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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.

July 2018
Effect of Proline on Viscosity of mAb Solns
Rational Design of Liquid Formulations
Nucleation and Stability of Lyo mAbs
Use of Polysorbates in Biopharmaceuticals
Oxidation of Polysorbates
Stability of SFD IgG in Sugar Matrices
Surfactants as Stabilizers of hGH
Buffers and Sugars in Lyophilized hGH
PS 20 and Proteins Adsorbed to Polystyrene
Comparability of mAbs
Microheterogeneity of mAbs
Aggregation of a Light-Exposed IgG1
Prediction of Met Oxidation in mAbs
Non-enzymatic Fragmentation of mAbs
Asn Deamidation in CDRs of mAbs
Unfolding and Aggregation of Interferon
Freezing and Quality of Lyophilized Protein
Stainless Steel on PS 80 Oxidation
Oligonucleotide Degradation Products
Stable Oligonucleotide Formulations

June 2018
Predicting Aggregation Rates in GCSF
Immunogenicity Assessment of Proteins
s.c. Administration of Proteins
Colloidal Stability at High Concentration
Shed Silicone Particles from Tubing
Grinding-Induced Subvisible Particles
Ascorbic Acid Inhibition of Fibrillation
Protein Coformulations
SIC as a Screening Tool for Aggregation
SVP Properties Associated with Toxicity
mAb Higher Order Structure Analysis
Formulation Effects on Silicone Oil
Mixing High Concentration Protein Solns
Photolytic Trp Fragmentation
Photoinduced Disulfide Scrambling
Effects of Excipients on Protein Solubility
Extensional Flow and IgG1 Aggregation
Freeze-Thaw Stability of a mAb
Protein Solubility from PEG Precipitation
Changes in Surface Properties of Proteins

May 2018
Surfactants and mAb Stability
Water Entrapment in hGH
Classification of Subvisible Particles
Monitoring Lyophilized Formulations
Monitoring Lyophile Collapse using DVS
Melibiose as a Stabilizer for Spray-Drying
HSA Nanoparticles for Ocular Delivery
Visible Light-Induced Damage of mAbs
Arg in Lyophilized Protein Formulations
HX-MS as Stability-Indicating Method
Cations and Reversibility of Unfolding
Stability of Proteins in Dilute Solution
Protein Nanoclusters as a Delivery System
Effect of Buffers on Lysozyme Stability
Glass State Relaxation during Annealing
pH and Interfacial Damage
Ice Nucleation Proteins and Lyophilization
Interactions of Sucralose with Lysozyme
Fast vs. Conservative Freeze Drying
New Look at Chemical Denaturation

April 2018
Freeze-Thaw Stability of TNF Inhibitors
TMAO Counteracts Benzyl Alcohol Effects
His and Polysorbate 20 Stability
Stability of T-DM1 and its Parent mAb
DSF Screening in Presence of Surfactants
Comparison of Instruments for CE-SDS
Fusion Protein at the Silicone-Oil Interface
Effect of Drying on mAb Conformation
Stainless Steel Effects on SVP Formation
Carbohydrates and Etanercept Stabilization
Formulation Robustness Evaluation
Photo-Induced Buffer Adducts
Aggregation at the Air-Liquid Interface
Pulse Resistive Sensing
Screening High Concentration Formulations
Stability Testing of Immobilized Antibody
New SEC Method for Analysis of ADCs
Crowders and Stability of Stem Bromelain
SEDDS Formulations of Bivalirudin
HIP and SEDDS of Peptide Drugs
HIP Complexes of Peptide Antibiotics

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

February 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 2018
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