Stress factors in protein drug product manufacturing and their impact on product quality
TK Das, A Sreedhara, JD Colandene, DK Chou… - Journal of …, 2022 - Elsevier
Injectable protein-based medicinal products (drug products, or DPs) must be produced by
using sterile manufacturing processes to ensure product safety. In DP manufacturing the …
using sterile manufacturing processes to ensure product safety. In DP manufacturing the …
Rarefied porous flow in lyophilization: Review and open questions
This work presents the primary drying phase of pharmaceutical lyophilization (freeze drying)
as a rarefied gas flow through a porous medium. The goal is to stimulate interest in this …
as a rarefied gas flow through a porous medium. The goal is to stimulate interest in this …
[HTML][HTML] Intrahepatic cholestasis of pregnancy: In cooperation with the working group on obstetrics and prenatal medicine in the German Society for Gynecology and …
C Hagenbeck, U Pecks, F Lammert, MC Hütten… - Der Gynäkologe, 2021 - Springer
Intrahepatic cholestasis of pregnancy (ICP) is the most frequent pregnancy-specific liver
disease. It is characterized by pruritus and an accompanying elevation of serum bile acid …
disease. It is characterized by pruritus and an accompanying elevation of serum bile acid …
Primary Container Closure System Selection for Lyophilized Drug Products
R Ovadia, P Lam, H Roehl, R Janssen… - Principles and Practices …, 2023 - Springer
For lyophilization applications, the selection of the primary container system (ie vial, stopper,
seal) must be given careful consideration in order to avoid surprises in the later stages of …
seal) must be given careful consideration in order to avoid surprises in the later stages of …
Intrahepatic cholestasis of pregnancy
C Hagenbeck, U Pecks, F Lammert, MAC Hütten… - Der …, 2021 - europepmc.org
Die Schwangerschaftscholestase („intrahepatic cholestasis of pregnancy “, ICP) ist die
häufigste schwangerschaftsspezifische Lebererkrankung. Das Leitsymptom Juckreiz sowie …
häufigste schwangerschaftsspezifische Lebererkrankung. Das Leitsymptom Juckreiz sowie …