Abstract:
:To manufacture biotechnology products, mammalian or bacterial cells are engineered for the production of recombinant therapeutic human proteins including monoclonal antibodies. Host cells synthesize an entire repertoire of proteins which are essential for their own function and survival. Biotechnology manufacturing processes are designed to produce recombinant therapeutics with a very high degree of purity. While there is typically a low residual level of host cell protein in the final drug product, under some circumstances a host cell protein(s) may copurify with the therapeutic protein and, if it is not detected and removed, it may become an unintended component of the final product. The purpose of this article is to enumerate and discuss factors to be considered in an assessment of risk of residual host cell protein(s) detected and identified in the drug product. The consideration of these factors and their relative ranking will lead to an overall risk assessment that informs decision-making around how to control the levels of host cell proteins.
journal_name
Biotechnol Bioengjournal_title
Biotechnology and bioengineeringauthors
de Zafra CL,Quarmby V,Francissen K,Vanderlaan M,Zhu-Shimoni Jdoi
10.1002/bit.25647subject
Has Abstractpub_date
2015-11-01 00:00:00pages
2284-91issue
11eissn
0006-3592issn
1097-0290journal_volume
112pub_type
杂志文章abstract::There has been a recent drive in commercial large-scale production of biotechnology products to convert current batch mode processing to continuous processing manufacturing. There have been reports of model systems capable of adapting and linking upstream and downstream technologies into a continuous manufacturing pip...
journal_title:Biotechnology and bioengineering
pub_type: 杂志文章,评审
doi:10.1002/bit.26060
更新日期:2017-01-01 00:00:00
abstract::Rapid advances in intensifying upstream processes for biologics production have left downstream processing as a bottleneck in the manufacturing scheme. Biomanufacturers are pursuing continuous downstream process development to increase efficiency and flexibility, reduce footprint and cost of goods, and improve product...
journal_title:Biotechnology and bioengineering
pub_type: 杂志文章,评审
doi:10.1002/bit.26812
更新日期:2018-12-01 00:00:00
abstract::Alkyl beta-D-glucosides were synthesized from D-glucose and alcohols by reverse hydrolysis using the commercially available almond beta-D-glucosidase in 9:1 (v/v) acetonitrile-water medium. The main characteristics of this enzyme-catalyzed glucosylation were established by using 2-hydroxybenzyl alcohol. The reaction i...
journal_title:Biotechnology and bioengineering
pub_type: 杂志文章
doi:10.1002/bit.260460204
更新日期:1995-04-20 00:00:00
abstract::A model is proposed that accounts for the decreases in yield which occur in chemostat cultures of mesophilic yeasts at superoptimal growth temperatures. Two yield depressing effects were identified, one due to increased maintenance requirements by the viable fraction of the population, the other due to energy substrat...
journal_title:Biotechnology and bioengineering
pub_type: 杂志文章
doi:10.1002/bit.260180603
更新日期:1976-06-01 00:00:00
abstract::Non-destructive label-free continuous monitoring of in vitro tissue culture is an unmet demand in tissue engineering. Noting that different compositions of cartilage lead to different electrical tissue properties, we propose a new method to measure the electrical conductivity and its anisotropy during in vitro chondro...
journal_title:Biotechnology and bioengineering
pub_type: 杂志文章
doi:10.1002/bit.25350
更新日期:2015-02-01 00:00:00
abstract::Sugarcane bagasse is an abundant and sustainable resource, generated as a by-product of sugarcane milling. The cellulosic material within bagasse can be broken down into glucose molecules and fermented to produce ethanol, making it a promising feedstock for biofuel production. Mild acid pretreatment hydrolyses the hem...
journal_title:Biotechnology and bioengineering
pub_type: 杂志文章
doi:10.1002/bit.24984
更新日期:2013-12-01 00:00:00
abstract::Pretreatment of high-crystalline cellulose with N-methyl-morpholine-N-oxide (NMO or NMMO) to improve bioethanol and biogas production was investigated. The pretreatments were performed at 90 and 120 degrees C for 0.5-15 h in three different modes, including dissolution (85% NMO), ballooning (79% NMO), and swelling (73...
journal_title:Biotechnology and bioengineering
pub_type: 杂志文章
doi:10.1002/bit.22558
更新日期:2010-02-15 00:00:00
abstract::The Chinese hamster ovary (CHO) cell line producing interferon-gamma (IFN-gamma) exhibits a 2-fold increase in specific productivity when grown at 32 degrees C compared to 37 degrees C. Low temperature also causes growth arrest, meaning that the cell density is significantly lower at 32 degrees C, nutrients are consum...
journal_title:Biotechnology and bioengineering
pub_type: 杂志文章
doi:10.1002/bit.10861
更新日期:2004-01-20 00:00:00
abstract::A packed granular activated carbon (GAC) biobed, inoculated with the ethane-degrading strain Mycobacterium E3, was used to study ethene removal from a synthetic waste gas. Ethene, for which the dimensionless partition coefficient for an air-water system at 20 degrees C is about 7.6, was used as a model compound for po...
