Experiences with HEK293: a human cell line

MJ Rubino - PDA Journal of Pharmaceutical Science and …, 2010 - journal.pda.org
The paper describes considerations taken with regard to a recombinant human cell line
(HEK293) producing a therapeutic protein. When working with HEK293 cells, besides …

Virus Removal and Inactivation: A Decade of Validation Studies: Critical Evaluation of the Data Set

JK Walter, F Nothelfer, W Werz - 1998 - ACS Publications
Recombinant DNA technology as well as hybridoma technology provide an outstanding
opportunity for the preparation of complex human proteins with significant impact on …

Mammalian cell lines used in bioprocessing

N ERGEN, H TÜFEKÇİ - Journal of Experimental and Clinical …, 2022 - dergipark.org.tr
Various number of expression and host systems are used in biologics manufacturing. The
most commonly preferred systems are based on bacteria, yeast, mammalian cells, insect …

Human cell lines for biopharmaceutical manufacturing: history, status, and future perspectives

J Dumont, D Euwart, B Mei, S Estes… - Critical reviews in …, 2016 - Taylor & Francis
Biotherapeutic proteins represent a mainstay of treatment for a multitude of conditions, for
example, autoimmune disorders, hematologic disorders, hormonal dysregulation, cancers …

Manufacture of pharmaceutical proteins from hybridomas and other cell substrates.

WR Tolbert, RG Rupp - Developments in Biological Standardization, 1989 - europepmc.org
Murine monoclonal antibodies are now routinely produced from highly expressing
hybridoma cell lines for human clinical applications. Epstein Barr Virus transformed human …

Molecular characterization of HEK293 cells as emerging versatile cell factories

M Pulix, V Lukashchuk, DC Smith… - Current opinion in …, 2021 - Elsevier
Highlights•Manufacture of biopharmaceuticals, virus-like particles and viral vectors.•System
biology,'omics, cellular phenotype and cell engineering.•Cell line development, culture and …

Validation of the purification process for viral clearance evaluation

AJ Darling - BIOPROCESS TECHNOLOGY, 2000 - books.google.com
Throughout the history of biologics administered for human use, one can find numerous
examples of products that have been contaminated with potential hu-man pathogens. The …

An academic centre for gene therapy research with clinical grade manufacturing capability

KB Islam, P Blomberg, K Wikström… - Annals of …, 1997 - Taylor & Francis
Huddinge University Hospital is a major teaching hospital affiliated with the Karolinska
Institute in Southern Stockholm. For the past few years several groups have been working …

Influence of HEK293 metabolism on the production of viral vectors and vaccine

E Petiot, M Cuperlovic-Culf, CF Shen, A Kamen - Vaccine, 2015 - Elsevier
Mammalian cell cultures are increasingly used for the production of complex
biopharmaceuticals including viral vectors and vaccines. HEK293 is the predominant cell …

[CITATION][C] Process validation for virus removal and inactivation.

EM White, JB Grun, CS Sun, AF Sito - BioPharm, 1991