相关参考文献
注意:仅列出部分参考文献,下载原文获取全部文献信息。Development of syringes and vials for delivery of biologics: current challenges and innovative solutions
Saki Yoneda et al.
EXPERT OPINION ON DRUG DELIVERY (2021)
Efficacy and safety of subcutaneous infliximab versus adalimumab, etanercept and intravenous infliximab in patients with rheumatoid arthritis: a systematic literature review and meta-analysis
Roberto Caporali et al.
EXPERT REVIEW OF CLINICAL IMMUNOLOGY (2021)
Product-Specific Impact of Viscosity Modulating Formulation Excipients During Ultra-High Concentration Biotherapeutics Drug Product Development
Danika Rodrigues et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2021)
Subcutaneous Delivery of High-Dose/Volume Biologics: Current Status and Prospect for Future Advancements
Advait Badkar et al.
DRUG DESIGN DEVELOPMENT AND THERAPY (2021)
Immunogenicity Challenges Associated with Subcutaneous Delivery of Therapeutic Proteins
Nicole L. Jarvi et al.
BIODRUGS (2021)
Comparison of Huggins Coefficients and Osmotic Second Virial Coefficients of Buffered Solutions of Monoclonal Antibodies
Jai A. Pathak et al.
POLYMERS (2021)
Key factors governing the reconstitution time of high concentration lyophilized protein formulations
Shreya S. Kulkarni et al.
EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS (2021)
Powder suspensions in non-aqueous vehicles for delivery of therapeutic proteins
Christoph Marschall et al.
EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS (2021)
A review of formulations of commercially available antibodies
Robert G. Strickley et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2021)
Preparation of high concentration protein powder suspensions by milling of lyophilizates
Christoph Marschall et al.
EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS (2021)
Caffeine as a Viscosity Reducer for Highly Concentrated Monoclonal Antibody Solutions
Yuhong Zeng et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2021)
Characterization of Excipient Effects on Reversible Self-Association, Backbone Flexibility, and Solution Properties of an IgG1 Monoclonal Antibody at High Concentrations: Part 1
Yue Hu et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2020)
Characterization of Excipient Effects on Reversible Self-Association, Backbone Flexibility, and Solution Properties of an IgG1 Monoclonal Antibody at High Concentrations: Part 2
Yue Hu et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2020)
What Makes Polysorbate Functional? Impact of Polysorbate 80 Grade and Quality on IgG Stability During Mechanical Stress
Adam Dariusz Grabarek et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2020)
Assessment of the Injection Performance of a Tapered Needle for Use in Prefilled Biopharmaceutical Products
Elena Krayukhina et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2020)
Accelerating the development of novel technologies and tools for the subcutaneous delivery of biotherapeutics
David S. Collins et al.
JOURNAL OF CONTROLLED RELEASE (2020)
Modeling and mitigation of high-concentration antibody viscosity through structure-based computer-aided protein design
James R. Apgar et al.
PLOS ONE (2020)
Physicochemical Rules for Identifying Monoclonal Antibodies with Drug-like Specificity
Yulei Zhang et al.
MOLECULAR PHARMACEUTICS (2020)
Strategies for high-concentration drug substance manufacturing to facilitate subcutaneous administration: A review
Melissa Holstein et al.
BIOTECHNOLOGY AND BIOENGINEERING (2020)
User experience for manual injection of 2 mL viscous solutions is enhanced by a new prefillable syringe with a stacked 8 mm ultra-thin wall needle
Aurelie Pager et al.
EXPERT OPINION ON DRUG DELIVERY (2020)
Reconstitution Time for Highly Concentrated Lyophilized Proteins: Role of Formulation and Protein
Shreya S. Kulkarni et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2020)
ENHANZE((R)) drug delivery technology: a novel approach to subcutaneous administration using recombinant human hyaluronidase 20
Kenneth W. Locke et al.
DRUG DELIVERY (2019)
Subcutaneous Injection of Drugs: Literature Review of Factors Influencing Pain Sensation at the Injection Site
Iris Usach et al.
ADVANCES IN THERAPY (2019)
Selecting and engineering monoclonal antibodies with drug-like specificity
Charles G. Starr et al.
CURRENT OPINION IN BIOTECHNOLOGY (2019)
Antibody Structure and Function: The Basis for Engineering Therapeutics
Mark L. Chiu et al.
ANTIBODIES (2019)
Intermolecular interactions in highly concentrated formulations of recombinant therapeutic proteins
Youngbin Baek et al.
CURRENT OPINION IN BIOTECHNOLOGY (2018)
Viscosity Control of Protein Solution by Small Solutes: A Review
Taehun Hong et al.
