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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.

December 2017
Aggregation and Viscosity of BSA
Needle Clogging and Filling MAb into PFS
N-Ac-Trp as a Sacrificial Additive
Mannitol Hemihydrate
Protein Stabilization in Silk Fibroin
Neutron Scattering Methods
Lysozyme-Trehalose-Glycerol Systems
Prediction of Deamidation
Protein Particulates from Oil Droplets
Isothermal Calorimetry and Denaturation
Protein Stabilization by Betaine
MAb Stabilization by Peptide Dendrons
Screening IFN-γ Formulations using DSF
Stabilization of Glutathione Transferase
Use of DSC in Process Development
Characterization of MAb Products (2)
Topical Delivery of a Neutralizing Antibody
Protein Release from Microcapsules
Protein Release from Hydrogels
Release of Proteins from Electrospun Fibers


November 2017
Manufacturability Indices for MAbs
Mass Spec Analysis of Deamidation
Multimeric Antibody Formulations
Stabilization of β-LG by Polyols/Sugars
Arg and Thermal Aggregation of IgGs
Fibrillation of Human Calcitonin
HP-β-CD Stabilization of Spray-Dried IgG
Polysorbates and Anaphylaxis
High Concentration Insulin Formulations
Thermal Gradient IR of Lyophilizates
Bioavailability of Proteins by SC Injection
QSAR of Protein-Protein Interactions
Osmolytes Protect Against Irradiation
Novel Stabilizer for Peptide Drugs
Thermo-Optical Methods for Preformulation
Handling of Proteins in a Hospital
Precipitation of Lysozyme by Buffer Salts
In Silico Solubility Screening of MAbs
Stability-Solubility Tradeoff


October 2017
Protein Adsorption to IV In-Line Filters
Formulations of Marketed MAb Products
Reducing Viscosity of Concentrated MAbs
Rheo-NMR Studies of Proteins
QSAR of Polyol Stabilization of a MAb
Concentrated Endostatin Formulations
Analysis of Flow Imaging Data
Immunogenicity of Aggregates in Syringes
Protein-Polyelectrolyte Complexes
Immunogenicity Risk of SC vs. IV Dosing
Stable Vaccine Microneedle Preparations
Polymers and Oral Insulin Delivery
Particle Sizing using Flow Cytometry
Acidity of Lyophilized Phosphate Buffers
Trehalose/HP-β-CD Lyo Formulations
Pullulan/Trehalose Lyo Formulations
Moisture Content Determination by NIR
Glycerol-Trehalose Lyo Formulations
Ramp Rate and Lyo Cake Properties
Lyophilization of Dual Chamber Cartridges

September 2017
HTS of MAb Formulations
Screening of MAb Formulations
Trp Fluorescence and Tertiary Structure
Comparison of SV-AUC and SEC
Protein Distribution in the Frozen State
Arg and Other Stabilizers for Human IgG
Ectoines and IFN-α2b Stability
Charge Variants in an IgG MAb
Deamidation and Fibrillation of IAPP
Degradation and Analysis of Polysorbates
Freeze-Thaw Stability of BDS
His Oxidation Crosslinking
Particle Size Analysis of PLGA Products
Excipient Effects on LLPS of an IgG1
Extensional Flow-Induced Aggregation
Arg-Glu Effects on MAb LLPS
Gelation Inhibition by CSA Salts
Ultrafiltration of MAbs
Co-Purification of MAbs and Cathepsin D.
Host Cell Protein, LPL, and PS Degradation

August 2017
Thermal Stabilization by Sugars
Automated Fluorescence Microscopy
PS 80 and Particles in Pre-filled Syringes
Degradation of Polysorbate 20
Polysorbate Quantitation
Silicone Oil and Lysozyme Immunogenicity
Arg Stabilization of Egg White Proteins
DLS as an Orthogonal Method for SEC
Covalently Attached Molecular Rotors
DSC and DSF of Proteins
DSF Evaluation of IFN-γ Formulations
Stabilization of Ovotransferrin by Polyols
Light-Induced His Crosslinking
Deamidation Effects on Fibrillation
Quality of Synthetic Peptides
Hinge Region Hydrolysis of MAbs
Fragmentation of MAbs
Analysis of MAbs by HILIC
2-D HPLC to Monitor MAb Aggregation
HPLC Methods for MAbs (2)

July 2017
Cake Appearance of Lyophilized Products
Comparison of Lyophilized Antivenoms
Freeze-Drying Emulsion Adjuvant Vaccines
Vial Size Effects on Fibrillation Kinetics
Preservatives and MAb Stability
Inhibition of Protein Aggregation
Ascorbate Inhibition of Insulin Aggregation
Protein-Excipient Interactions
Effect of Oxidation on Interferon HOS
Stabilization by Octanoate and N-Ac-Met
Additives that Reduce MAb Viscosity
Asn Deamidation in a MAb
Bioluminescent Assay for Deamidation
Analysis of MAb Fragments
Fibrillation of pE-Aβ (3-42)
Rapid Fibrillation of a Lipase
Method for Monitoring Tyr Oxidation
NMR to Detect Protein Aggregates
Vial Geometry and Freeze-Drying
Proteins as Enzyme Lyoprotectants

June 2017
Shipping-Induced Aggregation of MAbs
Cavitation and Agitation Effects
Sterilization Effects on EPO Stability in PFS
EtO Sterilization and MAb Stability
Aggregation from Shear Stress
Trehalose Phenylalaninate as a Stabilizer
Small Amines as Protein Stabilizers
Improved SEC Method for MAbs
Particle Formation in a Bioconjugate
Particle Formation of a MAb in PFS
Immunogenicity of a IgG Antibody
Aggregation Propensity and HX-MS
Stability of Deglycosylated Fc Fragment
Prediction of Aggregation Propensity
Effect of PFS and Filling Lines on Stability
Osmolytes and BSA Aggregation
Flow Imaging and PLGA Microparticles
Cross-Seeding of IAPPs
Deamidation of TNF-α
Prediction of Deamidation/Isomerization
Asp Glycosylation and Isomerization

May 2017
MAb SVPs and Immune Tolerance
Hydrogen Bonding in Amorphous Glasses
Stabilization of Proteins in the Solid State
Hydrogen Mobility in Dried Proteins
Role of Buffers in Protein Formulations
SVPs and Immunogenicity
Fluorescent Sensor for Monitoring Aβ
Surfactant Effects on Protein Photostability
Novel Nonionic Surfactants
Mutational Effects on scFv Stability
QSAR of Amino Acid Excipients
Quantitation of MAb Aggregates
Aggregation and High Protein Conc
Buffers and Delamination of Glass Vials
Hofmeister Effects at Air-Water Interface
Silicone Oil and Crystallin Aggregation
PASylation of Interferon-β1b
Immunogenicity of Interferon-β1b
PTMs and LC Stability
Thermal MAb Fragmentation
MAb Fragmentation in CDR3