Karoline Bechtold-Peters
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View article: Biopharmaceutics of Subcutaneous Oligonucleotides. Part 1: The Effect of Drug Concentration, Injection Volume and Extracellular Matrix Composition on the Release of Oligonucleotides in Vitro
Biopharmaceutics of Subcutaneous Oligonucleotides. Part 1: The Effect of Drug Concentration, Injection Volume and Extracellular Matrix Composition on the Release of Oligonucleotides in Vitro Open
View article: The silicone depletion in combination products induced by biologics
The silicone depletion in combination products induced by biologics Open
Silicone oil (SO) migration into the drug product of combination products for biopharmaceuticals during storage is a common challenge. As the inner barrel surface is depleted of SO the extrusion forces can increase compromising the contain…
View article: The Silicone Depletion in Combination Products Induced by Biologics
The Silicone Depletion in Combination Products Induced by Biologics Open
View article: CMC Regulatory Considerations for Antibody-Drug Conjugates
CMC Regulatory Considerations for Antibody-Drug Conjugates Open
Antibody-drug conjugates unite the specificity and long circulation time of an antibody with the toxicity of a chemical cytostatic or otherwise active drug using appropriate chemical linkers to reduce systemic toxicity and increase therape…
View article: An Intra-Company Analysis of Inherent Particles in Biologicals Shapes the Protein Particle Mitigation Strategy Across Development Stages
An Intra-Company Analysis of Inherent Particles in Biologicals Shapes the Protein Particle Mitigation Strategy Across Development Stages Open
View article: Risk-Based Approach to Setting Sterile Filtration Microbial Bioburden Limits – Focus on Biotech-Derived Products
Risk-Based Approach to Setting Sterile Filtration Microbial Bioburden Limits – Focus on Biotech-Derived Products Open
View article: Compliance and Regulatory Considerations for the Implementation of the Multi-Attribute-Method by Mass Spectrometry in a Quality Control Laboratory
Compliance and Regulatory Considerations for the Implementation of the Multi-Attribute-Method by Mass Spectrometry in a Quality Control Laboratory Open
View article: Raman Marker Bands for Secondary Structure Changes of Frozen Therapeutic Monoclonal Antibody Formulations During Thawing
Raman Marker Bands for Secondary Structure Changes of Frozen Therapeutic Monoclonal Antibody Formulations During Thawing Open
View article: Impact of Autoclavation on Baked-On Siliconized Containers for Biologics
Impact of Autoclavation on Baked-On Siliconized Containers for Biologics Open
View article: The effect of mAb and excipient cryoconcentration on long-term frozen storage stability – part 2: Aggregate formation and oxidation
The effect of mAb and excipient cryoconcentration on long-term frozen storage stability – part 2: Aggregate formation and oxidation Open
View article: The effect of mAb and excipient cryoconcentration on long-term frozen storage stability – Part 1: Higher molecular weight species and subvisible particle formation
The effect of mAb and excipient cryoconcentration on long-term frozen storage stability – Part 1: Higher molecular weight species and subvisible particle formation Open
View article: Scaling Down Large-Scale Thawing of Monoclonal Antibody Solutions: 3D Temperature Profiles, Changes in Concentration, and Density Gradients
Scaling Down Large-Scale Thawing of Monoclonal Antibody Solutions: 3D Temperature Profiles, Changes in Concentration, and Density Gradients Open