The authors provide their perspectives on shipping validation.
The author addresses critical issues to consider prior to performing forced degradation studies and provides best practice recommendations for these types of studies.
Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media.
Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media.
Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media.
Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media.
The authors discuss the use of single-use bioreactors.
A modular cell-culture platform demonstrates accelerated process development.
A modular cell-culture platform demonstrates accelerated process development.
A modular cell-culture platform demonstrates accelerated process development.
A modular cell-culture platform demonstrates accelerated process development.
A modular cell-culture platform demonstrates accelerated process development.
A modular cell-culture platform demonstrates accelerated process development.
The authors provide application data to support the use of SEC beyond small-scale operations.
The authors provide application data to support the use of SEC beyond small-scale operations.
The authors provide application data to support the use of SEC beyond small-scale operations.
The authors provide application data to support the use of SEC beyond small-scale operations.
Headspace moisture analysis is a rapid non-destructive analytical method that may potentially address the limitations of traditional methods used for residual moisture determination.
Cell concentrations and resulting protein concentrations are higher in a concentrated fed-batch process than in a standard fed-batch culture system.
Switching to single-use bioreactors can have financial and performance benefits.
Industry experts weigh in on best practices, challenges, and mutual recognition of cleaning validation standards.
AbbVie will acquire Stemcentrx and its lead late-stage asset rovalpituzumab tesirine (Rova-T), a novel biomarker-specific therapy derived from cancer stem cells.
The authors discuss the use of single-use bioreactors.
This article explores process modeling and compares process economics between a conventional upstream process and three perfused seed train alternatives
The pharmaceutical industry’s pipeline of new therapeutics has experienced a major shift from small to large molecules in recent years. As biopharmaceutical development expands, so too does the need for analytical techniques that address the key difficulties in this area. In Advances in Biopharmaceutical Characterization: Charge Variants and Aggregates, experts discuss overcoming the challenges of developing mAb formulations using novel pH gradient methods for ion exchange chromatography that provide fast and reproducible mAb charge variant profiling.