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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Ensuring Vaccine Cold-Chain Integrity
Glycerol as a Stabilizer of Endoxylase
Marketed mAb Formulations
Freeze-Thaw-Induced Aggregation of mAbs
Stabilization of rAAV2 during Purification
Glycerol Reduces Chemical Degradation
Photodegradation of a Fab Fragment
Review of HC mAb Formulations
Buffer and pH Effects on an IgG4 mAb
Temperature Effects on Aggregation
Effects of Controlled Ice Nucleation
Stability of Lyophilized Polypeptides
Mannitol Crystallization in Spray-Dried GH
Stabilizers for Proteins in Solution
mAb Stability at the Air-Water Interface
Downstream Processing Stresses on AAVs
Designing Protein-Stabilizing DES
Colloidal Stability of mAbs
Optimization of Formulation Development
Solution Behavior of Poloxamer 188
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Hydrophobicity assay for Developability
RP-HPLC Assay for Co-Formulated mAbs
Hydrogel for Sustained Release of mAbs
Effect of Tungsten Impurities from PFS
Ubiquitin Stabilization by Proline
Formulation and Oral Delivery of GLP-1
Antibody-Oligonucleotide Conjugates
Ultrahigh Concentration mAb Formulations
Visual Inspection of Parenterals
Shear-Induced Aggregation of Insulin
Small Peptides as Excipients for Proteins
F/T Stress and Protein Aggregation
Measuring Apparent Protein Solubility
Optimizing Multispecific Antibodies
Use of Met in HC mAb Formulations
Risk of SVP Formation in mAb Formulation
Cryoconcentration of Biologic BDS
Developability Assessment of mAbs
Atypical Dynamics of HMW Species
Annealing and Lyophilization
Choline Chloride as a Protective Osmolyte
Bubble Formation in Lyo Formulations
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Dynamic Clusters in mAb Formulations
Effect of Preservatives on mAb Stability
Sugars and Stability of Lyophilized Proteins
Stability of Nonglycosylated mAbs
Prediction of Viscosity Behavior of mAbs
Placebos for s.c. mAb Drug Products
Perspective on High-Dose Biologics
P188 and PEG/PPG-Based Formulations
Electrostatics and Viscosity of Antibodies
Chemical Stability of Liraglutide
Buffer-Free Protein Formulations
Preformulation Study on Semaglutide
Formulation Development for Biosimilars
Solid RNA-Lipid Nanoparticle Formulations
ATP Stabilization of HSA
Photostability of ADCs
mAb Stability in Sustained Release Products
mAb Mutation Effects on Colloidal Stability
Viscosity Reduction using Ionic Liquids
Review of Viscosity-Reducing Excipients
Predicting pH Shifts during Dialysis
Degradation Profiles of Biosimilars
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Development of RNA-Based Therapeutics
ISRs with Subcutaneous IgG Infusion
Spin-Freeze-Drying of a PEGylated Peptide
Delivery Systems for DNA and RNA
Higher Order Structure of Oligonucleotides
Overview of Deamidation
Buffer Effects on Cyclodextrin Complexes
Effects of Mutations on Protein Stability
High Dose/High Concentration Products
Particle Analysis by BMI
mAbs and Surfactants at Air-Water Interface
Preservatives and Tubing
mAb Formulation Development: Editorial
Solubility Assessment using PEG Pptn
Alternatives to Polysorbates
Aggregation of a Amylin Agonist Conjugate
Specific Binding of Mg Ions to a Protease
Development of Placebos for Biologics
Impact of pH Change upon Use of Dry Ice
mAb Aggregation by Mass Spectrometry
Stabilization of Aerosolized mRNA-LNPs
pH-Shift-Induced Aggregation of IgGs
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Precipitation and mAb Solid Dosage Forms
Trehalose/HP-b-CD for Spray Dried mAbs
Rescue of AAV Filter Losses by Surfactants
Solid mAb Dosage Forms by Precipitation
Surfactants and Dripping of mAb Solutions
mAb Gelation under Low pH Conditions
Relaxation in Lyophilized Formulations
Alternative Surfactants for Biologics
Interfacial Stress and Aggregation of BSA
Overview of Aggregation of Protein Drugs
Survey of Aggregation Analytical Methods
Effect of Initial Aggregate Level for mAbs
Modulation of mAb Colloidal Stability
Water Mobility in Lyophilized HSA
Use of Arg during Ultrafiltration
Particle Formation during Pumping
mAb Aggregation during Administration
Manufacturing Challenges for Lyophiles
mAb Adsorption at the Air-Water Interface
ILs as Potential New Vaccine Adjuvants
Osmolyte-Induced Stabilization Mechanism
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Protein Stability in Frozen Solutions
Lyoprotection of Taq DNA Polymerase
Dry Powder Bacteriophage Formulation
Protein-Peptide Coformulation
Parenteral Peptide Product Development
Polysorbate Analysis with HPLC-CAD
Effect of Surfactants on Protein Structure
Cyclodextrins and Lysozyme Stability
mRNA Stabilization and Formulation
Formulation of Oncolytic Viruses
Chelating Agents and mAb Oxidation
Subvisible Particle Formation
Freezing-Induced Denaturation of MP
Vibrational Damage to Lyophilized Protein
Subcutaneous Delivery of HC mAbs
Inhibition of Urea-Induced Aggregation
Evaluation of Novel Surfactants
Clouding Behavior of Polysorbate 80
High-Throughput Screening for Oxidation
Silicone Oil and Dupliximab Stability
Perspective on Predictive Stability
