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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 2018
Forced Degradation Studies of mAbs
MCO of mAbs and Aggregation
Oxidation Susceptibility of mAbs
QCM Studies of mAbs
High Concentration mAb Solutions
Cyclodextrin as Excipients
i.v. Administration of a Protein
Cys Oxidation Induces Fibrillation
Chemically Modified Aβ
Protein Stability in Prefilled Syringes
Particulates from Glass Vials
Surface Properties of Various Glass Vials
Controlled Ice Nucleation and LDH
Arg/Sugar Lyo Formulations
Solid-State Denaturation of Whey Protein
Isomalt as a Lyoprotectant
ssHDX-MS Analysis of a Lyophilized IgG1
His and Myosin Aggregation
Developability of Biopharmaceuticals
Colloidal Stability of Bivalent Antibodies

Febuary 2018
Nanoparticulate Impurities in Sucrose
UF and Protein-Protein Interactions
Beads and Amyloid Fibrillation
Multi-Attribute Method: mAb Degradation
Cysteine as Anti-Aggregation Agent
Immunogenicity of Particles in Syringes
Sucrose and Stabilization of an Oxidase
Photodegradation of hGH
Preferential Interactions with IgG1 mAbs
Stability of Infliximab
Kinetic Conformational Stability of IgGs
Metal Ions and Hemoglobin Aggregation
Additives and Co-Aggregation of Proteins
Protein Aggregation
Friability Testing of Stability
Analysis of mAb Charge Variants
Deamidation in the Solid State
HDX of Lyophilized mAb Formulations
DNA-Based Arrays to Detect mAb Changes
Preservatives (3)

January 20178
SVP Analysis by Flow Cytometry
Prediction of Met Oxidation Sites
Effect of Sugars on hGH during Freezing
High Concentration mAb Formulations
Direct Analysis of Excipients using HILIC
Quantitation of Oxidation in mAbs
Improving the Properties of mAbs
Dye Monitoring of Aggregation
Trehalose and BSA Structure
Met Oxidation and FcγRIIa Binding
Selecting Low Viscosity mAb Formulations
Charge Variants and mAb Behavior
Fc Glycosylation and mAb Performance
Effect of PS20/PS80 on mAb HOS
Phase Behavior of an Fc-Fusion Protein
Peptide Aggregation
Peptide Analysis using HILIC-MS
Accelerated Stability Comparability Studies
Charge Shielding and GFP Aggregation
Macromolecular Crowding and Aggregation

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 2018
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)