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An Industry Perspective on the Monitoring of Subvisible Particles as a Quality Attribute for Protein Therapeutics

Journal of pharmaceutical sciences, 2010-08, Vol.99 (8), p.3302-3321

2010

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Influence of particle shedding from silicone tubing on antibody stability

Journal of pharmacy and pharmacology, 2018-05, Vol.70 (5), p.675-685

2018

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Classification of protein aggregates

Journal of pharmaceutical sciences, 2012-02, Vol.101 (2), p.493-498

2012

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Particle Shedding from Peristaltic Pump Tubing in Biopharmaceutical Drug Product Manufacturing

Journal of pharmaceutical sciences, 2015-04, Vol.104 (4), p.1440-1450

2015

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Preservative loss from silicone tubing during filling processes

European journal of pharmaceutics and biopharmaceutics, 2017-03, Vol.112, p.109-118

2017

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Analysis of thin baked-on silicone layers by FTIR and 3D-Laser Scanning Microscopy

European journal of pharmaceutics and biopharmaceutics, 2015-10, Vol.96, p.304-313

2015

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The effect of mAb and excipient cryoconcentration on long-term frozen storage stability – Part 1: Higher molecular weight species and subvisible particle formation

International journal of pharmaceutics: X, 2022-12, Vol.4, p.100108-100108, Article 100108

2022

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The effect of mAb and excipient cryoconcentration on long-term frozen storage stability – part 2: Aggregate formation and oxidation

International journal of pharmaceutics: X, 2022-12, Vol.4, p.100109-100109, Article 100109

2022

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The silicone depletion in combination products induced by biologics

European journal of pharmaceutics and biopharmaceutics, 2024-10, Vol.203, p.114418, Article 114418

2024

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Impact of autoclavation on baked-on siliconized containers for biologics

European journal of pharmaceutics and biopharmaceutics, 2023-06, Vol.187, p.184-195

2023

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Evaluation of a novel silicone oil free primary packaging system with PTFE-based barrier stopper for biologics

European journal of pharmaceutics and biopharmaceutics, 2023-09, Vol.190, p.206-219

2023

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Raman Marker Bands for Secondary Structure Changes of Frozen Therapeutic Monoclonal Antibody Formulations During Thawing

Journal of pharmaceutical sciences, 2023-01, Vol.112 (1), p.51-60

2023

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Not the Usual Suspects: Alternative Surfactants for Biopharmaceuticals

ACS applied materials & interfaces, 2023-07, Vol.15 (29), p.34540-34553

2023

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Modular and tunable alternative surfactants for biopharmaceuticals provide insights into Surfactant's Structure-Function relationship

International journal of pharmaceutics, 2024-01, Vol.650, p.123692-123692, Article 123692

2024

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Visualisation and Quantification of Subcutaneous Injections of Different Volumes, Viscosities and Injection Rates: An Ex-Vivo micro-CT Study

Journal of pharmaceutical sciences, 2024-09

2024

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Industry Perspective on the use and Characterization of Polysorbates for Biopharmaceutical Products Part 1: Survey Report on Current State and Common Practices for Handling and Control of Polysorbates

Journal of pharmaceutical sciences, 2022-05, Vol.111 (5), p.1280-1291

2022

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Scaling Down Large-Scale Thawing of Monoclonal Antibody Solutions: 3D Temperature Profiles, Changes in Concentration, and Density Gradients

Pharmaceutical research, 2021-11, Vol.38 (11), p.1977-1989

2021

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Industry Perspective on the Use and Characterization of Polysorbates for Biopharmaceutical Products Part 2: Survey Report on Control Strategy Preparing for the Future

Journal of pharmaceutical sciences, 2022-11, Vol.111 (11), p.2955-2967

2022

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Computational fluid dynamic simulations of temperature, cryoconcentration, and stress time during large-scale freezing and thawing of monoclonal antibody solutions

European journal of pharmaceutics and biopharmaceutics, 2022-08, Vol.177, p.107-112