CURRENT PROTEIN & PEPTIDE SCIENCE (2018)
Novel salts of dipicolinic acid as viscosity modifiers for high concentration antibody solutions
Peng Ke et al.
INTERNATIONAL JOURNAL OF PHARMACEUTICS (2018)
Spectroscopic methods for assessing the molecular origins of macroscopic solution properties of highly concentrated liquid protein solutions
Jacob Blaffert et al.
ANALYTICAL BIOCHEMISTRY (2018)
Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities
Beate Bittner et al.
BIODRUGS (2018)
Polysorbate degradation in biotherapeutic formulations: Identification and discussion of current root causes
Mridula Dwivedi et al.
INTERNATIONAL JOURNAL OF PHARMACEUTICS (2018)
High-concentration protein formulations: How high is high?
Patrick Garidel et al.
EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS (2017)
Prediction and Reduction of the Aggregation of Monoclonal Antibodies
Rob van der Kant et al.
JOURNAL OF MOLECULAR BIOLOGY (2017)
Perspectives on Subcutaneous Route of Administration as an Immunogenicity Risk Factor for Therapeutic Proteins
Lora Hamuro et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2017)
A Formulation Development Approach to Identify and Select Stable Ultra-High-Concentration Monoclonal Antibody Formulations With Reduced Viscosities
Neal Whitaker et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2017)
In-silico prediction of concentration-dependent viscosity curves for monoclonal antibody solutions
Dheeraj S. Tomar et al.
MABS (2017)
Subcutaneous Injection Volume of Biopharmaceuticals-Pushing the Boundaries
Roman Mathaes et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2016)
Residual Host Cell Protein Promotes Polysorbate 20 Degradation in a Sulfatase Drug Product Leading to Free Fatty Acid Particles
Nitin Dixit et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2016)
Polysorbates 20 and 80 Degradation by Group XV Lysosomal Phospholipase A2 Isomer X1 in Monoclonal Antibody Formulations
Troii Hall et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2016)
Charge-mediated Fab-Fc interactions in an IgG1 antibody induce reversible self-association, cluster formation, and elevated viscosity
Jayant Arora et al.
MABS (2016)
Engineering the surface properties of a human monoclonal antibody prevents self-association and rapid clearance in vivo
Claire L. Dobson et al.
SCIENTIFIC REPORTS (2016)
Hydrogen exchange mass spectrometry reveals protein interfaces and distant dynamic coupling effects during the reversible self-association of an IgG1 monoclonal antibody
Jayant Arora et al.
MABS (2015)
Hizentra for the treatment of primary immunodeficiency
Richard L. Wasserman
EXPERT REVIEW OF CLINICAL IMMUNOLOGY (2014)
Ester Hydrolysis of Polysorbate 80 in mAb Drug Product: Evidence in Support of the Hypothesized Risk After the Observation of Visible Particulate in mAb Formulations
Steven R. LaBrenz
JOURNAL OF PHARMACEUTICAL SCIENCES (2014)
Concentrated Dispersions of Equilibrium Protein Nanoclusters That Reversibly Dissociate into Active Monomers
Keith P. Johnston et al.
ACS NANO (2012)
Investigating high-concentration monoclonal antibody powder suspension in nonaqueous suspension vehicles for subcutaneous injection
Mayumi Bowen et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2012)
Structure-based engineering of a monoclonal antibody for improved solubility
Sheng-Jiun Wu et al.
PROTEIN ENGINEERING DESIGN & SELECTION (2010)
Formulation and manufacturability of biologics
Steven J. Shire
CURRENT OPINION IN BIOTECHNOLOGY (2009)
Nature and consequences of protein-protein interactions in high protein concentration solutions
Atul Saluja et al.
INTERNATIONAL JOURNAL OF PHARMACEUTICS (2008)
High concentration formulations of recombinant human interleukin-1 receptor antagonist: II. Aggregation kinetics
John R. Alford et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2008)
Measuring and increasing protein solubility
Saul R. Trevino et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2008)
Commercial manufacturing scale formulation and analytical characterization of therapeutic recombinant antibodies
RJ Harris et al.
DRUG DEVELOPMENT RESEARCH (2004)
Challenges in the development of high protein concentration formulations
SJ Shire et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2004)
Stabilization of proteins in dry powder formulations using supercritical fluid technology
N Jovanovic et al.
PHARMACEUTICAL RESEARCH (2004)
Crystalline monoclonal antibodies for subcutaneous delivery
MX Yang et al.
PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA (2003)