Early implementation of QbD in biopharmaceutical development: a practical example (Q26830466)

biomedical investigative technique

main subject

1 reference

19 September 2019

Ingmarie Höidén-Guthenberg

11

0 references

author name string

Jesús Zurdo

1

1 reference

Andreas Arnell

2

1 reference

Olga Obrezanova

3

1 reference

Noel Smith

4

1 reference

Ramón Gómez de la Cuesta

5

1 reference

Thomas R. A. Gallagher

6

1 reference

Rebecca Michael

7

1 reference

Yvette Stallwood

8

1 reference

Caroline Ekblad

9

1 reference

Lars Abrahmsén

10

1 reference

language of work or name

1 reference

2015

1 reference

BioMed Research International

17 May 2015

3 references

19 September 2019

22 August 2022

7 February 2024

4 references

19 September 2019

22 August 2022

7 February 2024

2015

1 reference

page(s)

605427

1 reference

Creative Commons Attribution 3.0 Unported

copyright license

3 references

Europe PubMed Central

19 September 2019

Europe PubMed Central

22 August 2022

ELISA and multiplex technologies for cytokine measurement in inflammation and aging research

Europe PubMed Central

7 February 2024

0 references

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Comparison of the three-dimensional structures of a humanized and a chimeric Fab of an anti-gamma-interferon antibody

7 April 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Identification and multidimensional optimization of an asymmetric bispecific IgG antibody mimicking the function of factor VIII cofactor activity

7 April 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Aggregation of human recombinant monoclonal antibodies influences the capacity of dendritic cells to stimulate adaptive T-cell responses in vitro

7 April 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

TGN1412: From Discovery to Disaster

7 April 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Can the pharmaceutical industry reduce attrition rates?

7 April 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412

7 April 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Preclinical and early clinical development of GNbAC1, a humanized IgG4 monoclonal antibody targeting endogenous retroviral MSRV-Env protein

7 April 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012.

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Assessment of chemical modifications of sites in the CDRs of recombinant antibodies: Susceptibility vs. functionality of critical quality attributes

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Clinical development success rates for investigational drugs

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

T-cell dependent immunogenicity of protein therapeutics: Preclinical assessment and mitigation

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Developability studies before initiation of process development: improving manufacturability of monoclonal antibodies

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Albumin as a versatile platform for drug half-life extension

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Clinical testing for neutralizing antibodies to interferon-β in multiple sclerosis

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

GLP2-2G-XTEN: a pharmaceutical protein with improved serum half-life and efficacy in a rat Crohn's disease model

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Minimizing immunogenicity of biopharmaceuticals by controlling critical quality attributes of proteins

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

High-dose monoclonal antibodies via the subcutaneous route: challenges and technical solutions, an industry perspective.

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Antibody-mediated pure red cell aplasia in chronic kidney disease patients receiving erythropoiesis-stimulating agents: new insights

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Multidimensional methods for the formulation of biopharmaceuticals and vaccines.

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Aggregates in monoclonal antibody manufacturing processes

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

28 September 2017

Natalizumab (Tysabri)

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Post-translational modifications of protein biopharmaceuticals

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

An industry perspective on the monitoring of subvisible particles as a quality attribute for protein therapeutics

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

The safety and side effects of monoclonal antibodies

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Stability of protein pharmaceuticals: an update

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Adverse drug reactions to biologics

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

PEGylation of therapeutic proteins

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Mechanisms of adverse drug reactions to biologics

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Pharmacological significance of glycosylation in therapeutic proteins

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Formulation and manufacturability of biologics

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Quality by design for biopharmaceuticals

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Principles, approaches, and challenges for predicting protein aggregation rates and shelf life

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Engineering of a femtomolar affinity binding protein to human serum albumin

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Cetuximab-induced anaphylaxis and IgE specific for galactose-alpha-1,3-galactose

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Heterogeneity of monoclonal antibodies

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Protein aggregation and bioprocessing

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Effects of protein aggregates: an immunologic perspective

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Computational models for the prediction of polypeptide aggregation propensity

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

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

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Theoretical approaches to protein aggregation

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Rational design of aggregation-resistant bioactive peptides: reengineering human calcitonin

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Prediction of "aggregation-prone" and "aggregation-susceptible" regions in proteins associated with neurodegenerative diseases

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Polypeptide models to understand misfolding and amyloidogenesis and their relevance in protein design and therapeutics.

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Controlled-release and local delivery of therapeutic antibodies

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Structure-immunogenicity relationships of therapeutic proteins

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Challenges in the development of high protein concentration formulations

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Minimizing the immunogenicity of protein therapeutics

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Identification of B- and T-cell epitopes of BB, a carrier protein derived from the G protein of Streptococcus strain G148.

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Aggregation risk prediction for antibodies and its application to biotherapeutic development

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Engineering a therapeutic IgG molecule to address cysteinylation, aggregation and enhance thermal stability and expression

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Weak interactions govern the viscosity of concentrated antibody solutions: high-throughput analysis using the diffusion interaction parameter

31 May 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Tungsten-induced denaturation and aggregation of epoetin alfa during primary packaging as a cause of immunogenicity

31 May 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Primate testing of TGN1412: right target, wrong cell

31 May 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Trial watch: phase II and phase III attrition rates 2011-2012.

31 May 2018

1 reference

https://api.crossref.org/works/10.1155%2F2015%2F605427

Prediction of protein retention in ion-exchange systems using molecular descriptors obtained from crystal structure.

