Apparatus and method for preparative scale purification of...

Chemistry: molecular biology and microbiology – Virus or bacteriophage – except for viral vector or... – Recovery or purification

Reexamination Certificate

Rate now

  [ 0.00 ] – not rated yet Voters 0   Comments 0

Details

C536S023100

Reexamination Certificate

active

10527618

ABSTRACT:
Apparatus and methods are described for pharmaceutical grade manufacture extrachromosomal nucleic acids from cell lysates using flotation to separate and eliminate undesired insoluble cellular debris including chromosomal DNA from the lysates. A gas is introduced to controllably generate bubbles that reduce the density of the cell debris and create a buoyant flocculent phase that can be readily separated from, and thus provide, a substantially clarified fluid lysate phase that is enriched in extrachromosomal DNA but substantially depleted of cellular proteins and chromosomal DNA.

REFERENCES:
patent: 3286992 (1966-11-01), Armeniades et al.
patent: 3928642 (1975-12-01), Hubert et al.
patent: 4450103 (1984-05-01), Konrad et al.
patent: 4462940 (1984-07-01), Hanisch et al.
patent: 4621061 (1986-11-01), Pühler et al.
patent: 4623723 (1986-11-01), Keller et al.
patent: 4780210 (1988-10-01), Hsia
patent: 4830969 (1989-05-01), Holmes
patent: 4900677 (1990-02-01), Hewitt
patent: 4985552 (1991-01-01), Fedeli et al.
patent: 4997932 (1991-03-01), Reardon et al.
patent: 5008189 (1991-04-01), Oroskar et al.
patent: 5034314 (1991-07-01), Geiger et al.
patent: 5057426 (1991-10-01), Henco et al.
patent: 5096818 (1992-03-01), Debonville et al.
patent: 5208160 (1993-05-01), Kikyotani et al.
patent: 5256294 (1993-10-01), Van Reis
patent: 5300433 (1994-04-01), Hrinda et al.
patent: 5561064 (1996-10-01), Marquet et al.
patent: 5576196 (1996-11-01), Horn et al.
patent: 5707812 (1998-01-01), Horn
patent: 5792651 (1998-08-01), Colpan et al.
patent: 5837529 (1998-11-01), Wan et al.
patent: 5916775 (1999-06-01), Hayashizaki
patent: 5981735 (1999-11-01), Thatcher et al.
patent: 5990301 (1999-11-01), Colpan et al.
patent: 6011148 (2000-01-01), Bussey et al.
patent: 6036940 (2000-03-01), Ju et al.
patent: 6197553 (2001-03-01), Lee et al.
patent: 6214586 (2001-04-01), McNeilly
patent: 6268492 (2001-07-01), Mittelstaedt et al.
patent: 6277648 (2001-08-01), Colpan
patent: 6297371 (2001-10-01), Colpan et al.
patent: 6313285 (2001-11-01), Butler et al.
patent: 6492164 (2002-12-01), Crouzet et al.
patent: 6503738 (2003-01-01), Thatcher et al.
patent: 6617443 (2003-09-01), Hendriks et al.
patent: 6664049 (2003-12-01), Chevalier
patent: 6730781 (2004-05-01), Wils et al.
patent: 6750333 (2004-06-01), Kuhne
patent: 6825012 (2004-11-01), Blanche et al.
patent: 2001/0034435 (2001-10-01), Nochumson et al.
patent: 2001/0045359 (2001-11-01), Cheng et al.
patent: 2002/0198372 (2002-12-01), Bridenbaugh et al.
patent: 2474436 (2003-08-01), None
patent: 0 240 191 (1987-10-01), None
patent: 0 376 080 (1990-07-01), None
patent: 0 431 905 (1991-06-01), None
patent: 0 517 515 (1992-12-01), None
patent: WO 99/55837 (1999-11-01), None
patent: WO 98/11208 (1998-03-01), None
patent: WO 98/30685 (1998-07-01), None
patent: WO 99/63076 (1999-12-01), None
Ciccolini et.al. (1999) Bioprocess Engineering 21: 231-237.
Theodossiou et. al. (1999) 20: 147-156.
Levy et. al. (2000) Trends in Biotechnol. vol. 18: 296-305.
Gomez et.al. (2000) Canadian J. of Cehmical Engineering Sciences vol. 78 (4) 785-792.
Kawagoe et. al. (1975) J. of Chemical Engineering of Japan vol. 8 (3) 254-6.
Sridhar et. al. (1980) Industrial & Engineering Chemistry Fundamentals vol. 19 (1) pp. 21-6.
Bioscience Contract Production Corp Flyer, “Plasmid DNA Production,” (Jun. 1999).
Birnboim, et al., “A Rapid Alkaline Extraction Procedure for Screening Recominant Plasmid DNA,” Nucleic Acids Res. 7, 1513-1523 (1979).
Carlson, et al., “Mechanical Description ofEscherichia colifor Plasmid Recovery,” Biotechnology and Bioengineering 48, pp. 303-315 (1995).
