Issue Summary
Below are the topics covered in the most recent issues of Staying Current: Formulation of Biopharmaceuticals. Please visit Staying Current and select an option, if you'd like to subscribe.
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Tolerability of s.c. Injections
Risk Assessment for Combination Products
Predicting mAb Bioavailability
Stabilization of mAbs during Protein A
Peptide Solubilization
Aggregation of Liraglutide
Studies on Glucagon Aggregation
Protein Inclusion into Ice
Bubbles and Freeze-Induced Aggregation
Predicting Long-Term Storage Stability
Combined Shear and Interfacial Stress
Interface-Induced Protein Particle Formation
NaCl and Agitation-Induced Aggregation
Preformulation Study of a Bispecific
Effect of Sucrose and NaCl on mAb PPIs
Predicting mAb Deamidation Propensities
Freezing Drug Substance in Bottles
Directional F/T of Protein DS in Bottles
Database of Antibody Developability
Developability of Certain Small Proteins
Stability of Various Surfactants
Osmolyte-Induced Protein Stability
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Stability of a Bispecific Duet Antibody
Prediction of mAb Storage Stability
Protecting Proteins during Drying Stress
Silicone Depletion in Biologics in PFS
Developability Assessment of an IgG3
Post-Manufacturing Handling of Biologics
Aggregation/Charge Heterogeneity of mAbs
Basic Variants of Trastuzumab
IEX Binding of mAb Charge Variants
CE-MS Characterization of Charge Variants
Spectroscopic Analysis of Aggregates
mAbs in Tablet Form
Interfacial and Shear Stress on mAbs
Luminescent Probe for Amyloid Formation
Charge Heterogeneity Mass Spectrometry
Stress of Transport of Immunoglobulins
Shear and Interfacial Stress of mAbs
SEC of Diverse Biopharmaceuticals
Application of QbD to SEC for mAbs
Stability of Fractionated mAb Variants
ThT as Reporter of Microviscosity
In-Use Stability of IVIG and Rituximab
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Co-Solvents in Protein Formulations
Betaine Stabilization of Lactoperoxidase
Combined Effects of HP-β-CD and PS 80
Proteins in ILs and DES
Osmolyte Stabilization of RNase
Stabilization of Lysozyme in DES
Aggregation Inhibition by Arginine
Modulation of LLPS by Osmolytes
Understanding Glucagon Aggregation
Arg Inhibition of PolyQ Oligomerization
Light Effects on Low pH Unfolding of mAb
Use ArgHCl During Enzyme Spray-Drying
Effect of Co-Solutes on Barnase
Protein-Protein Cross-Interactions
Effect of Amino Acids on PPIs
Triazolium ILs and BSA Stability
Cellulases at the Air-Water Interface
Adsorption at the Water-Oil Interface
MD Simulations of Lyophilized Proteins
Review of Fluorescence-Based Methods
Fluorescence Correlation Spectroscopy
Intrinsic Fluorescence of mAbs
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Stability of Protein Pharmaceuticals
Predicting Stability of Lyophilized HSA
Raman Analysis of Stressed Proteins
Manufacturing Changes for mAbs
Histidine as an Excipient for Proteins
Innovation in ADC Development
Osmolytes and PEG Effects on an Enzyme
Screening Kit for LLPS Behavior
Factors Affecting the Stability of RNA
Advances in AI for Drug Development
Effect of Aggregates on Immunogenicity
Safety of Visible Particles in Parenterals
Injectability Modeling for Prefilled Syringes
Optimizing Excipient Properties
Modeling Bi-Specifics in Aqueous Solution
Effects of mAb Charge Heterogeneity
DeepSP: Predicting mAb Stability
Fc Mutations to Reduce mAb Viscosity
Effect of PS 80 Grade on Biologics
Conversion from Vial to Injection Device
Mutations to Improve the Viscosity of mAbs
Stabilization of Lyophilized Enzymes
HES as a Cryoprotective Agent
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Effect of Surfactants on mAb Analysis
Oxidation of Polysorbates
Formulation and Manufacturing of AAV
Poloxamer 188 and AAV6 Stability
Approved Oligonucleotide Products
Approved Parenteral Peptide Formulations
Phe as a Stabilizer of alpha-Amylase
Proteins in Ionic Liquids (ILs)
ILs as Drug Delivery Systems
PS 20 Degradation in Protein Formulations
Stable Peptide Nanoparticle Formulations
HC Lyophilized Protein Formulations
Effect of Stirring on Particle Formation
Protein Stability in s.c. Environment
Retinal Delivery of mAbs via Eye Drops
Polysulfobetaines as Aggregation Inhibitors
Evaluation of NTA Parameters
Products in the FDA Purple Book
Dual Function Surfactants as Excipients
Poloxamer 188 in Lyophilized Formulations
Effect of Surfactants in LDH in Solution
Particle Tracking Microrheology of mAbs
Passive Microrheology of NIST mAb
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Oxidation Propensity Screening of mAbs
Adsorption of mAbs to Air-Water Interface
Ion Binding to mAbs Using MD Simulation
Stabilization of Lysozyme by Sugars
Stability of HC Spray-Dried mAbs
Mobility of Lyophilized HSA using ssNMR
Microwave Freeze Drying of IgY
Anion-Induced Aggregation of Insulin
Raman Spectroscopic Study of Insulin
Antibody Association and Cluster Formation4
Computational Methods and Aggregation
Overview of Peptide Aggregation
Anomalous Diffusion of mAbs
Machine Learning and mAb Development
Glycation of Proteins
Systemic Sublingual Delivery of Proteins
