Protein Instability at Interfaces During Drug Product Development
portes grátis
Protein Instability at Interfaces During Drug Product Development
Fundamental Understanding, Evaluation, and Mitigation
Krause, Mary E.; Li, Jinjiang; Tu, Raymond
Springer Nature Switzerland AG
02/2022
338
Mole
Inglês
9783030571795
15 a 20 dias
534
Descrição não disponível.
1. Overview of the impact of protein interfacial instability on the development of biologic products .- 2. Protein adsorption at a gas-aqueous interface.- 3. Interfacial behaviors of proteins.- 4. Interfacial stresses during drug substance purification processes.- 5. Evaluation of interfacial stress during drug product development.- 6.Relating interfacial shear and dilatations stress-es to protein aggregation in mAbs.- 7. Analytical techniques for evaluating protein instability at interfaces.- 8. Analysis of aggregates and particles.- 9. Protein interfacial instability of mixing and lyophilization during drug product manufacturing process scale-up and tech transfer.- 10. Excipients: Characterization, purpose, and selection.- 11. Interfacial stress and proteins prepared in the solid state.- 12. Interfaces in protein drug delivery: device concern.- 13. Future perspectives.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
Protein purification;drug delivery of biologics;drug storage condiditons;protein interfacial stress;protein container compatability
1. Overview of the impact of protein interfacial instability on the development of biologic products .- 2. Protein adsorption at a gas-aqueous interface.- 3. Interfacial behaviors of proteins.- 4. Interfacial stresses during drug substance purification processes.- 5. Evaluation of interfacial stress during drug product development.- 6.Relating interfacial shear and dilatations stress-es to protein aggregation in mAbs.- 7. Analytical techniques for evaluating protein instability at interfaces.- 8. Analysis of aggregates and particles.- 9. Protein interfacial instability of mixing and lyophilization during drug product manufacturing process scale-up and tech transfer.- 10. Excipients: Characterization, purpose, and selection.- 11. Interfacial stress and proteins prepared in the solid state.- 12. Interfaces in protein drug delivery: device concern.- 13. Future perspectives.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
