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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.

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

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

Mayl 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 2019
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