Recommended best practices for lyophilization validation—2021 part I: process design and modeling
F Jameel, A Alexeenko, A Bhambhani, G Sacha… - AAPS …, 2021 - Springer
Abstract This work describes lyophilization process validation and consists of two parts. Part
I focuses on the process design and is described in the current paper, while part II is devoted …
I focuses on the process design and is described in the current paper, while part II is devoted …
LyoPRONTO: an open-source lyophilization process optimization tool
G Shivkumar, PS Kazarin, AD Strongrich… - AAPS …, 2019 - Springer
This work presents a new user-friendly lyophilization simulation and process optimization
tool, freely available under the name LyoPRONTO. This tool comprises freezing and primary …
tool, freely available under the name LyoPRONTO. This tool comprises freezing and primary …
Lyophilization scale-up to industrial manufacturing: A modeling framework including probabilistic success prediction
Scaling-up a lyophilization cycle to the manufacturing scale successfully at the first pass is of
crucial importance to the bio-pharmaceutical community in order to save expensive and …
crucial importance to the bio-pharmaceutical community in order to save expensive and …
Recommended best practices in freeze dryer equipment performance qualification: 2022
A Ganguly, L Hardwick, S Tchessalov, SL Nail… - AAPS …, 2023 - Springer
Best practices for performing freeze dryer equipment qualification are recommended,
focusing on identifying methods to quantify shelf thermal uniformity (also known as “shelf …
focusing on identifying methods to quantify shelf thermal uniformity (also known as “shelf …
Mathematical model of freeze drying taking into account uneven heat and mass transfer over the volume of the working chamber
E Mokhova, M Gordienko, N Menshutina - Drying Technology, 2022 - Taylor & Francis
The calculation of the kinetics of freeze drying in Python for materials of various structures
was implemented. The features of mathematical modeling of the kinetics of freeze drying for …
was implemented. The features of mathematical modeling of the kinetics of freeze drying for …
Chapter 21: Rational Design of a Freeze-Drying Process for Protein Products
Freeze-drying is a commonly used manufacturing operation for biopharmaceuticals to
enhance the storage stability. The stability of the product during freeze-drying and upon …
enhance the storage stability. The stability of the product during freeze-drying and upon …
A compact model for lyophilizer equipment capability estimation
This work presents a compact model for the equipment capability limit of a common
configuration of pharmaceutical lyophilizers, a product chamber separated from the …
configuration of pharmaceutical lyophilizers, a product chamber separated from the …
Principles and Practice of Lyophilization Process and Product Development: Scale-Up and Technology Transfer
A Bhambhani, J Stanbro, A Sethuraman… - Principles and Practices of …, 2023 - Springer
Best practices for lyophilization cycle and product development, in both the development
and manufacturing settings, are described here. Scale-up challenges associated with …
and manufacturing settings, are described here. Scale-up challenges associated with …
LyoPRONTO: Deterministic and Probabilistic Modeling–Tutorial and Case Study
P Kazarin, A Alexeenko - Principles and Practices of Lyophilization in …, 2023 - Springer
The current work extends the application of the Lyophilization and Process Optimization
Tool (LyoPRONTO) from the deterministic (Shivkumar et al. AAPS PharmSciTech 2019; 20 …
Tool (LyoPRONTO) from the deterministic (Shivkumar et al. AAPS PharmSciTech 2019; 20 …
Overview of Heat and Mass Transfer Modeling in Lyophilization to Create Design Spaces and Improve Process Analytical Technology (PAT) Capability
Lyophilization or freeze-drying is a process of removing water by sublimation. It is commonly
used to extend the shelf life of drugs in the pharmaceutical industries. Due to a relatively …
used to extend the shelf life of drugs in the pharmaceutical industries. Due to a relatively …