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.

  • 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

  • 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

  • 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

  • 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

  • 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

  • Alternative Surfactants for Biologics

    Biosurfactants in Pharmaceutical Products

    Cyclodextrins as Drug Stabilizers

    Modeling Viscosity Behavior of mAbs

    Poloxamers in Nanomedicine

    Polymeric in situ Forming Depots

    Long-Acting Microneedle Formulations

    Intermolecular Interactions in an ADC

    Deamidation of Pertuzumab

    Formulation of AAVs

    Oxidation of Polysorbates

    Arg/HP β CD Deep Eutectic Solvents

    Formulation of Non-Invasive Vaccines

    Trisulfides in Multi-Specific mAbs

    Monitoring Aggregation using CE-SDS

    Silicone Oil-Induced Aggregation

    Controlling Glycation with Cyclodextrins

    Protein Amyloid Aggregates

    Particulate Impurities in AAVs

    Protein Stabilization by Aptamers

    Controlling Deamidation of Capsid Protein

    Formulation of Oncolytic Viruses

  • Stabilization of Proteins by Sugars

    Deamidation Promoting Aggregation

    Chemical Chaperones as Stabilizers

    Chemical Chaperones as Stabilizers

    Particle Formation in mAb Infusions

    In-Use/Compatibility Studies for Biologics

    Stability Predictions of Biopharmaceuticals

    Solid-State Lysozyme-Sucrose Interactions

    Lyo Cycle Design for HC Proteins

    Lyo Protein-Specific Excipient Effects

    Solid mAb Formulation in an Auto-Injector

    Reformulation of a mAb

    Determinants of Viscosity in HC mAbs

    Amyloid Aggregation and LLPS

    De-/Stabilization of BSA by Sugars

    Polysorbate Degradation Kinetics

    Poloxamer 188 and F/T Damage

    Effect of Freezing Citrate Solutions

    Container Effects on PS 80 Oxidation

    Oxidative Fragmentation of an IgG1 mAb

    Raman Analysis of Acidic HC Formulations

    In-Use Studies on Pertuzumab

  • Review of HC mAb Formulations

    Review of Nucleic Acid Therapeutics

    Commercial Antibody Formulations

    Approved Oligonucleotide Therapeutics

    Polypeptide Instability in Polymer Systems

    Acidic Variants of mAbs Induced by MCO

    Succinimide Formation in CDR of a mAb

    mAb Aggregation Mechanisms

    Alternative Surfactant and Bioprocessing

    Factors Affecting Silicone Oil Migration

    Reversible Self-Association of mAbs

    Additive Effects on Antibody Stability

    Sugar Effects on Protein Fibrillation

    Surface Activity and Interfacial Stability

    Behavior of a mAb at Air-Water Interface

    Tribofilm Behavior of BSA with Metal Ions

    Characterizing Protein Lyo Formulations

    Microstructure of Lyophiles

    Oxidation-Induced Aggregation of a mAb

    Microwave-Assisted Freeze-Dryin

    Downstream Processing of mAbs

    IL-Based Processing and Formulation

  • PPIs and Viscosity Behavior of mAbs

    Developability of HC mAb Formulations

    Properties of Marketed mAb-Based Products

    Cake Appearance of Lyophilized Proteins

    Inhibition of Fibrillation by 18-crown-6

    Chemical and Physical Stability of Peptides

    Self-Association and Viscosity of mAbs

    Protein Photooxidation under Visible Light

    Spray Freeze Drying (2)

    Predicting the Shelf-Life of Lyophiles

    Crystallization in Lyo Protein Samples

    Water Dynamics and Protein Stability

    mAb Stability in Prefilled Syringes

    Deep Eutectic Solvents for IgGs

    mAb-Excipient Interactions by NMR

    Machine Learning and Viscosity Behavior

    Preservatives in Polypeptide Formulations

    Aggregation of Calcitonin Variants

    Competitive Adsorption of mAb/PS 80

    Chemometrics in Protein Formulation

  • Stability of mAbs in Ambient Light

    Sensitivity and Variability of MFI

    Inherent Particles in Biologicals

    Particle Formation by Flow Cytometry

    Stabilized HC mAb Formulation

    Review of TFF Operations

    Multi-Instrument MFI Evaluation

    Terminal Sterilization of Biologicals

    Pulse Radiolysis and Oxidative Crosslinking

    Unfolding and Aggregation of LCs

    Predicting Protein Solubility

    Optimization of Protein Solubility

    Developability Studies of mAbs (2)

    Concentration-Dependent Fab Stability

    Effects of Excipients on Viscosity

    MCO and Acidic Charge Variants in a mAb

    Polysorbates and IgG1 Particle Formation

    Relationship between PPIs and LLPS

    B22 Values and LLPS

    Surface-Mediated Aggregation

    Thermal Aggregation of hGH

    Developability Risks for mAbs

  • Protective Effects of Sugars on Dry Proteins

    Stability of Freeze-Dried IgY

    Morphology of Sucrose/Mannitol Mixtures

    Nebulization In-Use Studies

    SC Depot Behavior of Peptide Conjugate

    Atomization Effects on Spray Freeze-Drying

    Mannitol-Based Antibody Lyo Formulations

    ssNMR Analysis of Lyo mAb Formulations

    Stabilization of mRNA Products

    Polysaccharides to Stabilize Peptides

    Immunogenicity of Stressed Adalimumab

    Stability of an Acidic mAb

    SVPs by Holographic Video Microscopy

    Forced Degradation Studies of Peptides

    Formulation Strategies for Peptides

    Immunogenicity of Protein Aggregates

    Developability Assessment of mAbs

    Chemical Chaperone Effects on Aggregation

    Excipient Effects on Stability of BSA

    Improving the Properties of Peptide Drugs

    Long-Term Stability of Infliximabs

    Excipients of BMP-2 Refolding

  • Studying Protein Aggregation

    Surface-Induced Aggregation

    Modeling PPIs and Viscosity Behavior

    In-Vial Detection of Protein Unfolding

    Sustained s.c. Release of scFv

    Oxidation of PS 80 in Stainless Steel

    Analytical Workflow and Developability

    Developability Assessment of mAbs

    Is There a Superior Fraction of PS 20?

    Peristaltic Tubing Effects on TFF Operation

    Deep Eutectic Solvents to Stabilize IgGs

    Measuring Self-Association of mAbs

    Predicting mAb Stability Profiles

    Predicting mAb Behavior during TFF

    Dynamics in Predicting mAb Properties

    Polymeric Excipient and Colloidal Stability

    Measuring the Stability of ADCs

    Conformational Changes and LLPS

    Predicting mAb Viscosity Behavior

    Visible Particle Formation and Silicone Oil

    Stabilization by PEGs of Different Sizes

    PLGA Depots for Leuprolide Acetate