An industry perspective on the monitoring of subvisible particles as a quality attribute for protein therapeutics.
about
Early implementation of QbD in biopharmaceutical development: a practical exampleAggregation of human recombinant monoclonal antibodies influences the capacity of dendritic cells to stimulate adaptive T-cell responses in vitroClassification and characterization of therapeutic antibody aggregates.Recombinant murine growth hormone particles are more immunogenic with intravenous than subcutaneous administrationTherapeutic protein aggregation: mechanisms, design, and control.Aggregation of biopharmaceuticals in human plasma and human serum: implications for drug research and developmentDetection and characterization of subvisible aggregates of monoclonal IgG in serumCrystallization of l-alanine in the presence of additives on a circular PMMA platform designed for metal-assisted and microwave-accelerated evaporative crystallizationTransmission electron microscopy as an orthogonal method to characterize protein aggregates.The Use of Index-Matched Beads in Optical Particle Counters.Analytical characterization of ch14.18: a mouse-human chimeric disialoganglioside-specific therapeutic antibody.Silylated precision particles for controlled release of proteins.Highly aggregated antibody therapeutics can enhance the in vitro innate and late-stage T-cell immune responsesImmunogenicity of different stressed IgG monoclonal antibody formulations in immune tolerant transgenic mice.Improved Stability of a Model IgG3 by DoE-Based Evaluation of Buffer FormulationsAnalytical tools for characterizing biopharmaceuticals and the implications for biosimilars.Strategies for the assessment of protein aggregates in pharmaceutical biotech product developmentQuality attributes of recombinant therapeutic proteins: an assessment of impact on safety and efficacy as part of a quality by design development approach.Protein particulate detection issues in biotherapeutics development--current status.Minimizing immunogenicity of biopharmaceuticals by controlling critical quality attributes of proteins.Biopharmaceutical formulations for pre-filled delivery devices.Accelerated formulation development of monoclonal antibodies (mAbs) and mAb-based modalities: review of methods and tools.Antibody-Drug Conjugates: Design, Formulation and Physicochemical Stability.Characterization of mAb dimers reveals predominant dimer forms common in therapeutic mAbsFactors Governing the Precision of Subvisible Particle Measurement Methods - A Case Study with a Low-Concentration Therapeutic Protein Product in a Prefilled Syringe.Comparative Evaluation of Two Methods for Preparative Fractionation of Proteinaceous Subvisible Particles--Differential Centrifugation and FACS.A Random Forest Approach for Counting Silicone Oil Droplets and Protein Particles in Antibody Formulations Using Flow Microscopy.Two decades of publishing excellence in pharmaceutical biotechnology.Functional evaluation and characterization of a newly developed silicone oil-free prefillable syringe system.Measurement of subvisible particulates in lyophilised Erwinia chrysanthemi L-asparaginase and relationship with clinical experience.The immunogenicity of antibody aggregates in a novel transgenic mouse model.Quantitative laser diffraction method for the assessment of protein subvisible particlesControl of protein particle formation during ultrafiltration/diafiltration through interfacial protection.Characterization of particles in protein solutions: reaching the limits of current technologies.Identification of Subvisible Particles in Biopharmaceutical Formulations Using Raman Spectroscopy Provides Insight into Polysorbate 20 Degradation Pathway.Effects of syringe material and silicone oil lubrication on the stability of pharmaceutical proteins.Towards dynamic control of wettability by using functionalized altitudinal molecular motors on solid surfaces.Small amounts of sub-visible aggregates enhance the immunogenic potential of monoclonal antibody therapeutics.Both protein adsorption and aggregation contribute to shear yielding and viscosity increase in protein solutions.Discrimination between silicone oil droplets and protein aggregates in biopharmaceuticals: a novel multiparametric image filter for sub-visible particles in microflow imaging analysis.
