Search results for " production"
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
In this 28th article in the Elements of Biopharmaceutical Production series, the authors focus on the regulatory challenges that arise in the QbD paradigm, in particular on how review and inspection p…
Article
QbD and PAT in Upstream and Downstream Processing
This approach can lead in the determination of CQAs for the cell production bioreactor unit operation. Upstream outputs classified as CQAs have proven to be controversial, because the bioreactor is so…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
By Luhong He, Christopher Frye
Abstract
The Chinese hamster ovary (CHO) cell lines used for the production of recombinant therapeutic proteins are immortalized cells with a relatively high degre…
Article
Unifying Continuous Biomanufacturing Operations
But the continuous production of biologics in a closed, totally integrated stream--from “stem to stern”—still remains somewhat elusive, at least in commercial settings.
Early adopters of this “bio…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
…tream operations, and post-viral clearance operations; air pressure differential; HVAC; treatment of production water; control and appropriate filtration of production gases; waste treatment and wast…
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…