Search results for " product safety"
Article
Accelerated flavivirus vaccine production with modern tools and solutions
Flavivirus vaccine development and production constitute many challenges and can be both space-and resource-consuming. This white paper gives an overview of modern tools and solutions, adding flexib…
Resource
Plasma Product Biotechnology Conference
The Plasma Product Biotechnology Conference Series, now in its 12th year, will provide a topical and stimulating program detailing the latest developments of importance to the industry. The sessions…
Poster
Biacore™ systems in vaccine development and production
The growing public awareness of a potential pandemic requiring rapid treatment of millions of healthy individuals has spurred renewed interest in vaccines. Vaccination campaigns mean that often very…
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
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Although a plethora of regulatory guidance documents have been enacted governing product safety from adventitious agents (1–16), complete risk elimination has not yet been achieved. Several examples o…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells.
By Luhong He, Christopher Frye
Abstract
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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…
Article
Reimagining Affordable Biosimilars
Failure rates of clinical trials Clinical studies often provide the final verdict on product safety and efficacy, and while this may also be true for biosimilars, it is not the most conclusive exercis…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
The FDA talks about the changing scope of regulatory science.
Regulatory science underpins innovation and practices in drug manufacturing. The most common definition of r…
Article
Platform Approach Speeds Process Development
A modular cell-culture platform demonstrates accelerated process development.
By Harald Bradl, Jan Bechmann, Benedikt Greulich, Markus Michael Mueller, Patrick Schulz, Thomas Wucherpfennig
C…