, and
N Nakamura, and
A Sumi, and
T Ohmura, and
K Yokoyama
April 1997,
Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan,
K Kobayashi, and
N Nakamura, and
A Sumi, and
T Ohmura, and
K Yokoyama
June 1989,
Biotechnology and applied biochemistry,