2022

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Cryoconcentration and 3D Temperature Profiles During Freezing of mAb Solutions in Large-Scale PET Bottles and a Novel Scale-Down Device

Pharmaceutical research, 2020-09, Vol.37 (9), p.179-179, Article 179

2020

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Risk-based approach to setting sterile filtration microbial bioburden limits – Focus on biotech-derived products

European journal of pharmaceutics and biopharmaceutics, 2024-05, Vol.198, p.114151-114151, Article 114151

2024

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An Intra-Company Analysis of Inherent Particles in Biologicals Shapes the Protein Particle Mitigation Strategy Across Development Stages

Journal of pharmaceutical sciences, 2023-05, Vol.112 (5), p.1476-1484

2023

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Silicone Migration From Baked-on Silicone Layers. Particle Characterization in Placebo and Protein Solutions

Journal of pharmaceutical sciences, 2016-12, Vol.105 (12), p.3520-3531

2016

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Replacing the Emulsion for Bake-on Siliconization of Containers-Comparison of Emulsion Stability and Container Performance in the Context of Protein Formulations

PDA journal of pharmaceutical science and technology, 2022-03, Vol.76 (2), p.89-108

2022

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New FDA Draft Guidance on Immunogenicity

The AAPS journal, 2014-05, Vol.16 (3), p.499-503

2014

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An Industry Perspective on the Monitoring of Subvisible Particles as a Quality Attribute for Protein Therapeutics

Influence of particle shedding from silicone tubing on antibody stability

Classification of protein aggregates

Particle Shedding from Peristaltic Pump Tubing in Biopharmaceutical Drug Product Manufacturing

Preservative loss from silicone tubing during filling processes

Analysis of thin baked-on silicone layers by FTIR and 3D-Laser Scanning Microscopy

The effect of mAb and excipient cryoconcentration on long-term frozen storage stability – Part 1: Higher molecular weight species and subvisible particle formation

The effect of mAb and excipient cryoconcentration on long-term frozen storage stability – part 2: Aggregate formation and oxidation

The silicone depletion in combination products induced by biologics

Impact of autoclavation on baked-on siliconized containers for biologics

Evaluation of a novel silicone oil free primary packaging system with PTFE-based barrier stopper for biologics

Raman Marker Bands for Secondary Structure Changes of Frozen Therapeutic Monoclonal Antibody Formulations During Thawing

Not the Usual Suspects: Alternative Surfactants for Biopharmaceuticals

Modular and tunable alternative surfactants for biopharmaceuticals provide insights into Surfactant's Structure-Function relationship

Visualisation and Quantification of Subcutaneous Injections of Different Volumes, Viscosities and Injection Rates: An Ex-Vivo micro-CT Study

Industry Perspective on the use and Characterization of Polysorbates for Biopharmaceutical Products Part 1: Survey Report on Current State and Common Practices for Handling and Control of Polysorbates

Scaling Down Large-Scale Thawing of Monoclonal Antibody Solutions: 3D Temperature Profiles, Changes in Concentration, and Density Gradients

Industry Perspective on the Use and Characterization of Polysorbates for Biopharmaceutical Products Part 2: Survey Report on Control Strategy Preparing for the Future

Computational fluid dynamic simulations of temperature, cryoconcentration, and stress time during large-scale freezing and thawing of monoclonal antibody solutions

Cryoconcentration and 3D Temperature Profiles During Freezing of mAb Solutions in Large-Scale PET Bottles and a Novel Scale-Down Device

Risk-based approach to setting sterile filtration microbial bioburden limits – Focus on biotech-derived products

An Intra-Company Analysis of Inherent Particles in Biologicals Shapes the Protein Particle Mitigation Strategy Across Development Stages

Silicone Migration From Baked-on Silicone Layers. Particle Characterization in Placebo and Protein Solutions

Replacing the Emulsion for Bake-on Siliconization of Containers-Comparison of Emulsion Stability and Container Performance in the Context of Protein Formulations

New FDA Draft Guidance on Immunogenicity

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