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Investigation of the use of FACS in cell line development

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Nội dung chi tiết: Investigation of the use of FACS in cell line development

Investigation of the use of FACS in cell line development

BIOT1Investigation of the use of FACS in cell line developmentDelfi Krishna and Alexander Taylor, Biopharmaceutical Development, GlaxoSmithKline, 709

Investigation of the use of FACS in cell line development Swede land Road. King of Prussia. PA 19406The economic production of monoclonal antibodies in mammalian cell lines is dependent upon the selection of

high producing cell lines. This process is extremely time, labor and cost consuming. In order to speed up cell line development cycle-times, decrease Investigation of the use of FACS in cell line development

cost of goods and generate higher quality cell lines we have investigated the use of FACS in cell line development protocols. Using a combination of

Investigation of the use of FACS in cell line development

non-static transfection conditions, cell surface staining for secreted recombinant protein and optimized single cell cloning protocols with the BD FAC

BIOT1Investigation of the use of FACS in cell line developmentDelfi Krishna and Alexander Taylor, Biopharmaceutical Development, GlaxoSmithKline, 709

Investigation of the use of FACS in cell line development experience with several different recombinant proteins will be discussed.BIOT 2Development of a Scale-Down Use-Test Model for Mammalian Cell Culture

Raw Material AnalysisSiddhartha Jain. Bernhard Schilling, Abhinav A Shukla, and Steven s Lee, Bristol-Myers Squibb, PO Box 4755, Syracuse, NY 13221Var Investigation of the use of FACS in cell line development

iability in raw materials, both chemically-defined and complex, can significantly impact protein production in mammalian cell culture systems. Underst

Investigation of the use of FACS in cell line development

anding the source of this variability is a key step towards better control of large-scale production processes. A scale-down use-test model was develo

BIOT1Investigation of the use of FACS in cell line developmentDelfi Krishna and Alexander Taylor, Biopharmaceutical Development, GlaxoSmithKline, 709

Investigation of the use of FACS in cell line developmentthe effects of various raw material components on cell growth, cell metabolism and protein production.These studies demonstrated that the occurence of

extraneous compounds at trace levels in cell culture media could result in significant variability in cell culture performance. Some of these compone Investigation of the use of FACS in cell line development

nts can be traced back to the production of cell culture media in stainless steel tanks. This presentation will highlight the role that these trace co

Investigation of the use of FACS in cell line development

mponents can have on large-scale cell culture performance.BIOT 3Head-to-head comparison of production and quality data for Mabs produced in Hyclone 25

BIOT1Investigation of the use of FACS in cell line developmentDelfi Krishna and Alexander Taylor, Biopharmaceutical Development, GlaxoSmithKline, 709

Investigation of the use of FACS in cell line developmentnentech, Inc, 1 Antibody Ufry, Oceanside, CA 92056, Fax: 760-231-2885, Terrence Allotta, allotta.terrence@gene.com, Process Research and Development,

Genentech, Inc, oceanside, CA 92056, Thomas Myint, Process Research and Development, Genentech Inc, Oceanside, CA 92056, and Donna Giandomenico, giand Investigation of the use of FACS in cell line development

omenico.donna@gene.com, Process Development Engineering, Genentech, Inc, So. San Francisco, CA 94080In the processes of setting up a new pilot scale c

Investigation of the use of FACS in cell line development

ell culture facility, 250L Single-Use-Bioreactors (SUBs) were purchased and installed. Operation of the bioreactors was achieved by integrating them w

BIOT1Investigation of the use of FACS in cell line developmentDelfi Krishna and Alexander Taylor, Biopharmaceutical Development, GlaxoSmithKline, 709

Investigation of the use of FACS in cell line developmentss, simplifying the scale-up and data comparison. The SUBs were used in the production of 3 different antibodies produced from CHO cells. For each mol

ecule, product was made using the same processing parameters in the 2L and 250L bioreactors, and the product was subsequently taken through 3 chromato Investigation of the use of FACS in cell line development

graphy steps and analyzed for various indicators of product quality. The SUBs were able to achieve cell culture profiles that were within typical batc

Investigation of the use of FACS in cell line development

h to batch variation at the 2L scale, and product quality was not significantly altered by the transition from 2L bioreactor to the 250L SUB.BIOT 4Hig

BIOT1Investigation of the use of FACS in cell line developmentDelfi Krishna and Alexander Taylor, Biopharmaceutical Development, GlaxoSmithKline, 709

Investigation of the use of FACS in cell line development May Ly, Brandi Dickinson, Gargi Maheshwari, and Shyamsundar Subramaniam. Fermentation and Cell Culture, Bioprocess Research and Development, Merck an

d Co, Inc, 770 Sumneytown Pike, Mail Stop: WP26C-1, West Point. PA 19486Evaluating the impact of complex raw material variability on cell culture proc Investigation of the use of FACS in cell line development

esses is often limited by the analytics that can be performed and the design space where experiments are carried out. Serum is one such raw material t

Investigation of the use of FACS in cell line development

hat is essential in most traditional cell culture-based viral vaccines that use attachment dependent cell substrates (MRC-5, VERO). The composition of

