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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.

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

April 2017
Surfactants and MAb Stabilization
Hydrogen Bonding in Trehalose Matrices
MCO and Protein Carbonylation
Polyols and Bromelain Stabilization
Second Virial Coefficients and Solubility
Freeze-Thaw Stability of a MAb
Scan Rate Dependence of DSC
UF of HC MAb Formulations
Intrinsic Viscosity at Low Ionic Strengths
Crowding Agent and Protease Denaturation
Insulin Oligomers by NMR and ESI-MS
Sucrose and Insulin Fibrillation
UF of an Fc-Fusion Protein
Semiautomated Sample Preparation
Interference with NTA Measurements
Reproducibility of SEC
Solvation Shell by IR-MCR Spectroscopy
Aggregation of Glycated BSA
Glycation of γB-Crystallin
Glycation of Aβ Peptide
Glycation of Albumin

March 2017
Multivalent Anions and MAb LLPS
Dynamic Heterogeneity of Water
Cooperative Hydration of Proteins
pH and Injection Site Pain
Fibrillation of Pramlintide
Calculation of Hofmeister Effects
EPO Stabilization by Amino Acids
Salts and Lysozyme Stability and Activity
Particulates in IV Products
Proteins in Sugar Glasses
Consistent Heat Transfer in Lyophilization
Osmolyte Stabilization of Sheep Albumin
Rapid Peptide Mapping of a MAb
Sodium Ions and Peptide Solubility
Seeded Fibrillation of Antibody LCs
PLA Micro- and Nano-particles
Crowding and β2-microglobulin Fibrillation
Excipient Interactions in Frozen State
Unfrozen Water in Frozen State
Tg’ of Maximally Freeze Concentrated State

February 2017
Photo-oxidation of an IgG1 MAb
Immunogenicity of Biopharmaceuticals
CD to Monitor Collagen Fibrillation
Difference UV Spectra of BSA Unfolding
Anti-PEG Antibodies in Patients
PECs for Protein Oral Delivery
pH-Buffer Effects on MAb Stability
TMO: Anti-aggregation Agent
Charge Microheterogeneity of MAbs
Excipient in Biopharmaceutical Products
Protein-Disaccharide Interactions
Hydration and Stabilization by Osmolytes
Water-Protein Hydrogen Bond Networks
Disaccharides and Water Dynamics
SAXS to Examine Viscosity of MAbs
Self-Association and Viscoelasticity
Reduction of Viscosity by Arg Salts
Fab-Fc Interactions, RSA, and Viscosity
Cationic Amino Acids and Viscosity
Excipient Effects on Stability and Viscosity

January 2016
Silicone Oil Migration into Protein Products
Aggregation of p53
Aggregation Quantitation using AUC-SV
Water Rearrangement in Fibril Formation
QSAR Excipient Screening
Solution X-Ray Scattering of MAbs
Insulin Amyloid at the Injection Site
Stabilization of β-D-Galactosidase
Challenges in Determining PPIs from DLS
Measuring Unfolding at an Interface
Protein Stabilization by Amino Acids
Osmolyte Stabilization of Proteins
Decision Making Based on HOS data
Osmolyte Effects on Fibril Growth
Phase Separation: Proteins and Amino Acids
Oxidation of Residues in CDRs
Met Oxidation of Aβ 1-40)
Copper-Catalyzed MCO of Aβ
Oxidation of Etanercept
RP-UPLC Method for Measuring Oxidation
Correction