All Research Papers Published In Biologicals

Research Article
22
10.1016/j.biologicals.2020.04.004

Third human challenge trial conference, Oxford, United Kingdom, February 6–7, 2020, a meeting report

Jun 04, 2020
Biologicals
Andrew J Pollard + 32 more +32

Research Article
6
10.1016/j.biologicals.2020.05.001

Potency evaluation of rabies vaccine for human use: The impact of reducing the number of animals per dilution – Part 2

May 22, 2020
Biologicals
Nathalia S Machado + 4 more +4

Research Article
5
10.1016/j.biologicals.2020.04.002

Another case of mistaken identity? Vaccinia virus in another live Camelpox vaccine

Apr 22, 2020
Biologicals
Zack Saud + 1 more +1

Research Article
3
10.1016/j.biologicals.2020.02.001

A next-generation sequencing based method for determining genetic stability in Clostridium tetani vaccine strains

Feb 11, 2020
Biologicals
Jeroen L.a Pennings + 5 more +5

Research Article
7
10.1016/j.biologicals.2020.01.003

Comparison of accompanying proteins in different therapeutic human serum albumin preparations

Jan 21, 2020
Biologicals
Stefan Mikkat + 3 more +3

Research Article
54
10.1016/j.biologicals.2019.12.006

Isolation and characterization of phage (ETP-1) specific to multidrug resistant pathogenic Edwardsiella tarda and its in vivo biocontrol efficacy in zebrafish (Danio rerio)

Dec 27, 2019
Biologicals
Chamilani Nikapitiya + 4 more +4

Research Article
5
10.1016/j.biologicals.2019.10.010

Expression and purification of an immunogenic SUMO-OmpC fusion protein of Salmonella Typhimurium in Escherichia coli

Oct 25, 2019
Biologicals
Prejit + 5 more +5

Research Article
8
10.1016/j.biologicals.2019.10.006

Quality assessment and its impact on clinical performance of a biosimilar erythropoietin: A simulated case study

Oct 25, 2019
Biologicals
Robin Thorpe + 3 more +3

The case study described in this paper was developed for the purpose of training for a better understanding of principles relating especially to a comprehensive evaluation of multiple quality attributes as outlined in the WHO guidelines on evaluation of similar biotherapeutic products. It is also to emphasize the importance of an understanding of the critical quality attributes and a risk assessment of the impact on clinical performance. It was prepared to mimic a real situation in which regulators need to evaluate the differences in quality attributes known to have potential impact on clinical activity. Erythropoietin has been identified as one of the important glycosylated therapeutic proteins and a good example to illustrate how structural characteristics would affect product efficacy and safety. The case study illustrates biosimilarity assessment of a candidate of erythropoietin biosimilar and the important quality attributes that need to be considered in order to understand the importance of structure-function relationships as they contribute to the stepwise evaluation of biosimilarity. This paper reflects the outcomes of the case study exercise and discussion from two WHO implementation workshops held in Ghana (September 2015) and Denmark (July 2017).

Research Article
6
10.1016/j.biologicals.2019.10.005

Use of NMR as an analytical tool in the process development of conjugate vaccines against Haemophilus influenzae type b (Hib) and meningococcal serogroup A (MenA)

Oct 20, 2019
Biologicals
Suresh Beri + 2 more +2

Research Article
4
10.1016/j.biologicals.2019.09.002

Comparison of the liquid and lyophilized formulations of Prolastin®-C for Alpha1-Antitrypsin deficiency: Biochemical characteristics, pharmacokinetics, safety and neoantigenicity in rabbits

Sep 12, 2019
Biologicals
Vikram Arora + 9 more +9