21 January 2018

1 reference

https://api.crossref.org/works/10.1155%2F2015%2F605427

3D structure-based protein retention prediction for ion-exchange chromatography

21 January 2018

1 reference

https://api.crossref.org/works/10.1155%2F2015%2F605427

High-throughput self-interaction chromatography: applications in protein formulation prediction

21 January 2018

1 reference

https://api.crossref.org/works/10.1155%2F2015%2F605427

High-throughput dynamic light scattering method for measuring viscosity of concentrated protein solutions

21 January 2018

1 reference

https://api.crossref.org/works/10.1155%2F2015%2F605427

High throughput formulation screening for global aggregation behaviors of three monoclonal antibodies

21 January 2018

1 reference

https://api.crossref.org/works/10.1155%2F2015%2F605427

Viscosity of high concentration protein formulations of monoclonal antibodies of the IgG1 and IgG4 subclass - prediction of viscosity through protein-protein interaction measurements.

21 January 2018

1 reference

https://api.crossref.org/works/10.1155%2F2015%2F605427

Viscosity measurements of antibody solutions by photon correlation spectroscopy: an indirect approach - limitations and applicability for high-concentration liquid protein solutions

21 January 2018

1 reference

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Sustained Intraocular Pressure Elevation After Intravitreal Injection of Bevacizumab and Ranibizumab Associated with Trabeculitis

21 January 2018

1 reference

https://api.crossref.org/works/10.1155%2F2015%2F605427

Erythropoietin-Associated PRCA: Still an Unsolved Mystery

21 January 2018

1 reference

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Structure-based engineering of a monoclonal antibody for improved solubility

21 January 2018

1 reference

https://api.crossref.org/works/10.1155%2F2015%2F605427

Predicting the expression of recombinant monoclonal antibodies in Chinese hamster ovary cells based on sequence features of the CDR3 domain.

21 January 2018

1 reference

https://api.crossref.org/works/10.1155%2F2015%2F605427

A home infliximab infusion program

21 January 2018

1 reference

https://api.crossref.org/works/10.1155%2F2015%2F605427

Native-state solubility and transfer free energy as predictive tools for selecting excipients to include in protein formulation development studies

21 January 2018

1 reference

https://api.crossref.org/works/10.1155%2F2015%2F605427

Taking immunogenicity assessment of therapeutic proteins to the next level.

21 January 2018

1 reference

https://api.crossref.org/works/10.1155%2F2015%2F605427

Immunogenicity screening in protein drug development

21 January 2018

1 reference

https://api.crossref.org/works/10.1155%2F2015%2F605427

Clinical validation of the "in silico" prediction of immunogenicity of a human recombinant therapeutic protein.

21 January 2018

1 reference

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Comparison of novel methods for predicting the risk of pro-inflammatory clinical infusion reactions during monoclonal antibody therapy.

21 January 2018

1 reference

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Antibody against poly(ethylene glycol) adversely affects PEG-asparaginase therapy in acute lymphoblastic leukemia patients

21 January 2018

1 reference

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Autoantibodies to variable heavy (VH) chain Ig sequences in humans impact the safety and clinical pharmacology of a VH domain antibody antagonist of TNF-α receptor 1.

21 January 2018

1 reference

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Optimization of a human IgG B-cell ELISpot assay for the analysis of vaccine-induced B-cell responses

21 January 2018

1 reference

https://api.crossref.org/works/10.1155%2F2015%2F605427

Potential aggregation-prone regions in complementarity-determining regions of antibodies and their contribution towards antigen recognition: a computational analysis

21 January 2018

1 reference

https://api.crossref.org/works/10.1155%2F2015%2F605427

Prediction of aggregation-prone regions in structured proteins

21 January 2018

1 reference

https://api.crossref.org/works/10.1155%2F2015%2F605427

High molecular weight polyethylene glycol cellular distribution and PEG-associated cytoplasmic vacuolation is molecular weight dependent and does not require conjugation to proteins

21 January 2018

1 reference

https://api.crossref.org/works/10.1155%2F2015%2F605427

Developability assessment as an early de-risking tool for biopharmaceutical development

21 January 2018

1 reference

https://api.crossref.org/works/10.1155%2F2015%2F605427

Identification of multiple sources of charge heterogeneity in a recombinant antibody.

21 January 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4449898

Formulation Development of Therapeutic Monoclonal Antibodies Using High-Throughput Fluorescence and Static Light Scattering Techniques: Role of Conformational and Colloidal Stability

28 November 2018

1 reference

12 December 2020

Predicting cytokine storms: it's about density

1 reference

12 December 2020

Developability index: a rapid in silico tool for the screening of antibody aggregation propensity

1 reference

12 December 2020

Assessment of net charge and protein-protein interactions of different monoclonal antibodies

1 reference

12 December 2020

A simple whole blood bioassay detects cytokine responses to anti-CD28SA and anti-CD52 antibodies

1 reference

12 December 2020

Cardiopulmonary arrest after severe anaphylactic reaction to second infusion of infliximab in a patient with ankylosing spondylitis

1 reference

12 December 2020

Computational methods to predict therapeutic protein aggregation

1 reference

12 December 2020

"Cytokine storm" in the phase I trial of monoclonal antibody TGN1412: better understanding the causes to improve preclinical testing of immunotherapeutics

1 reference

12 December 2020

Bispecific Affibody Molecules for Targeting of EGFR and HER2

1 reference

https://api.crossref.org/works/10.1155%2F2015%2F605427

7 January 2021

inferred from DOI database lookup

Design of protein-binding proteins from the target structure alone

1 reference

9 October 2024

https://opencitations.net/index/api/v1/citations/10.1038/S41586-022-04654-9

Identifiers

1 reference

1 reference

PubMed publication ID

26075248

1 reference