Chandra, et al., “Large-Scale Purification of Plasmid DNA by Fast Protein Liquid Chromatography Using a Hi-Load Q Sepharose Column,” Analytical Biochemistry, 203: 169-172 (1992).
Coppella, et al., “Isolation of High-Molecular-Weight Nucleic Acids for copy Number Analysis Using High-Performance Liquid Chromatography,” Journal of Chromatography, 402: 189-199 (1987).
Data Sheet TMAE (M), “Properties of the Tentacle Ion-Exchange Sorbents,” http://www.chromatography.co.uk.products/bio/ds01.htm Aug. 26, 2003.
Davis, et al., Short Technical Reports, “Comparison of Plasmid DNA Preparation Methods for Direct Gene Transfer and Genetic Immunization,” Biotechniques, 21:93-99 (Jul. 1996).
Durland, et al., “Manufacturing and Quality Control of Plasmid-Based Expression Systems,” Advance Drug Delivery Reviews 30: 33-48 (1998) Elsevier.
Ferreira, et al., “Downstream Processing of Plasmid DNA for Gene Therapy and DNA Vaccine Appplications,” Trends in Biotechnology 18, pp. 380-388 (Sep. 2000).
Fractogel EMD Process Media Merck KGaA 8 pages, Sep. 1999.
“Guide to Tentacle-Biochromatography Products,” http:www.chromatography.co.uk/products/bio/summary.htm Aug. 26, 2003.
Horn, et al. “Cancer Gene Therapy Using Plasmid DNA: Purification of DNA for Human Clinical Trials,” Human Gene Therapy, 6: 565-573 (May 1995).
Kahn, et al., “Purification of Plasmid DNA by Tangential Flow Filtration,” Biotechnology and Bioengineering 69(1) 101-106 (2000).
Kenics, “Kenics Static Mixer Systems,” 4 pages Mar. 1, 1995.
Lengsfeld, et al., “Shear-Induced Degradation of Plasmid DNA,” J Pharmaceutical Sciences 91, 1581-1589 (Jul. 2002).
Lesney, “It's Not Being Green?” Today's Chemist at Work, pp. 33-34 (Jul. 2002).
Maniatis, et al., Large-Scale Isolation of Plasmid DNA, Molecular Cloning: A Laboratory Manual, pp. 85, 87, 90 and 91 (1982).
Marquet, et al., “Process Development for the Manufacture of Plasmid DNA Vectors for Use in Gene Therapy,” BioPharm, 8(7) 26-37 (1995).
Marquet, et al., “Characterization of Plasmid DNA Vectors for use in Human Gene Theraphy, Part 1,” BioPharm, 42-50 (May 1997).
Merion, et al., “Purification of Supercoiled Plasmids from Crude Cell Lysates Using High Performance Anion Exchange Chromatography,” BioTechniques 7(1) (1989) 60-67.
Montbriand, et al., “Improved Method for the Removal of Endotoxin From DNA,” Journal of Biotechnology 44: 43-46, (1996).
pAlliance Brochure—QIAGENews, “Contract Plasmid DNA Manufacturing Services for Clinical and Commercial Applications,” Issue No. 2 (2000).
Prazeres, et al., “Large-Scale Production of Pharmaceutical-Grade Plasmid DNA for Gene Therapy: Problems and bottlenecks,” Trends Biotechnol., 17, pp. 169-174 (1999).
Theodassiau, et al. “The Processing of a Plasmid-Based Gene fromE. coli. Primary Recovery by Filtration,” Bioprocess Engineering, vol. 16, (1997) 175-185.
Varley, et al., “Production of Plasmid DNA For Human Gene Therapy Using Modified Alkaline Cell Lysis and Expanded Bed Anion Exchange Chromatography” Bioseparation 8: 209-217 (1999).
“Clearance of Endotoxin From Solution by Absorptive filtration with Wartobind™ Membrane Asorbers,” Sartorius Corporation, Developing Methods #7, SL-4034-E97052 (1997).
Zasloff, et al., “A New Method for the Purification and Idetification of Covalently closed circular DNA Molecules,” Nucleic Acids Research, 5: 1139-1153 (1978).

LandOfFree

Say what you really think

Search LandOfFree.com for the USA inventors and patents. Rate them and share your experience with other people.

Rating

Apparatus and method for preparative scale purification of... does not yet have a rating. At this time, there are no reviews or comments for this patent.

If you have personal experience with Apparatus and method for preparative scale purification of..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Apparatus and method for preparative scale purification of... will most certainly appreciate the feedback.

Rate now

     

Profile ID: LFUS-PAI-O-3958271

  Search
All data on this website is collected from public sources. Our data reflects the most accurate information available at the time of publication.