(Q36331505)

13 August 2017

Universal immunoassay applied during early development of large molecules to understand impact of immunogenicity on biotherapeutic exposure (English)

1 reference

13 August 2017

Ami C Bautista

1

1 reference

13 August 2017

Hossein Salimi-Moosavi

series ordinal

2

1 reference

13 August 2017

Vibha Jawa

series ordinal

3

1 reference

13 August 2017

language of work or name

English

0 references

publication date

1 September 2012

1 reference

13 August 2017

1 reference

13 August 2017

14

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13 August 2017

4

1 reference

13 August 2017

843-849

1 reference

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

13 August 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3475848

Immunogenicity of therapeutic proteins: the use of animal models

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3475848

Recommendations for the validation of cell-based assays used for the detection of neutralizing antibody immune responses elicited against biological therapeutics

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3475848

Assessing specificity for immunogenicity assays

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3475848

Pre-clinical considerations in the assessment of immunogenicity for protein therapeutics

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3475848

Roadmap for implementation of quality by design (QbD) for biotechnology products

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3475848

Reducing risk, improving outcomes: bioengineering less immunogenic protein therapeutics

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3475848

Reducing the immunogenicity of protein therapeutics

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3475848

Safety assessment and dose selection for first-in-human clinical trials with immunomodulatory monoclonal antibodies

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3475848

Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3475848

New approaches to prediction of immune responses to therapeutic proteins during preclinical development

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3475848

Prediction of immunogenicity: in silico paradigms, ex vivo and in vivo correlates

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3475848

How to predict and prevent the immunogenicity of therapeutic proteins

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3475848

Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3475848

Preclinical and clinical safety of monoclonal antibodies

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3475848

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

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3475848

An overview of scientific and regulatory issues for the immunogenicity of biological products.

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3475848

Taking immunogenicity assessment of therapeutic proteins to the next level.

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3475848

Rheumatoid factor interference in immunogenicity assays for human monoclonal antibody therapeutics

22 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3475848

Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies

22 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3475848

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

22 September 2018

1 reference

PubMed

https://pubmed.ncbi.nlm.nih.gov/22941399

inferred from PubMed ID database lookup

12 December 2020

based on heuristic

Identifiers

DOI

10.1208/S12248-012-9403-0

1 reference

Dimensions Publication ID

13 August 2017

0 references

1 reference

13 August 2017

PubMed publication ID

22941399

1 reference