(Q34918193)

5 August 2017

title

Quality by design for biopharmaceuticals (English)

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5 August 2017

1

Anurag S Rathore

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5 August 2017

Helen Winkle

2

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5 August 2017

publication date

1 January 2009

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5 August 2017

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5 August 2017

volume

27

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5 August 2017

issue

1

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5 August 2017

page(s)

26-34

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https://scigraph.springernature.com/pub.10.1038/nbt0109-26

5 August 2017

exact match

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cites work

Application of analytical detection concepts to immunogenicity testing

1 reference

12 December 2020

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

1 reference

12 December 2020

Current and future issues in the manufacturing and development of monoclonal antibodies

1 reference

12 December 2020

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

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12 December 2020

Overcoming obstacles to monoclonal antibody product development and approval

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12 December 2020

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

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12 December 2020

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

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12 December 2020

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

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12 December 2020

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

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12 December 2020

Applications of process analytical technology to crystallization processes

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12 December 2020

Defining process design space for biotech products: case study of Pichia pastoris fermentation.

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12 December 2020

Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products

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12 December 2020

Validation and implementation of drug-dependent antibody assays in clinical trials for safety monitoring of patients dosed with roxifiban, an orally bioavailable glycoprotein IIb/IIIa antagonist

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12 December 2020

Identifiers

DOI

10.1038/NBT0109-26

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5 August 2017

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