Analytical Control Strategy for Biologics (2)
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LLPS of HC mAb Formulations
Arg, Hydration and Protein Stability (2)
Glucagon Oxidation and Aggregation
PS 20/80 and Peptide-Protein Formulations
Subvisible Particle Risks in mAbs
Vaccine Formulation Design
Preformulation Study on hMANF
Arg Effects on Cytochrome c
Betaine as a Stabilizer for Aβ (25-35)
Pore Structure Variance in Lyo Cakes
Thermal Interactions between Lyo Vials
Modulation of Insulin Aggregation
Developability Framework for mAbs
in vitro Serum Stability Assay for mAbs
Filling HC Biopharmaceutical Formulations
Interactions of Sugars with Lysozyme
Polyphosphate and Aggregation Suppression
Photostability of үD-Crystallin
Vial Quality and Frozen Drug Products
SVP Profile for Ophthalmic Proteins
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Prediction of Viscosity of mAb Solutions
Excipients in Ophthalmic Products
Liposomes and s.c. Delivery of mAbs
Single-Step Lyophilization of Proteins
Freezing-Induced Damage of a Bispecific
Prediction of mAb Viscosity Behavior
Protein Adsorption during Manufacturing
Protein Stabilization and Spray Drying (2)
Excipients and Phenol-Induced Precipitation
Studying mAb Aggregation
Intervention in Insulin Fibrillation
Stability of Advanced Biologic Therapeutics
Formulation Development of ADCs
Ionic Liquids as Protein Stabilizers
Agitation-Induced Aggregation Propensity
Vial Fogging in Lyophilized Products
Predicting Long-Term Stability of mAbs
Water and Deamidation of Dried Proteins
Combination of Cyclodextrin/Carrageenan
Cyclodextrin and Lysozyme Denaturation
Particle Formation during Pumping
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Self-Association of mAbs by QCM-D
Monitoring AAV Stability Using HIC
Sterile Filtration and Particle Formation
Ultra-High Concentration Formulations
Ectoines as Possible Stabilizers of GH
Bubbles during Reconstitution of Etanercept
Polysaccharide Effects on Dried Proteins
Polysorbate-Degrading Enzymes
Lipidation Effects on GLP-1
Mannitol Crystallization in the Frozen State
Enhanced Stabilization of Dried Probiotics
DLS as a QC Tool for Labeled Antibodies
Search for Viscosity-Reducing Excipients
Formulation of a CMV Vaccine
Fattigation Technologies for Medicinals
Syringe Handling during IgG Dilution
Oxidative Stress Testing of Trastuzumab
Osmolyte Screening as Stabilizers
Silanol Density and mAb Stability
Stability of IV Preparations of an ADC
LLPS and Stability of IgY
Excipient-mAb Interactions
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Stabilization of Biologics in the Solid State
In Vivo Deamidation of mAbs
Glycine as a Stabilizer of a Luciferase
Protein Stabilization by Zwitterions
Formulation Effects on Trastuzumab
Stabilization by Trehalose Nanoparticles
Fragmentation of an IgG1 mAb
Lyophilized Formulations of AAV5
Lyophilized Formulations of mRNA-LNPs
Trehalose Stabilization of IgG1s
Stabilization of Senecavirus Antigen
Protein-Polyelectrolyte Complexes of IgGs
L-Tyrosine as a Stabilizer
Competitive Adsorption of PS 80 and mAb
Impact of Citrate on PS 80 Degradation
His Accelerates Fe-Catalyzed Oxidation
HSA Slows Amyloid Formation
Effect of Excipients on Colloidal Stability
Trisulfide Bond Formation in Proteins
Aggregation of Antibodies
Amphiphilic Excipients to Stabilize Proteins
Insulin Degradation in the Solid-State
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Development of Lyo Protein Products
PAT Methods for Co-Formulated mAbs
Aggregation in Frozen State Upon Dropping
HTS and HC Protein Formulations
HTS and HC Trastuzumab Formulation
Buffers and HC Lyo Formulations
Amyloid Aggregation Databases
CEX and mAb Co-Formulations
MD and Protein-Excipient Interactions
Quantitation of Surfactants using qNMR
Stabilizers for Erythopoietin (EPO)
Stabilization of Infliximab by HP-β-CD
Destabilization by Polyamines
Removal of Surfactants from mAb Solutions
2-MIDHP as a Stabilizer of mAbs
Role of Arg with Peptides and Proteins
Effect of UVC Irradiation on Lysozyme
Fe (III)/Citrate Effects on Photostability
Photodegradation of Fe(III)-Lactate
Fluorochemical Carriers for Biologics
Injectability of HC Suspensions
Hexametaphosphate as a Stabilizer
Advances in Polypeptide PEGylation
Modification Strategies for Peptides/Proteins
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Effect of Cyclodextrins on ADC Stability
Sucrose vs. Trehalose as Stabilizers
Protein-Buffer Interactions by NMR
Factors Influencing Polysorbate Stability
Oleic Acid and mAb Particle Formation
Stabilization by HP-β-CD with Electrolytes
Fibrillation Inhibition by ATP
Buffer Effects on Ultrafiltration of BSA
Overview of Protein Glycation
Review of Oxidation of Food Proteins
Developability Consideration for Bispecifics
Predicting Viscosity of HC mAb Solutions
Machine Learning and LNP Development
Solid-State Behavior of Lyophilized IgG2
Impact of Sugar-to-mAb Ratio on Stability
Buffer Effects on Lyo Protonation State
Protein-Polysorbate Interactions
Insulin Aggregation
Thermal and pH Stress Effects on mAbs
Supercooling and Vaccine Stability
Condensates and Protein Aggregation
Arg Suppresses TTR Aggregation