Long-Acting Antibody Drugs
Thermal Treatment of Biosimilars
mAb Aggregation at Interface under Flow
Effect of Osmolytes on Tau Aggregation
mAb Charge Variants and Aggregation
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Solid-State Stability of a mAb
Reducing Reconstitution Times
Shape Effects on Viscosity of Proteins
Immunogenicity of Protein Particles
Surface Activity and Interfacial Aggregation
Cryopreservation of Mammalian Cells
Loss of CCI in a PFS at Low Temperatures
Photostability of Nivolumab
Review of Macromolecular Crowding
Effect of Sorbitol and Betaine on Lysozyme
Visible Bubbles in Lyophilized Proteins
Iron Binding and Photofragmentation
Reduction of Viscosity by Proline Analogs
Aggregation Inhibition by Arg
Effect of Tubing on PS 80 Oxidation
Glycosylation Effects on Colloidal Stability
Factors Governing Viscosity of mAbs
Safety of Subvisible Silicone Oil Droplets
Diafiltration-Induced Damage of a mAb
Agitation-Induced Aggregation of ADCs
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Agitation-Induced Aggregation of Proteins
Self-Association of Fc-Fusion Proteins
Coarse-Grained Simulations of mAbs
Relaxation in Freeze-Dried Formulations
Shaking of Freeze-Dried Formulations
Ion Binding and mAb Aggregation
Poly(Glu) Derivatives as Viscosity Reducers
Osmolality of High Concentrations mAbs
Taurine as a Stabilizer of mAbs
Nano-Osmolytes as Stabilizers
Use of ILs and DES as Stabilizers
Monitoring Visible Particles in Parenterals
wNMR Characterization of HC mAbs
pH Effects on HCP Polysorbate Degradation
Heat Inactivation to Slow Polysorbate Loss
Aggregation Kinetics of PTH(1-84)
Fractionation of Protein Particulates
Potency and Stability of Charge Variants
Flow-Induced Aggregation Assay for mAbs
Salt Effects on Protein LLPS
Forced Degradation Studies: Comparability
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Injectable Hydrogel Particles for mAbs
Depot s.c. Injections of Antisense Products
Fill-Finish Operation for Biologics
Prediction of mAb Viscosity Behavior
Barriers to Inhalation Therapy Using mAbs
Dry Powder Inhalation of siRNA
Hydration and Protein Stability in DES
Effects of DES on Enzymes
Phospholipids to Inhibit Protein Aggregation
Aggregation Slowed by Osmolytes
Developing Novel Aflibercept Formulations
PS20 Degradation Affects mAb Formulation
Osmolyte-Induced Protein Stabilization
Polyelectrolyte Stabilization of LDH
Asn Deamidation at Asn-Trp Site in a ADC
Modeling Deamidation in Solution
Approaches for s.c. Delivery of Proteins
Effects of Vibration from Drone Transport
Shear Stress on Protein Pharmaceuticals
Stabilization of Proteins by Saccharides
Development and Manufacture of Biologics
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Interface-Mediated Protein Aggregation
Cyclodextrins in Drug Delivery
Complexation with Sulfated Cyclodextrins
Preservatives and Interactions with mAbs
Aggregation Pathways for Antibodies
Protein Stabilization by Sugars
Arg and Arg Ester as Possible Stabilizers
Stabilization Strategies for Protein Drugs
Reversible Protein Complexation
Coacervation of Protein Complexes
Predicting Biotransformation
PTMs and Stable Dried Protein Powders
Predictions of mAb Developability
Review of mAb Developability
Lyophilization of AAV8
Microwave-Assisted Freeze-Drying
Developable Antibody-Based Products
Surfactants in mAb Cell Culture Medium
Delivery of Polypeptides to the Eye
Deep Learning in Antibody Development
Nanofiltration of mAbs
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Advances in Lyo Cycle Development
mAb PPIs and Viscosity Behavior
NMR Analysis of Thermally Stressed mAbs
Aggregation during Peristaltic Pumping
Use of QbD in Lyo Development
Simulations of mAb Self-Association
Arginine in Protein Formulations
Effects of Charged Amino Acids
Subvisible Particle Image Analysis
Oxidation of Polysorbates
kD Values and Predicting Viscosity
Interfacial Pressure and Long-Term Stability
Deamidation/Clipping in LC of a mAb
PEG Precipitation and Colloidal Stability
Devitrification of Lyoprotectants
Occurrence of Ser-Lys Crosslink in a mAb
Optimization of Flow Imaging Microscopy
mAb In-Use Stability with Degraded PS 20
mAb Aggregation in Cell Culture
α Relaxation of Long-Term mAb Stability
Annealing and Shrinkage of Dried Sugars
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Predicting Aggregation Using ILs Alternatives to Polysorbates
Preclinical Studies: Caffeine as an Excipient
Protein Stabilization during Manufacturing
Review of Insulin Aggregation
Instabilities during Manufacturing
Prediction of pH-Dependent Solubility
Sugars Inhibit Insulin Aggregation
Biological Diversity of Trehalose
Trehalose Effects in Synuclein Fibrillation
Sugars as Cryoprotectants
Stabilization of Irisin by Trehalose
Review of Noncovalent PEGylation
Disaccharide Stabilization of hGH
Injectable Devices for Protein Delivery
Protein Stabilization by Disaccharides
Trehalose as a Lyoprotectant for Phages
Protein Solubility Optimization
Viscosity Predictions from MD Simulations
pH/salt Effects on Self-Association of mAbs
Interfacial Particle Formation with mAbs
Delivery of Biologics to the Colon
Effects of Crowding by PEG