As Patents on the biopharmaceuticals, including many blockbusters with over $1 billion in annual sales, have expired or are about to approach expiry, development opportunity of subsequent biosimilars has emerged. And more recently, the researches on the next generation of so-called super-biosimilars are also activated. In this report, we present the optimizations of Protein A capture step for the therapeutic Fc-fusion protein, as one of the super-biosimilars, to improve the yield. The optimizing method was designed by using a design of experiment (DOE) is that statistical tool. The six decision variables used in the optimizations were the component, pH and conductivity of equilibration buffer, residence time (linear velocity), the quantity of loading samples, and pH of elution buffer. After all, an optimized procedure to obtain the therapeutic Fc-fusion proteins was developed.
키워드
Super-biopharmaceuticalsProtein A capture stepFc-fusion protein
저자
Ji-hyun Choi [ Department of Biologics Manufacturing, Korea Biotechnology Commercialization Center, ]
Yong-hoon Chung [ # 2-3, Specializing Research Center, 198-59, Hupyeong-dong, Chuncheon City, Gangwon-do, Korea ]
Joon-Chul Lee [ Department of Biologics Manufacturing, Korea Biotechnology Commercialization Center ]
한국생물공학회 [The Korean Society for Biotechnology and Bioengineering]
설립연도
1984
분야
공학>생물공학
소개
이 법인은 생물 공학의 발전과 보급에 이바지하고, 회원 상호 간의 연구 협력과 친목을 도모함을 목적으로 한다
1. 생물공학 분야의 발전을 위한 연구 협력
2. 생물공학의 실용화를 촉진시키기 위한 산학 협동
3. 학술연구 발표회, 강연회, 연수회 등 학술활동의 개최
4. 국,영문 학술지,소식지,학술회의 Proceedings 및 학술도서의 발간
5. 생물공학 발전을 위한 정책 건의
6. 기타 국제 교류 등 본 학회의 목적 달성을 위한 제반 활동