Search results for " activity" in Articles / App Notes
Article
Continued Process Verification for Biopharma Manufacturing
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Continued process verification (CPV) is the activity that provides ongoing verification of the performance of a manufacturing process. Guidance issued by FDA in 2011 (1) emphasized the impo…
Article
A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
This two-part Q&A series with Anurag Rathore, PhD, Professor, Department of Chemical Engineering, Indian Institute of Technology, Delhi, reveals the evolution of QbD, the types of companies implemen…
Article
Applying GMPs to the BioPharma Supply Chain
Defining best biopharmaceutical practices is necessary to ensure the safety of the supply chain.
Manufacturing biopharmaceuticals carries great responsibility. The drugs produced must be availab…
Article
Analyzing Proteins Using SEC, MALS, and UHPLC
In addition, Pothecary says that characterization of oligomers, which are ordered assemblies of multiple proteins, is important because oligomerization controls protein activity. Measurement of molecu…
Article
Biopharma Moves to Integrated, Single-Use, Downstream Processing
Suppliers see challenges to the adoption of single-use technologies for downstream processing as opportunities.
A lack of single-use technologies
The greatest barrier for adoption …
Article
Gowning Practices Provide Clues to cGMP Compliance
Review gowning practices as a tool to evaluate cGMP compliance in a facility.
The foundation of any successful quality-assurance system is strict adherence to good manufacturing practices (GMP…
Article
Trends in BioPharma Approvals in 2013
This glycocomponent normally contains a fucose sugar residue and removal of the fucose enhances antibody ADCC activity by up to 100 fold. Gazyva’s glycocomponent is enriched in non-fucosylated oligosa…
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
The Affordable Care Act's Impact on Innovation in Biopharma
The biopharmaceutical industry contemplates product innovation within the changing landscape of healthcare.
The Affordable Care Act (ACA) has elicited intense national debate and sent biopharm…
Article
Brazil Emerges as Global Biopharm Collaborator
Brazil is the first Latin American country to emerge as a global biopharmaceutical collaborator.
The pharmaceutical market in Brazil has been growing steadily and strongly in the past five ye…