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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.

March 2020
Review of Pain upon s.c. Injection
Freezing of Biologicals
PPIs in a Mixture of Two mAbs
DLS and Prediction of Viscosity Behavior
RP-UPLC-MALLS for mAb Analysis
EPR to Study mAb Interactions
Predicting mAb Self- and Cross-Interactions
Machine Learning of mAb Interactions
Dextrans in Lyophilized mAb Formulations
Excipients for Freeze-Dried mAbs
Leachable Effects on IVIG Aggregation
Molecular Basis of High Viscosity
Label-Free Analysis of Aggregation
Excipients for Aggressive Freeze-Drying
Lyo Stabilization of Polyclonal Antibodies
Flow Imaging Methodology
Complement Activation by Particles
SVP Quantitation in Intravitreal Products
SVPs in PFS after Mechanical Shock
Silicone Oil Particles and Immunogenicity
Shape Characterization of SVPs
Methods for Particle Characterization
Isomerization in Polysorbate 80
PS 80 Degradation of mAb Aggregation
Stabilization of IgG by PS 80
High Throughput HPLC Analysis of PS 80
High Throughput Assay for Polysorbates
Monitoring Polysorbate Hydrolysis
Screening PS 80 Composition

February 2020
Selection of Diluents for IV mAbs
Chemical Degradation via Thiyl Radicals
Antibody Design, Manufacture, Formulation
Co-Formulation of EPO and G-CSF
Enhanced Protein Stability by Preheating
Role of Aw in Protein Stability
Electrospray Differential Mobility Analysis
Microwave-Assisted Freeze-Drying
Determination of Water Content using NMR
HSA-Stabilized Lyo Formulations of IgG
Excipient Effects on Colloidal Stability
Disaccharides and PPIs
Sucrose vs. Trehalose in Lyo Formulations
Polysaccharides as Drug Delivery Vehicles
Chemical Instability Effects on Aggregation
Flow and Heating Effects on Whey Protein
Additive Effect on Protein Fibrillation
Oxidation of Proteins in Food Products
Particle Formation during Shipping
Packaging Effects on Mechanical Shock
Use of Osmolytes in Vaccine Production
Survey of Forced Degradation Studies
Macrocycles and BSA Aggregation

January 2020
Liquid vs. Lyo Formulation of Prolastin-C
pH/Buffer Profiles during DF of mAbs
Viscosity and Colloidal Stability of mAbs
PEG Stabilization of Levansucrase
Oligosaccharides as Stabilizers
Liquid Parenteral Protein Formulations
Review of Preservatives
Fibril Formation in β2-Microglobulin
Improved Separation of Protein by HPLC
mAb Aggregation during Low pH Hold
Glutamine Deamidation
Deamidation and Met Oxidation of IFN-α
Oxidation of Myofibrillar Proteins
Temperature Scanning Viscometer
Polyphosphates and Protein Solubility
Polymers and Aβ(1-40) Fibrillation
Stabilization by Amphiphilic Polymers
Dry Powder Pulmonary Delivery of mRNA
Trp Oxidation in Amino Acid Solutions
Volatile Counterion in Lyophilized Peptides

December 2019
Stabilization by Charged Amino Acids
Macromolecular Crowding and Hydration
Viscosity Reduction with Hydantoin
Approval of Novel Excipients
Self-Diffusion of Highly Concentrated mAb
Science and Art of Protein Formulation
Succinimide Formation and Fibrillation
Color Formation and Protein Quality
Predicting B22 Values from Calculations
CHO Markers: Predictors of mAb Stability
pGlu Formation in mAbs
Lyophilized BSA Formulations
Viscosity Reduction using Cavitation
Deamidation and γS-Crystallin Aggregation
Low pH Peptide Mapping for Succinimide
Protein Structure from UV Absorbance
mAb Fouling of Virus Removal Filters
Sorbitol Stabilization of an Immunotoxin
Polyanions and Reentrant Condensation
Autofluorescence and Protein Oxidation
Structural Losses and Activity Decreases

November 2019
Platform for Monitoring mAb Aggregation
Raman to Monitor ADC Aggregation
Aggregation-Induced Emission
THz Dielectric Spectroscopy of Proteins
Osmolytes and Asparaginase Stability
Forced Degradation of Compounded mAbs
Asp Isomerization and Aggregation
Hydrophobic Amino Acids in Dried Powder
Modeling Degradation Kinetics in Dry Food
Freeze-Dried Pore Size Distributions
Ionic Compounds and Solid-State Stability
Mobility in Spray-Dried BSA Formulations
Stereospecific Interactions of His and mAb
Novel Stabilizer for Interferon-α
Orthogonal Stability Testing of Adalimumab6
Dynamic Bioconjugation to Lower Viscosity7
Stability of HC0020 β-Lactoglobulin Solutions
mAb Self-Association and HIC Behavior
Assessing PS 20 Degradation
Quantifying PS 80 Levels by NMR
Thermal Shift Assays

October 2019
Liquid to Lyophilized Formulation Change
Mannitol Hemihydrate and mAb Stability
Impact of Freezing on Product Morphology
Effect of Drying Method and Excipients
Parenteral Delivery of Peptides and Proteins
mAb Formulations for Nebulization
Amino Acids as Stabilizers
Amino Acid Polymers as Stabilizers
Redesign of Proteins to Improve Solubility
SEC Method for Cetuximab
NMR Monitoring of HOS
CE-SDS Analysis of mAbs
Sustained Release for Intraocular Delivery
Redesigning Food Protein Formulations
Lyophilized Sugar-Polyol Formulations
Bioprocessing and mAb Dimer Formation
Measuring Protein Self-Association by SEC
Polyphosphate-Induced Fibrillation
Particles in Repackaged Bevacizumab
Co-Formulation of Insulin and Amylin

September 2019
Salts and Protein Adsorption to COP
Colloidal Approach to mAb Self-Assembly
Loss of Benzyl Alcohol in PFS
Predicting Mutational Effects on Solubility
Predicting Aggregation Prone Regions
Subvisible Particles in Parenteral Products
Control Strategies for Particulate Matter
H2O2 Diffusion into Liquid Products
Variance in LO and Flow Imaging
Workflow for Characterization of mAbs
Quantitation of Free Suflhydryls
Neural Networks in mAb Development
Biosimilarity Assessment of Infliximab
Excipient Effects on Viscosity of a mAb
Simulations of PPIs in HC mAb Solutions
Modification Can Lower PPIs and Solubility
Controlling Protein Aggregation
ReFOLD Assay for Protein Formulation
Amyloid Formation in Food Proteins (2)
Aggregation Rate and β-Sheet Content

August 2019
Macrocycle Stabilization of a mAb
Sequence Effects on LLPS and a mAb
Oligosaccharide Stabilization of an Enzyme
High-Throughput mAb Solubility Screening
HX-MS to Identify Aggregation Regions
Charge Variants in Co-Formulated mAbs
Topical Delivery of Antibody in a Hydrogel
Immunogenicity of Proteins
Silicone Oil and mAb Immunogenicity
Immunogenicity of a Bispecific Antibody
Cluster Formation and Viscosity
HX-MS of High Concentration mAbs
Aggregate Quantitation
Glycation Promotes hIAPP Fibrillation
Lysine Inhibits Glycation and Aggregation
Interfacial Aggregation of mAbs
In vivo Modifications of mAbs
SDS Stabilization of Lysozyme
CE for Characterization of mAbs and ADCs
High pH Mobile Phases for RP-HPLC
MS-Compatible Mobile Phases for IEX
Evaluating Protein-Surfactant Interactions