journal_title:Biotechnology and bioengineering
pub_type: 杂志文章
doi:10.1002/bit.260440511
更新日期:1994-08-20 00:00:00
abstract::A starvation-based dissolved oxygen (DO) transient controller was developed to supply growth-limiting substrate to high cell density fed-batch cultures of recombinant Escherichia coli. The algorithm adjusted a preexisting feed rate in proportion to the culture's oxygen demand, which was estimated from transients in th...
journal_title:Biotechnology and bioengineering
pub_type: 杂志文章
doi:10.1002/bit.10802
更新日期:2004-02-20 00:00:00
abstract::A transient, two-culture model simulating methane production from biomass has been developed. The simulator, based partially on the work by Andrews and McCarty, is capable of calculating the hydrolysis products of several common organic materials, accommodating various substrate feeding modes, and simulating the trans...
journal_title:Biotechnology and bioengineering
pub_type: 杂志文章
doi:10.1002/bit.260240903
更新日期:1982-09-01 00:00:00
abstract::A means of rapidly renaturing denatured protein was devised and evaluated. Three liquids were laminarly layered in a centrifuge tube, in which two solutions sandwiched liquid paraffin so as to form a pseudolipid bilayer. Denatured and aggregted protein placed on the upper surface of liquid paraffin was renatured as it...
journal_title:Biotechnology and bioengineering
pub_type: 杂志文章
doi:10.1002/bit.260430108
更新日期:1994-01-05 00:00:00
abstract::The effect of hydrogen and carbon dioxide partial pressure on the growth of the extremely thermophilic archaebacterium Pyrodictium brockii at 98 degrees C was investigated. Previous work with this bacterium has been done using an 80:20 hydrogen-carbon dioxide gas phase with a total pressure of 4 atm; no attempt has be...
journal_title:Biotechnology and bioengineering
pub_type: 杂志文章
doi:10.1002/bit.260320405
更新日期:1988-08-05 00:00:00
abstract::Chinese hamster ovary (CHO) cells in culture are known to consume large amounts of nutrients and divert most of them toward byproducts, some of which, including lactate and ammonia, are known to be toxic in nature. Glucose limitation strategies can successfully control lactate accumulation in fed-batch cultures yieldi...
journal_title:Biotechnology and bioengineering
pub_type: 杂志文章
doi:10.1002/bit.26313
更新日期:2017-08-01 00:00:00
abstract::In this study, the inhibitory effects and anaerobic biotransformation of acrylic acid in computer-controlled pH-stat completely stirred tank reactors (CSTRs) with two different cultures, namely unacclimated and acrylate-acclimated acetate-enriched Methanosarcina and homogenized (crushed) granular cultures, were invest...
journal_title:Biotechnology and bioengineering
pub_type: 杂志文章
doi:10.1002/(sici)1097-0290(19990120)62:2<200::aid-bit
更新日期:1999-01-20 00:00:00
abstract::This study demonstrated that hydrogen-producing acidogenic sludge could agglutinate into granules in a well-mixed reactor treating a synthetic sucrose-containing wastewater at 26 degrees C, pH 5.5, with 6 h of hydraulic retention. A typical matured granule is 1.6 mm in diameter, 1.038 g/mL in density, 11% in ash conte...
journal_title:Biotechnology and bioengineering
pub_type: 杂志文章
doi:10.1002/bit.10174
更新日期:2002-04-05 00:00:00
abstract::trans-4-Hydroxy- l-proline (Hyp) is an abundant component of mammalian collagen and functions as a chiral synthon for the syntheses of anti-inflammatory drugs in the pharmaceutical industry. Proline 4-hydroxylase (P4H) can catalyze the conversion of l-proline to Hyp; however, it is still challenging for the fermentati...
journal_title:Biotechnology and bioengineering
pub_type: 杂志文章
doi:10.1002/bit.26818
更新日期:2019-01-01 00:00:00
abstract::Numerous biotechnological production processes are based on the submerse cultivation of filamentous fungi. Process design, however, is often hampered by the complex growth pattern of these organisms. In the morphologic development of coagulating filamentous fungi, like Aspergillus niger, conidial aggregation is the fi...
journal_title:Biotechnology and bioengineering
pub_type: 杂志文章
doi:10.1002/bit.21569
更新日期:2008-02-01 00:00:00
abstract::Protein dynamic binding capacities on ion exchange resins are typically expected to decrease with increasing conductivity and decreasing protein charge. There are, however, conditions where capacity increases with increasing conductivity and decreasing protein charge. Capacity measurements on two different commercial ...
