Blueprint for antibody biologics developability
Large-molecule antibody biologics have revolutionized medicine owing to their superior
target specificity, pharmacokinetic and pharmacodynamic properties, safety and toxicity …
target specificity, pharmacokinetic and pharmacodynamic properties, safety and toxicity …
Aggregation of therapeutic monoclonal antibodies due to thermal and air/liquid interfacial agitation stress: Occurrence, stability assessment strategies, aggregation …
Therapeutic proteins, such as monoclonal antibodies (mAbs) are known to undergo stability
related issues during various stages of product life cycle resulting in the formation of …
related issues during various stages of product life cycle resulting in the formation of …
A comprehensive assessment of all-oleate polysorbate 80: free fatty acid particle formation, interfacial protection and oxidative degradation
N Doshi, J Giddings, L Luis, A Wu, K Ritchie… - Pharmaceutical …, 2021 - Springer
Purpose Enzymatic polysorbate (PS) degradation and resulting free fatty acid (FFA) particles
are detrimental to biopharmaceutical drug product (DP) stability. Different types and grades …
are detrimental to biopharmaceutical drug product (DP) stability. Different types and grades …
Adsorption and aggregation of monoclonal antibodies at silicone oil–water interfaces
Monoclonal antibody (mAb) therapies are rapidly growing for the treatment of various
diseases like cancer and autoimmune disorders. Many mAb drug products are sold as …
diseases like cancer and autoimmune disorders. Many mAb drug products are sold as …
Combined presence of ferrous ions and hydrogen peroxide in normal saline and in vitro models induces enhanced aggregation of therapeutic IgG due to hydroxyl …
S Sreenivasan, AS Rathore - Molecular Pharmaceutics, 2023 - ACS Publications
Therapeutic monoclonal antibodies (mAb) are known to form aggregates and fragments
upon exposure to hydrogen peroxide (H2O2) and ferrous ions (Fe2+). H2O2 and Fe2+ react …
upon exposure to hydrogen peroxide (H2O2) and ferrous ions (Fe2+). H2O2 and Fe2+ react …
Stress factors in primary packaging, transportation and handling of protein drug products and their impact on product quality
LO Narhi, DK Chou, TR Christian, S Gibson… - Journal of …, 2022 - Elsevier
Protein-based biologic drugs encounter a variety of stress factors during drug substance
(DS) and drug product (DP) manufacturing, and the subsequent steps that result in clinical …
(DS) and drug product (DP) manufacturing, and the subsequent steps that result in clinical …
End-to-end approach to surfactant selection, risk mitigation, and control strategies for protein-based therapeutics
AM Morales, A Sreedhara, J Buecheler, S Brosig… - The AAPS journal, 2022 - Springer
A survey performed by the AAPS Drug Product Handling community revealed a general,
mostly consensus, approach to the strategy for the selection of surfactant type and level for …
mostly consensus, approach to the strategy for the selection of surfactant type and level for …
Using Passive Microrheology to Measure the Evolution of the Rheological Properties of NIST mAb Formulations during Adsorption to the Air–Water Interface
ELN Escobar, MC Vaclaw, JT Lozenski, P Dhar - Langmuir, 2024 - ACS Publications
The development of novel protein-based therapeutics, such as monoclonal antibodies
(mAbs), is often limited due to challenges associated with maintaining the stability of these …
(mAbs), is often limited due to challenges associated with maintaining the stability of these …
Interfacial Pressure and Viscoelasticity of Antibodies and Their Correlation to Long-Term Stability in Formulation
KG Pham, BR Thompson, T Wang… - The Journal of …, 2023 - ACS Publications
Monoclonal antibodies (mAbs) form viscoelastic gel-like layers at the air–water interface due
to their amphiphilic nature, and this same protein characteristic can lead to undesired …
to their amphiphilic nature, and this same protein characteristic can lead to undesired …
Evaluating a modified high purity polysorbate 20 designed to reduce the risk of free fatty acid particle formation
N Doshi, K Ritchie, T Shobha, J Giddings… - Pharmaceutical …, 2021 - Springer
Purpose To evaluate a modified high purity polysorbate 20 (RO HP PS20)—with lower
levels of stearate, palmitate and myristate esters than the non-modified HP PS20—as a …
levels of stearate, palmitate and myristate esters than the non-modified HP PS20—as a …