Bioreactor Contamination

Detect and prevent the introduction of adventitious agents into the bioreactor

Read the most recent papers to protect your upstream process

JX Mascarenhas,N Korokhov,L Burger,A Kassim,J Tuter,D Miller,T Borgschulte,HJ George,A Chang,DJ Pintel,D Onions,KJ Kayser
Biotechnology and bioengineering 2017-12-15
Contamination by the parvovirus minute virus of mice (MVM) remains a challenge in Chinese hamster ovary (CHO) biopharmaceutical production processes. Although infrequent, infection of a bioreactor can be catastrophic for a manufacturer, can impact patient drug supply and safety, and can have regulatory implications. We evaluatedRead More
M Hussain
Journal of pharmaceutical and biomedical analysis 2015-09-21
Chinese hamster ovary (CHO) cells are the host cell of choice for manufacturing of monoclonal antibody (mAb) drugs in the biopharmaceutical industry. Host cell DNA is an impurity of such manufacturing process and must be controlled and monitored in order to ensure drug purity and safety. A conventional method for quantification Read More
B Richards,S Cao,M Plavsic,R Pomponio,C Davies,R Mattaliano,S Madden,K Klinger,A Palermo
PDA journal of pharmaceutical science and technology 2016-10-21
Next-generation sequencing has been evaluated at Genzyme as a means of identifying bioreactor contaminants due to its capability for detection of known and novel microbial species. In this approach, data obtained from next-generation sequencing is used to interrogate databases containing genomic sequences and identities of potenRead More
H Willkommen,J Blümel,K Brorson,D Chen,Q Chen,A Gröner,BR Hubbard,TR Kreil,M Ruffing,S Ruiz,D Scott,G Silvester
PDA journal of pharmaceutical science and technology 2016-10-21
The report provides a summary of the presentations and discussions at the Virus & TSE Safety Forum 2013 organized by the Parenteral Drug Association (PDA) and held in Berlin, Germany, from June 4 to 6, 2013. The conference was accompanied by a workshop, "Virus Spike Preparations and Virus Removal by Filtration: New Trends and DeRead More
TA Grein,R Michalsky,P Czermak
Methods in molecular biology (Clifton, N.J.) 2015-11-19
Industrial manufacturing of cell culture-derived viruses or virus-like particles for gene therapy or vaccine production are complex multistep processes. In addition to the bioreactor, such processes require a multitude of downstream unit operations for product separation, concentration, or purification. Similarly, before a biophRead More
B Hu,J Sellers,J Kupec,W Ngo,S Fenton,TY Yang,A Grebanier
Journal of pharmaceutical and biomedical analysis 2013-11-26
Host cell DNA contamination occurs during the production of biopharmaceuticals and must be controlled and monitored for the purity and safety of the drug products. A sodium iodide-based DNA extraction and a subsequent real time PCR assay were developed and validated for the quantitative measurement of residual host cell DNA impuRead More
Y Qiu,N Jones,M Busch,P Pan,J Keegan,W Zhou,M Plavsic,M Hayes,JM McPherson,T Edmunds,K Zhang,RJ Mattaliano
Biotechnology and bioengineering 2013-03-22
The prevention of adventitious agent contamination is a top priority throughout the entire biopharmaceutical production process. For example, although viral contamination of cell banks or cell cultures is rare, it can result in serious consequences (e.g., shutdown and decontamination of manufacturing facilities). To ensure virusRead More
M Butler,A Meneses-Acosta
Applied microbiology and biotechnology 2013-11-21
The demand for production of glycoproteins from mammalian cell culture continues with an increased number of approvals as biopharmaceuticals for the treatment of unmet medical needs. This is particularly the case for humanized monoclonal antibodies which are the largest and fastest growing class of therapeutic pharmaceuticals. TRead More
LC Hendricks,J Jordan,TY Yang,P Driesprong,GJ Haan,M Viebahn,T Mikosch,H "Van Drunen",AS Lubiniecki
PDA journal of pharmaceutical science and technology 2016-10-21
Out-of-specification (OOS) results were reported by a contract lab in the in vitro adventitious agent assay (AVA) for two products manufactured using mouse myeloma cells in perfusion bioreactors. Cytopathic effect observed for test article-inoculated MRC-5 monolayers resembled foci seen in tissue culture cells infected with tranRead More
MR Bailey,D Chen,WR Emery,PK Lambooy,J Nolting,MT Quertinmont,PA Shamlou
Biotechnology and bioengineering 2008-03-04
Mammalian cell lines constitute an important part in the manufacture of therapeutic proteins. However, their susceptibility to virus contamination is a potential risk to patient safety and productivity, and has led to the development of a repertoire of virus inactivation techniques. From a process development viewpoint, the chalRead More
S Liu,M Carroll,R Iverson,C Valera,J Vennari,K Turco,R Piper,R Kiss,H Lutz
Biotechnology progress 2004-11-17
Commercial bioreactors employing mammalian cell cultures to express biological or pharmaceutical products can become contaminated with adventitious viruses. The high expense of such a contamination can be reduced by passing all gases and fluids feeding the bioreactor through virus inactivation or removal steps, which act as viraRead More
L Domingues,N Lima,JA Teixeira
Biotechnology and bioengineering 2006-11-15
Continuous fermentations were carried out with a recombinant flocculent Saccharomyces cerevisiae strain in an airlift bioreactor. Once operating under steady state at a dilution rate of 0.45 h(-1), the bioreactor was contaminated with Escherichia coli cells. The faster growing E. coli strain was washed out of the bioreactor and Read More
SR Adamson
Developments in biological standardization 2013-11-21
Garnick and coworkers indicated that they experienced two independent MVM outbreaks in a period where approximately 2000 fermentations were performed, hypothesizing that such events were rare but inevitable consequences of very large scale operations. In GIs experience over the last 12 years we have seen no incidence of MVM (or Read More
H Tokuda,K Nakanishi
Bioscience, biotechnology, and biochemistry 2000-12-18
Bacteria cell suspensions were sterilized by direct electric current and the cell death rate was proportional to the current. When repeated hydrolysis of casein by immobilized mycelia was done under 0.06 A of direct electric current, contaminants were inhibited while the hydrolysis was stable for more than 10 batches (250 h).Read More


