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Literature DB >> 19131992

Quality by design for biopharmaceuticals.

Anurag S Rathore¹, Helen Winkle.

Abstract

Mesh：

Substances：
Biological Products

Year: 2009 PMID： 19131992 DOI： 10.1038/nbt0109-26

Source DB: PubMed Journal: Nat Biotechnol ISSN： 1087-0156 Impact factor: 54.908

× No keyword cloud information.

13 in total

Review 1. Applications of process analytical technology to crystallization processes.

Authors: Lawrence X Yu; Robert A Lionberger; Andre S Raw; Rosario D'Costa; Huiquan Wu; Ajaz S Hussain
Journal: Adv Drug Deliv Rev Date: 2004-02-23 Impact factor: 15.470

Review 2. Current and future issues in the manufacturing and development of monoclonal antibodies.

Authors: Steven Kozlowski; Patrick Swann
Journal: Adv Drug Deliv Rev Date: 2006-05-22 Impact factor: 15.470

3. Application of multivariate analysis toward biotech processes: case study of a cell-culture unit operation.

Authors: Alime Ozlem Kirdar; Jeremy S Conner; Jeffrey Baclaski; Anurag S Rathore
Journal: Biotechnol Prog Date: 2007 Jan-Feb

Review 4. Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics.

Authors: Shalini Gupta; Stephen R Indelicato; Vijay Jethwa; Thomas Kawabata; Marian Kelley; Anthony R Mire-Sluis; Susan M Richards; Bonita Rup; Elizabeth Shores; Steven J Swanson; Eric Wakshull
Journal: J Immunol Methods Date: 2007-01-12 Impact factor: 2.303

5. Process Analytical Technology (PAT): batch-to-batch reproducibility of fermentation processes by robust process operational design and control.

Authors: S Gnoth; M Jenzsch; R Simutis; A Lübbert
Journal: J Biotechnol Date: 2007-04-29 Impact factor: 3.307

6. Pharmaceutical quality by design: product and process development, understanding, and control.

Authors: Lawrence X Yu
Journal: Pharm Res Date: 2008-01-10 Impact factor: 4.200

7. Case study and application of process analytical technology (PAT) towards bioprocessing: use of on-line high-performance liquid chromatography (HPLC) for making real-time pooling decisions for process chromatography.

Authors: Anurag S Rathore; Marcella Yu; Samuel Yeboah; Ashutosh Sharma
Journal: Biotechnol Bioeng Date: 2008-06-01 Impact factor: 4.530

8. Application of multivariate data analysis for identification and successful resolution of a root cause for a bioprocessing application.

Authors: Alime Ozlem Kirdar; Ken D Green; Anurag S Rathore
Journal: Biotechnol Prog Date: 2008-05-10

9. Application of analytical detection concepts to immunogenicity testing.

Authors: Scott L Klakamp; Hong Lu; Mohammad Tabrizi; Cherryl Funelas; Lorin K Roskos; David Coleman
Journal: Anal Chem Date: 2007-10-09 Impact factor: 6.986

10. Overcoming obstacles to monoclonal antibody product development and approval.

Authors: K E Stein
Journal: Trends Biotechnol Date: 1997-03 Impact factor: 19.536

86 in total

Review 1. Immunogenicity to therapeutic proteins: impact on PK/PD and efficacy.

Authors: Narendra Chirmule; Vibha Jawa; Bernd Meibohm
Journal: AAPS J Date: 2012-03-10 Impact factor: 4.009

2. Pharmacogenetics and the immunogenicity of protein therapeutics.

Authors: Chen Yanover; Nisha Jain; Glenn Pierce; Tom E Howard; Zuben E Sauna
Journal: Nat Biotechnol Date: 2011-10-13 Impact factor: 54.908

3. Summary workshop report: Facilitating oral product development and reducing regulatory burden through novel approaches to assess bioavailability/bioequivalence.

Authors: James E Polli; Jack A Cook; Barbara M Davit; Paul A Dickinson; Domenick Argenti; Nancy Barbour; Alfredo García-Arieta; Jean-Marie Geoffroy; Kerry Hartauer; Shoufeng Li; Amitava Mitra; Francis X Muller; Vivek Purohit; Manuel Sanchez-Felix; John W Skoug; Kin Tang
Journal: AAPS J Date: 2012-06-09 Impact factor: 4.009

4. The need for innovation in biomanufacturing.

Authors: Uwe Gottschalk; Kurt Brorson; Abhinav A Shukla
Journal: Nat Biotechnol Date: 2012-06-07 Impact factor: 54.908

Review 5. Approaches to Mitigate the Unwanted Immunogenicity of Therapeutic Proteins during Drug Development.

Authors: Laura I Salazar-Fontana; Dharmesh D Desai; Tarik A Khan; Renuka C Pillutla; Sandra Prior; Radha Ramakrishnan; Jennifer Schneider; Alexandra Joseph
Journal: AAPS J Date: 2017-01-12 Impact factor: 4.009

6. N-terminal glutamate to pyroglutamate conversion in vivo for human IgG2 antibodies.

Authors: Y Diana Liu; Andrew M Goetze; Randal B Bass; Gregory C Flynn
Journal: J Biol Chem Date: 2011-01-31 Impact factor: 5.157

7. Design of experiments-based monitoring of critical quality attributes for the spray-drying process of insulin by NIR spectroscopy.

Authors: Morten Jonas Maltesen; Marco van de Weert; Holger Grohganz
Journal: AAPS PharmSciTech Date: 2012-05-15 Impact factor: 3.246