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.

  • 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

  • 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

  • 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

  • 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

  • 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