CA Perkowski
Journal of parenteral science and technology : a publication of the Parenteral Drug Association 2003-11-14
The contamination-free operation of a bioreactor demands constant attention to details. Assuming a well-designed and validated system exists, contamination control requires a skilled operating staff, clear and concise standard operating procedures, ongoing operations review and training, thorough cleaning of equipment, and an efRead More
A Gall-Debreceni,J Lazar,J Kadas,A Balogh,A Ferenczi,E Sos,L Takacs,I Kurucz
Journal of immunological methods 2017-07-20
Monoclonal antibody and recombinant protein production benefits greatly from bovine serum as an additive. The caveat is that bovine serum IgG, co-purifies with mAbs and IgG Fc-containing fusion proteins and it presents a contaminant in the end products. In order to analytically validate the products, species specific reagents arRead More
R Eibl,D Eibl
Advances in biochemical engineering/biotechnology 2009-03-17
In order to increase process efficiency, many pharmaceutical and biotechnology companies have introduced disposable bag technology over the last 10 years. Because this technology also greatly reduces the risk of cross-contamination, disposable bags are preferred in applications in which an absolute or improved process safety is Read More
J Geigert,R Klinke,K Carter,A Vahratian
PDA journal of pharmaceutical science and technology 2016-10-21
If ever clear instruction and close teamwork is needed, it is in the validation of manufacturing processes. All members of the Validation Team need to understand how the Quality Control testing fits into the overall validation work plan. This affords the team members the opportunity to understand how data will be used and avoidsRead More
C "de Wit",C Fautz,Y Xu
Biologicals : journal of the International Association of Biological Standardization 2005-11-17
Chinese hamster ovary (CHO) cells have been widely used to manufacture recombinant proteins intended for human therapeutic uses. Retrovirus-like particles, which are apparently defective and non-infectious, have been detected in all CHO cells by electron microscopy (EM). To assure viral safety of CHO cell-derived biologicals, quRead More
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