P2860
Q26830466-9031A5E7-0029-42E8-A09E-8BB7CF014068Q28538936-57003805-D79C-49BC-902B-29876EFB203BQ30502491-7024B06A-7326-43FE-8A2C-3F96A5CC4D6FQ34064079-8185A9E5-5EA2-413E-BE70-73FB26B95AC5Q34097620-89BA9A15-A324-49C0-AE01-19B99FD1479FQ34212786-4F138D35-694A-46C1-823D-6D16FC06AA5FQ34216430-E9E9E657-FB6E-4B79-B096-384591F5BF6FQ34573555-92F45718-AD77-4FD4-A17B-318E4C120BA9Q35224074-FDDBC844-2C34-44AC-8A98-CA238D9C9067Q35804399-FC728D44-45A1-4363-836E-FE92D8A3ACF7Q35918866-894B4B06-18E3-4FF6-B239-6C61F1BA4BA5Q35983600-5140A1E1-D0A1-4EED-9166-33FE4E5BC819Q36126960-CF554AB8-52CB-475D-BCCE-5865F721F694Q36411853-24333D14-BBA8-4952-BDCF-D06ED825A1C0Q36693770-0E28E98C-8AF3-4936-BBC4-82B46472B3BDQ37022207-48C6C945-787D-47C2-9128-371FD53BD40AQ37802771-8BAB2642-F93E-4307-9B24-CC6FEDF8B25EQ37999739-11EB9461-B3B2-4EFA-891A-DA587AB7EEDAQ38008257-1427DA6C-4381-4E9F-B025-AFE35EF2F862Q38048706-332A725D-5671-4DBF-AD28-A3831891C1C4Q38090687-E91C4581-FACF-4E9A-90AA-EC362D0E383AQ38313350-7F42D163-2DC3-4442-A55D-82C1E80207F5Q38489049-E76D5274-EA7D-42D7-A495-4104F1F92778Q38887796-4888D44E-4A51-497B-B91F-EF8C4ECDCD94Q38952689-C2C816A1-E2B2-47E7-A0EE-F5F3709E8CB6Q38982627-57CFA686-0554-4C29-8810-AE57C6999D6EQ39084825-82BC3CBE-BB43-4E81-AA0F-294032CE2C1EQ40002920-D22A6F44-8BB1-44CB-A0A7-B5FEE43FD1CEQ40936380-00CDFAC5-FD63-4701-AD73-9586857959C0Q41150769-BFFFEA48-0878-4CBA-B24B-E64B2782E906Q41512850-8893E032-C432-4148-BA71-BAEAD1425896Q41965705-16F57F68-78A1-48E6-9AFB-6EDBB0634915Q42009419-5E880B33-15A4-4652-A775-D1CFED38C24FQ42374083-8D6F0E2F-1BD5-439B-B7F7-0C285C249F8CQ42420872-306FD8E0-1F93-4E5D-8A75-AA7BD8259D64Q43185460-C6955EF5-A0C1-4469-8893-CC8457B9ED3FQ43497789-CAF60595-23E7-4C81-8A64-4F197AD9B5EAQ44285833-6BA2C78B-6AA6-4048-A097-F942064A119EQ44796408-59F9252D-DD26-426F-80AE-9CE4C895F9CDQ44921893-42697FCC-562F-440E-A4DF-6C402E408A14
P2860
An industry perspective on the monitoring of subvisible particles as a quality attribute for protein therapeutics.
description
article científic
@ca
article scientifique
@fr
articolo scientifico
@it
artigo científico
@pt
bilimsel makale
@tr
scientific article published on August 2010
@en
vedecký článok
@sk
vetenskaplig artikel
@sv
videnskabelig artikel
@da
vědecký článek
@cs
name
An industry perspective on the ...... bute for protein therapeutics.
@en
An industry perspective on the ...... bute for protein therapeutics.
@nl
type
label
An industry perspective on the ...... bute for protein therapeutics.
@en
An industry perspective on the ...... bute for protein therapeutics.
@nl
prefLabel
An industry perspective on the ...... bute for protein therapeutics.
@en
An industry perspective on the ...... bute for protein therapeutics.
@nl
P2093
P356
P1476
An industry perspective on the ...... bute for protein therapeutics.
@en
P2093
Brian K Meyer
Danny Chou
Doug P Nesta
Hanns-Christian Mahler
Hans-Juergen Krause
Jeffrey T Blue
Karoline Bechtold-Peters
Linda Narhi
Mary Cromwell
Michel Awwad
P304
P356
10.1002/JPS.22097
P407
P577
2010-08-01T00:00:00Z