Traditional project decision-making vs. a QbD approach.
A UC Berkeley survey provides insight into biopharma's risk concerns and strategies.
The authors present an overview of the types of RNA-based therapeutics in existence and their optimal methods of manufacture, purification, formulation, and delivery.
A twin-column periodic countercurrent capture process that combines an efficient sequential, countercurrent loading process with a minimal twin-column hardware configuration is described.
Quality control for disposable-bags
The US Supreme Court's Myriad decision satisfied both patient groups and patent holders
A UC Berkeley survey provides insight into biopharma's risk concerns and strategies.
An integrated focus on product design, development, operation, and control.
In this article, the author reviews some of the techniques that can yield valuable information on protein stability, focusing specifically on protein aggregation. Emphasis is placed on the enhanced information made available when technologies are used orthogonally, and the alignment of different approaches with specific stages of the biopharmaceutical development workflow.
Viruses in animal-derived starting materials could contaminate biopharmaceutical final product. A rigorous testing strategy and removal methods are reviewed.
The authors provide common misconceptions and key concepts behind reliability engineering.
The authors describe the growth characteristics of human mesenchymal stem cells cultured in a stirred-tank bioreactor.
A simple, sensitive, and universal platform for identification and quantification of trace-level protein impurities in biotherapeutics is described.
This article is the third and final in a series designed to offer leaders and managers at all levels in the industry a road map to excellence in human performance and human error prevention.
Can postapproval FDA filings immunize pharma companies from patent lawsuits?
Successful management of the CMO/client relationship should include open communication and trust.
In this question-and-answer discussion of "generic" biologics, the authors contend small changes in manufacturing of biologics dramatically affect the safety and efficacy of the therapeutic molecule.
The move to single-use manufacturing has prompted a paradigm shift in facility design.
A simple, sensitive, and universal platform for identification and quantification of trace-level protein impurities in biotherapeutics is described.
Traditional project decision-making vs. a QbD approach.
A new downstream purification platform using a salt-tolerant membrane adsorber.
Advances in cell culture media technology have helped achieve safer biologics.
Cellular and gene therapy fields are currently on track for, if not already experiencing, a serious capacity crunch.
The authors describe a new assembly for bulk and final drug product filling operations.