BIOT1Investigation of the use of FACS in cell line developmentDelfi Krishna and Alexander Taylor, Biopharmaceutical Development, GlaxoSmithKline, 709

Investigation of the use of FACS in cell line development(e.g. filtration, fx-irradiation, nutrient supplementation). Given the potential for significant compositional variation between serum-based products

or even individual lots, it is desirable to assess the impact of serum variability on cell culture process steps through a combination of emerging ana Investigation of the use of FACS in cell line development

lytical techniques (e.g. - proteomics, ineiabolomics) and high-throughput experimentation at small-scale to explore a wide design space effectively. I

Investigation of the use of FACS in cell line development

n this study, we used 96-well plate models for experimentation and metabolomics to gain a deeper understanding of how serum variability impacts both c

BIOT1Investigation of the use of FACS in cell line developmentDelfi Krishna and Alexander Taylor, Biopharmaceutical Development, GlaxoSmithKline, 709

Investigation of the use of FACS in cell line developmentf serum variation across several process parameters including serum concentration, heat-treatment and viralmultiplicity of infection (MOI) using đ des

ign of experiments (DOE) approach. To complement these empirical studies, thorough analytical testing of a large database of scrum types using traditi Investigation of the use of FACS in cell line development

onal analytical techniques (e.g. 11PLC or GC-bascd assays) and melabolomics was also undertaken and data mined towards identifying key components inf

Investigation of the use of FACS in cell line development

luencing process performance. These studies determined the extent of process variability resulting from scrum variability, innate and induced from pro

BIOT1Investigation of the use of FACS in cell line developmentDelfi Krishna and Alexander Taylor, Biopharmaceutical Development, GlaxoSmithKline, 709

Investigation of the use of FACS in cell line developmentbody/recombinant protein production where complex raw materials such as hydrolysates are used.BĨOT 5Scale-down challenges for microcarrier-based cell

culture processesTimothy Johnson1, timothy.johnson@genzyme.com, Julie L. Barker1, julie.barker@genzyme.com, Jesse M. Keegan', Daryl St. Laurent', Clau Investigation of the use of FACS in cell line development

dia hi Baser1, claudia.buser@genzyme.com, and Konstantin Konstantinov', konstantin.konstantinov@genzyme.com. (1) BioEngineering. Genzyme Corporation.

Investigation of the use of FACS in cell line development

45 New York Avenue. Framingham. MA 01701, (2) Technology Development. Genzyme Corporation, Framingham, MA 01701Bioreactor scale-up and scale-down char

BIOT1Investigation of the use of FACS in cell line developmentDelfi Krishna and Alexander Taylor, Biopharmaceutical Development, GlaxoSmithKline, 709

Investigation of the use of FACS in cell line development scaling: minimizing shear forces, providing comparable mass transfer, and maintaining equivalent reaction kinetics to name a few. Genzyme's microcarr

ierbased processes add an additional requirement of maximizing the suspension of microcaniers while simultaneously reducing, compared to suspension cu Investigation of the use of FACS in cell line development

ltures, the maximum hydrodynamic forces by two orders of magnitude in order to prevent cell detachment and death. This trade-off becomes problematic u

Investigation of the use of FACS in cell line development

pon scale-down due to increased required rotation rates needed to ensure adequate solids suspension. 1 his presentation will discuss Genzyme's experim

BIOT1Investigation of the use of FACS in cell line developmentDelfi Krishna and Alexander Taylor, Biopharmaceutical Development, GlaxoSmithKline, 709

Investigation of the use of FACS in cell line developmentn in which the microcarrier-cell aggregates can increase significantly in size. Examination of the pilot scale performance at different agitation rate

s and impeller configurations will also be discussed.BIOT 6Twenty-four-well miniature biorcactor system as a scale-down model for cell culture process Investigation of the use of FACS in cell line development

developmentAaron Chen1, chen.aaron@gene.com. Rajesh chitttr. rchitta@kgi.edu. David Chang1. chang.david@gene.com, and Ashraf Amanullah1, amanullah.as

Investigation of the use of FACS in cell line development

hraf@gene.com. (Ì) Oceanside Process Research Sỉ Development, Genentech, Inc, One Antibody Hay,Oceanside, CA 92056, (2) Keck Graduate Institute of App

BIOT1Investigation of the use of FACS in cell line developmentDelfi Krishna and Alexander Taylor, Biopharmaceutical Development, GlaxoSmithKline, 709

Investigation of the use of FACS in cell line developmentor cell culture process development. The microbioreactor system provides high throughput, online monitoring capability and controls for basic process

parameters such as pH, dissolved oxygen (DO), and temperature at the individual well level. M24 utilizes a modified 24-well plate with fluorescent sen Investigation of the use of FACS in cell line development

sor technology which provides a non-invasive method for monitoring pH and DO. In theory each of the 24 wells can be controlled similar to an individua

Investigation of the use of FACS in cell line development

l bioreactor. The M24 combines the advantages of both traditional small and large scales of cell culture vessels; it increases throughput while mainta

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