journal_title:Biotechnology and bioengineering
pub_type: 杂志文章
doi:10.1002/bit.21080
更新日期:2006-12-05 00:00:00
abstract::Isothermal microcalorimeters (IMC) are highly sensitive instruments that allow the measurement of heat flow in the microwatt range. Due to their detection of minute thermal heat, IMC techniques have been used in numerous biological applications, including the study of fermentation processes, pharmaceutical development...
journal_title:Biotechnology and bioengineering
pub_type: 杂志文章
doi:10.1002/bit.23268
更新日期:2011-12-01 00:00:00
abstract::The fim inversion system of Escherichia coli (E. coli) can behave as a unidirectional switch in an efficient manner. We have developed a new expression system for E. coli, comprising the arabinose-inducible fimE gene and the fim invertible DNA segment containing a constitutively active promoter. In this system, the ta...
journal_title:Biotechnology and bioengineering
pub_type: 杂志文章
doi:10.1002/bit.20916
更新日期:2006-05-05 00:00:00
abstract::There is strong evidence in the literature supporting the existence of significant mass transfer limitations on the kinetics of exogenous H(2) consumption by methanogens. The half saturation constant for H (2) uptake by a mixed-culture, CH(4) producing enrichment was measured using an experimental protocol that avoide...
journal_title:Biotechnology and bioengineering
pub_type: 杂志文章
doi:10.1002/bit.260400704
更新日期:1992-10-05 00:00:00
abstract::The damaging and degenerative effects in autoimmune diseases such as rheumatoid arthritis, multiple sclerosis and Crohn's disease often manifests as the formation of lesions that feature a high local concentration of granulocyte-macrophage colony-stimulating factor (GM-CSF). GM-CSF along with other pro-inflammatory fa...
journal_title:Biotechnology and bioengineering
pub_type: 杂志文章
doi:10.1002/bit.26523
更新日期:2018-04-01 00:00:00
abstract::Surface modified bioactive glass with surface properties akin to those of the bone mineral phase is an attractive candidate for use as a microcarrier material for 3-D growth of bone-like tissue in rotating wall vessel bioreactors (RWVs). The critical surface properties of this material are the result of reaction in so...
journal_title:Biotechnology and bioengineering
pub_type: 杂志文章
doi:10.1002/bit.10023
更新日期:2001-11-05 00:00:00
abstract::Pichia pastoris, a methylotrophic yeast, is an efficient producer of recombinant proteins in which the heterologous gene is under the control of the methanol-induced AOX1 promoter. Hence, the accepted production procedure has two phases: In the first phase, the yeast utilizes glycerol and biomass is accumulated; in th...
journal_title:Biotechnology and bioengineering
pub_type: 杂志文章
doi:10.1002/bit.10587
更新日期:2003-05-20 00:00:00
abstract::Lignocellulosic biofuels and chemicals have great potential to reduce our dependence on fossil fuels and mitigate air pollution by cutting down on greenhouse gas emissions. Chemical, thermal, and enzymatic processes are used to release the sugars from the lignocellulosic biomass for conversion to biofuels. These proce...
journal_title:Biotechnology and bioengineering
pub_type: 杂志文章,评审
doi:10.1002/bit.27639
更新日期:2020-11-26 00:00:00
abstract::Hydrogel membranes have been fabricated that incorporate antibody/antigen moieties. The permeability of large solutes through these membranes is dependent on the presence of soluble antigen that can compete with the internal interactions between antibody and antigen leading to an increase in gel mesh size. Specificall...
journal_title:Biotechnology and bioengineering
pub_type: 杂志文章
doi:10.1002/bit.21255
更新日期:2007-07-01 00:00:00
abstract::The effects of growing Clostridium acetobutylicum NCIB 8052 in a chemostat under conditions of glucose, NH(4) (+), PO(4) (3-), Mg(2+), and Fe(2+) limitation were examined. It was noted that limitation of any major nutrient resulted in the same fermentation pattern. Conditions where minor nutrient levels were reduced a...
journal_title:Biotechnology and bioengineering
pub_type: 杂志文章
doi:10.1002/bit.260290315
更新日期:1987-02-01 00:00:00
abstract::We have studied the growth rate dependence of hepatitis B surface antigen (HBsAg) p24(s) monomer and lipoprotein particle synthesis produced in Saccharomyces cerevisiae using galactose-limited continuous culture. The hepatitis B virus S gene, which encodes the p24(s) monomer, is transcribed under the control of the GA...
journal_title:Biotechnology and bioengineering
pub_type: 杂志文章
doi:10.1002/(SICI)1097-0290(19960305)49:5<578::AID-BIT
更新日期:1996-03-05 00:00:00
abstract::The development of a lentiviral system to deliver genes to specific cell types could improve the safety and the efficacy of gene delivery. Previously, we have developed an efficient method to target lentivectors to specific cells via an antibody-antigen interaction in vitro and in vivo. We report herein a targeted len...
journal_title:Biotechnology and bioengineering
pub_type: 杂志文章
doi:10.1002/bit.22378
更新日期:2009-09-01 00:00:00