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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.

September 2020
Interfacial Adsorption of mAbs
Viscosity of HC mAb Formulations
Bispecific Antibody Formulations
Interaction Volume and Aggregation Rates
Asp Isomerization of Peptides
Oxidation of Polysorbates
Development of HC Protein Drug Products
LLPS and Protein Aggregation
Protein Stability during Nebulization
Study of Freezing of Biologics using CFD
mAb Aggregation during TFF
QbD Approach to TFF Robustness
Freeze-Concentration of Solutes
Stability of Hepatitis E Vaccine
Stability of Dried HPV Vaccine
Proteins at the Ice-Water Interface
Maximally Freeze-Concentrated State
Hydrolysis of Polysorbate 20
Quantifying Covalent Aggregation
Stabilization by Charged Amino Acids
Proteins at the Air-Water Interface

August 2020
Reducing Reconstitution Times
Photoinduced His-His Crosslinks
Photoinduced Fragmentation of IgG4-Fc
Radical Induced Hinge Degradation of IgG1
Protein Modifications by Ionizing Radiation
Heterogeneity in Dried Protein Products
Controlled Nucleation for Lyophilized hGH
Lyophilized Hb-BSA Clusters
Nucleation Temperature & Residence Times
Protection of BSA by SDS
Inhibition of Aggregation by Organic Acids
Inhibition of Insulin Aggregation by Arg
Amino Acids and BSA Denaturation
Fibrillation of a GLP-1-like Peptide
Water Distribution of Lyophilized IgG1
Through-Vial Impedance Spectroscopy
pH Effects on Crystallization and Stability
Dried Phage Therapy Formulations
Predicting Long-Term Storage Stability
Freeze-Thaw-Induced Damage of Proteins
Thiol-Type Antioxidants
Radical Scavenging by Amino Acids

July 2020
Subvisible and Submicron Particulates
CTAB and Tungsten-Induced Aggregation
Tungsten-Induced Aggregation
Spray-Dried Nanocomplexes of DNA
Glucagon Fibrillation
Soluble Aβ Oligomers
Mass Spec of Aβ Aggregates
Effect of Low pH and on a MAb
Protein-Silicone Oil Interactions
Tween 20 in a Protein-Silicone Oil System
Hydroxybutyrate Prevents Aggregation
Surface Charge and Protein Solubility
Stability of Abatacept
Comparability of Protein IR Spectra
VCD of a Molten Globule State
Deamidation of IL-15
Viscosity and Aggregation Rates
Lyophilizate Collapse and Stability
Mannitol Crystallization and LDH Stability
Freeze Agglomeration of Alum Adjuvants
Aggregation of a LC Dimer
Ligand Binding, Fluorescence Quenching

June 2020
Spectroscopic Quantitation of Misfolds
SEC-MS Analysis of mAbs
Stability of Cetuximab Drug Product
Formulation Development of Biologics
Aggregate Fingerprinting using BLI
Effects of Crowding on Antibody Function
Impact of Bevacizumab on Catheters
Particle Formation of mAb during Pumping
Standards for Visible Protein Particles
Mg2+ Binding and Stabilization of BSA
Particle Shedding from Tubing
Development of a Liquid IgG1 Formulation
Thermal Stability of HC β-Lactoglobulin
Advancing Protein Discovery/Development
Development of New 20% SCIG Product
Analytical Artifacts in mAb Development
Macromolecular Confinement in Lyophiles
PAT of UF/DF Operation
Low Volume Cloud Point Determination
Monitoring ADC Aggregation using Raman
Electroviscous Effect on Viscosity
mAb Aggregation in Bulk and on Surfaces
Stability of Rotavirus Vaccine (2)

May 2020
Photo-Degradation of Proteins
Chemical Degradation after s.c. Injection
Factors Affecting Viscosity of HC mAbs
Modeling pGlu Formation
Drop Shock Cavitation
Proteolysis and Cross-Linking Processes
Extended Delivery of Polypeptides
Compounding Biologics in SOF Syringes
Degradation of α-Conotoxin
Container Surfaces and Mechanical Shock
RSA of HC mAb Formulations (2)
PPIs and Clusters in HC mAb Formulations
Physicochemical Stability of mAbs
New Stabilizers of mAbs
Dipeptide Stabilizer of Interferon-α2a
Neutralization and Low pH Aggregation
SVP Formation from Powder Grinding
Interferometric Scattering Microscopy
Backgrounded Membrane Imaging
Automated Identification of Particle Images
Imaging Flow Cytometry
SVPs in Cell Therapy Products
Comparison of NTA and RMM
NTA and Particle Morphology

April 2020
Asp Isomerization in CDRs of mAbs
Single Step Freeze-Drying
Brij-58 as a Protein Stabilizer
Nanobubbles in Recon Lyo Products
Accelerated Storage Stability of mAbs
Metal Surface-Induced Aggregation
Buffer Effects on Lys Glycation
Robustness of Primary Drying
Freezing Effects during Freeze-Drying
Design Space for Primary Drying
Flow and Interfaces on mAb Aggregation
Surfaces and mAb Thermal Aggregation
Predicting IgG Colloidal Stability
Selecting a Container Closure System
Protein Stability at Subzero Temperatures
Stabilization by Charged Amino Acids
Modeling Aggregation of mAbs
Predicting Long-Term mAb Stability
Standardization of Reconstitution
AAV Formulation Development
AF4 Analysis of Virus-like Particles
Quantitation of AAVs
DSF to Distinguish AAV Serotypes
Development of AAV Products for the Eye
Paradigms for Pharm. Biotechnology

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