VOLUME 13, ISSUE 2 / JANUARY 2021
Regulatory
DECEMBER 2020
China NMPA perspective on clinical evaluation of SARS-CoV-2 antibody test reagents in the process of emergency approval
- Yunfeng Lv
, - Jingyun He,
- Rongzhi Liu,
- Yu Gao,
- Chao Xu,
- Peng Hu,
- Shengwei Zheng,
- Li Fang,
- Ran Li,
- Congyin Han,
- Juanjuan An &
- Jinchun Dong
- Pages:69–76
- Published Online:16 December 2020
Regulatory
JANUARY 2021
Key points of technical review for the registration of SARS-CoV-2 antigen/antibody tests
- Hongran Li,
- Jingyun He,
- Wen Bao,
- Peirong Wang ,
- Yunfeng Lv ,
- Chao Xu,
- Peng Hu,
- Yu Gao,
- Shengwei Zheng,
- Juanjuan An,
- Gang Deng &
- Jinchun Dong
- Pages:77–88
- Published Online:11 January 2021
Methodology
DECEMBER 2020
Magnetic bead extraction with acid dissociation immunoassay for the determination of serum CD80-Fc fusion protein
- Rosanna Kwok,
- Ago B Ahene ,
- Mason Brown &
- Christopher Hunter
- Pages:89–100
- Published Online:23 December 2020
Research Article
JANUARY 2021
Development of a LC–MS/MS method for the quantification of toxic payload DM1 cleaved from BT1718 in a Phase I study
- Catherine Gowland,
- Philip Berry,
- Julie Errington,
- Phillip Jeffrey,
- Gavin Bennett,
- Lisa Godfrey,
- Marc Pittman,
- Andrew Niewiarowski,
- Stefan N Symeonides &
- Gareth J Veal
- Pages:101–113
- Published Online:26 January 2021
Review
DECEMBER 2020
Considerations in the development and validation of real-time quantitative polymerase chain reaction and its application in regulated bioanalysis to characterize the cellular kinetics of CAR-T products in clinical studies
- Tong-yuan Yang &
- Rajitha Doddareddy
- Pages:115–128
- Published Online:23 December 2020