Search results for " business impact analysis"

Article Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
An approach for establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment. A critical quality attribute (CQA) has been defined as “a physical, chemical, …

Article Building a Business Case for Biopharmaceutical QbD Implementation (Peer Reviewed)
By Beth H. Junker. Beth H. Junker is the senior director of fermentation and development operations at Merck Research Laboratories ABSTRACT The aim of this paper is to de…

Article Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Surface plasmon resonance is helping define bispecific antibodies, the next-generation of biopharma therapeutics. By Robert Karlsson Abstract Biotherapeutic antibodies are still the larg…

Article Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle. With the most recent FDA …

Article Biopharma Advances Demand Specialized Expertise
Jun 15, 2015 By BioPharm International Editors BioPharm International eBooks Volume 28, Issue 13 Contract service providers share insights on biopharma market developments and the impl…

Article Moving PAT from Concept to Reality
The learning curve for process analytical technology has slowed widespread adoption. By Cynthia A. Challener alexlmx a- Stock.Adobe.com Process analytical technology (PAT) is…

Article Supply Chain Challenges for Single-Use Systems
Suppliers address the complexity of supplying disposable components to the global biopharmaceutical manufacturing industry. By Jennifer Markarian  The implementation of singl…

Article Reliability Rooms and the Move to Proactive Supply Chain Management
Reliability Rooms and the Move to Proactive Supply Chain Management Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict tren…

Article Challenging the cleanroom paradigm for biopharmaceutical manufacturing of bulk drug substances
The authors re-examine environmental controls in the context of technical advances in manufacturing.  By Simon Chalk, Scott Probst, Paul Gil, Tim Palberg, Matt Kennedy, Joe Rogalewicz, Jeff Johns…

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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