Search results for " productivity"
Resource
Recovery of Biological Products XIX Conference
This international conference—taking place from July 12–17, 2020 in Rome, Italy—provides exposure to the latest developments in bioprocessing with a focus on downstream processing and aspects that aff…
Article
Increasing Productivity in Hydrophobic Interaction Chromatography (HIC) Using Capto™ Resins
In this study, the hydrophobicities of newer-generation Capto™ HIC resins were compared to Sepharose™ High Performance and Sepharose Fast Flow HIC resins. An application example is also present…
Poster
To Speed Up the Process Optimization of the Described Biosimilar Product
When establishing purification processes for a biosimilar molecule it is important to develop steps that are scalable, selective and cost effective.
This example describes a standardized workflo…
Poster
One-step seed culture expansion from one vial of high-density cell bank to 2000 L production bioreactor
This application note describes how perfusion cell culturing can be used to reduce processing time, simplify operations, and maximize equipment utilization in seed culture expansion processes.
Article
Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
With the dawn of the 2…
Article
QbD and PAT in Upstream and Downstream Processing
There are key performance indicators (KPIs) that are defined for upstream steps, including culture productivity (i.e., titer), cell growth, and viability. While KPIs may be correlated with CQA results…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
Historically, suitability has been evaluated utilizing phenotypic measures (productivity) assessing cell-line productivity across a generational span encompassing the manufacturing window. Given the v…
Article
Unifying Continuous Biomanufacturing Operations
Higher productivity per volume means companies can manufacture products at a faster rate. Lawrence Yu, PhD, deputy director in the Office of Pharmaceutical Quality at the Center for Drug Evaluation an…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…
Article
Biosimilar Quality Requirements
This article reviews FDA’s recent efforts to streamline the biosimilar approval process and address quality concerns with the publication of new guidelines that suggest resources to aid in the biosi…