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.

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • Biologics for Pulmonary Delivery

    NMR Study of Frozen Pembrolizumab

    Light-Coupled NMR to Study Stability

    Development of Peptide-Based Therapeutics

    Analysis/Delivery of Short Peptides

    Protein-Buffer Interactions by NMR

    Alternative Buffer Systems for mAbs

    Buffer Effects on Stability of an IgG4

    Mg2+ and Heterogeneity of Trastuzumab

    Crowding and Protein Aggregation

    NMR Monitoring of mAb Stability

    Local and Systemic Drug Delivery of mAbs

    Stabilization of mAbs by Arg and Glu

    Polymer-Mediated Stabilization

    Guluronic Acid Disaccharide as an Additive 6 Albumin as a Surface-Active Excipient

    Cryoprotectant Potential of a Zwitterion

    Root Cause of Analysis of Visible Particles

    Container Effects on SVP Formation

    DSC to Study Peptides during Freezing

    Electrochemical Biosensors for Amyloid

    Microfluidic Sensor for mAb Aggregates

    Biosensing Strategies for Aggregates

    Summary of Aggregate Detection Methods

  • Initial HMW and mAb Aggregation Kinetics

    Large-Volume Subcutaneous Delivery

    s.c. Delivery of mAbs in Oncology

    Thermal Aggregation of Proteases

    Functions of Arg in Biochemistry

    Reversible Complexes and s.c. Delivery

    Arg Stabilization of Luciferase Enzyme

    Stabilization by Lyso-Phosphatidylchloline

    Stabilization by ATP at Low Temperatures

    Betaine Impacts Lactoperoxidase Stability

    Inhibition of Fibrillation by Sugars

    Impact of Buffers in PS 80 Oxidation

    Degradation of PS 20

    Factors Affecting Vial Fogging

    Degradation on Insulin in the Solid-State

    Evaluation of Various Lyoprotectants

    Transition from i.v. to s.c. Administration

    Lyophilization of Parenteral Products

    Deaeration/PS 80: Thin-Film Freeze-Drying

    mAb Aggregation at Silicone Oil Interface

    Aggregation Behavior of mAbs

    Crowding and LLPS of Aβ Peptide

  • 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

  • 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

  • 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

  • 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