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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.

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

July 2019
Stabilization of ‘Non-Platform’ mAb
Oxidative Stress Testing of Biologics
Stability of Trastuzumab Emtansine
Formulation of ADCs
Prediction of Deamidation Rates of HX-MS
Surface Active Agents in Use in the Eye
Oral Delivery of Polypeptides
HOS and Trp Oxidation in mAbs
Excluded Solutes and mAb Aggregation
Oxidation and Aggregation in Lactoglobulin
Polysorbate Degradation
Precipitation of a mAb at s.c. Injection Site
Local Concentrating of Protein in a Syringe
Surfactants and Interfacial Protein Behavior
Evaluation of Freeze-Drying Excipients
Primary Drying using Micro Freeze-Dryer
Peroxide Uptake by a mAb: Storage Study
Microscopic Imaging of Fractal Aggregates
IgG Charge Profiles
Maximizing EPO Solubility
Peptide Optimization
Liraglutide Oligomerization

June 2019
Heterogeneity of IgG Antibodies
Stability of Vaccines: A Review
Leaching of Metals from Stainless Steel
Effect of Deamidation on Structure/Stability
Chemoselective Oxidation
Cross-Linking at Asp and Asn Residues
Modeling Deamidation of Gln Residues
Slow Ramp Rate and Product Collapse
Dextrans as Lyoprotectants for LDH
Oxidation of ADCs
Mannitol Hemihydrate and mAb Stability
Monitoring Insulin Stability by CGE
Spray-Dried Viral Vector Formulations
Quantifying Succinimide Levels
Deamidation and Colloidal Stability of mAb
PPIs and Viscosity of HC mAb Solutions
Spray Freeze Drying and Drug Delivery
Developing Biologics Tablets
Solution Stability of Poloxamer 188
Measuring Silicone Oil with 1H NMR
Stability in Polymeric Delivery Systems
Interfacial Stress of Biologics

May 2019
EDTA as a Stabilizer of mAb and PS 80
Photostability Under LED Lights
Stability and Formulation of ADCs
Designing Lyophilized Formulations
Optimized IgG Formulations
Vial Fogging in Lyophilized Products
Cycle Optimization with MicroFD
Glycerol-Free Cryostorage of Proteins
Large-Scale Freezing of Proteins
Single-Step Freeze-Drying
Comparison of qLD to Other SVP Methods
Predicting Long-Term Storage Stability
Holographic Analysis of Subvisible Particles
Biophysical Properties and Storage Stability
FTIR Microscopy of Subvisible Particles
Needle Tip Drying during HC mAb Filling
Thermostable Adjuvanted Ebola Vaccine
Freezing Step in Lyophilization
Freezing and Stability of Dried Products
Spray-Freeze Drying of IgG
NMR to Monitor Reconstitution
Photolytic Labeling in Lyophilized Solids
Crowding Effects on Stem Bromelain
Quantitation of Polysorbate 80

April 2019
Novel Surfactant for Protein Formulations
ArgHCl in Lyophilized Formulations
HSP70 and Immunogenicity of mAbs
Ramp Rates during Primary Drying
Split (Lyo) Cakes
Effect of Extractables on Theromostability
Ice Fog Methods and Freeze-Drying
Buffer Effects on BsAb Colloidal Stability
Microstructural Changes in Protein Powders
Test Models for Protein Immunogenicity
AFM to Study Protein Aggregation
Quantitation of Protein Particles
Deamidation and Isomerization in mAbs
Stabilization of Spray-Dried Fab
Liquid Formulations of tPA
Developability Protocol for mAbs
Pulse Proteolysis as a Screening Tool
Arg/Glu Stabilization of Rice Proteins
Surfactants and Surface-Inducted Unfolding
Modeling Colloidal Stability of mAbs
Failure of Vials during Lyophilization

March 2018
D-Amino Acid Formation in a mAb
Glycation of Milk Proteins
Interactions of Biologicals with Packaging
Chemical Instability in EtO-Sterilized PFS
Use of FFFS to Monitor Protein Changes (2)
Removal of Particles in FVIII Product
Chemical Unfolding Assay for Screening
Thermally Induced Gelation of Ovalbumin
Enhancers for Intranasal Delivery of Insulin
Ionic Strength and Lysozyme Fibrillation
Freeze-Thaw of an IgG1
Phase Separation of Lysozyme during F/T
PPIs and Predicting Solution Viscosity
NMR to Monitor Crystallin Aggregation
Polyvalent Ions and Phase Separation
Reduced Volume Effects on LO
LO/Flow Imaging Comparison for SVPs
Dissolution of Spray-Dried Powders
Ion Specificity of Hydration by NMR
mAb Glycation by Dextrose
Stabilization of Proteins by MOFs

February 2019
Dimers of an IgG2 mAb
IFN-α2a Oxidation and HOS
Effect of PEGs on Enzyme Activity
SDS-PAGE for mAb Domain Unfolding
Trp Oxidation in the CDRs of mAbs
Thermal Shift Assay and Protein Stability
Surfactant Stabilization of a Fusion Protein
Solubilization of Glucagon Analog
Protein Precipitation during Purification
Reproducibility of Aggregation Kinetics
Amino Acids as Bulking Agents
Nanobubbles and Peptide Self-Assembly
Controlled Ice Nucleation Methods
Control of Dimerization of mAbs
Protein Glycation in Freeze-Dried Solids
Novel Degradation of a Fusion Protein
Lyophilization and Infrared Thermography
Imaging Lyophilized Cake Appearance
Developability Assessment of mAb Variants
pH Jump and F/T Stability
Dilution from a Denaturant Approach
Aggregation at Silicone Oil-Water Interface
Commentary on Protein Aggregation
Self-Inhibition of Insulin Fibrillation

January 2018
Glycan Shedding
Removal of Aggregation Precursors
Improved Precision of HOS using CD
Oxidation Effects on a mAb
Injection Site Reactions and Polysorbate
Leachables from Lyophilized Products
Use of In-Line Filters for Biologics
Viscosity Modifiers for HC mAbs
Stability at Low pH for a mAb
PPIs in HC Protein Formulations
Stabilizers of Erythropoietin
Dilution Approach to mAb Stability
Deamidation-Resistant Mutants of mAbs
Intranasal Delivery of Biologics
HOS and Conformational Changes
Antibody Drug Delivery
Protein Characterization by IEX-MALLS
Determination of PS 80 in Protein Samples
Rapid Protein Concentration Determination
Free Thiol Quantitation in mAbs
SV-AUC Technique for HC Proteins
Methods for Measuring Charge Variants
Cross-Interaction Chromatography
Flow Cytometry and LS Detection