Search results for " patients" in Articles / App Notes

Article CoAs Help Secure the Supply Chain
The safety of the pharmaceutical supply chain is of concern to regulators, manufacturers, practitioners, and patients. The process of assuring the suitability of suppliers of pharmaceutical ingredient…

Article Modern Manufacturing Key to More Effective Vaccines
Sanofi recently halted distribution of its dengue fever vaccine in the Philippines after some patients developed the disease following injection (2).  Such setbacks fuel anti-vaccine campaigns …

Article Evaluating Surface Cleanliness Using a Risk-Based Approach
Evaluating Surface Cleanliness Using a Risk-Based Approach Rinse sample analysis or visual inspection can be correlated to surface cleanliness to replace surface sampling. By Elizabeth Rivera…

Article Downstream Processing for Cell-Based Therapies
By Qasim A. Rafiq, Fernanda Masri With increasing numbers of advanced therapies—including cell and gene therapies—entering early- and late-stage clinical development, significant focus has been …

Article Single-use Bioreactors Have Reached the Big Time
The decision to use disposable bioreactors is now driven by commercial rather than technological considerations. By Cynthia A. Challener Single-use bioreactors available from various vendors…

Article Ensuring Sterility in Small-Scale Production
Finally, there needs to be consideration to final product testing and the appropriate number of samples needed to ensure the product is sterile and safe for patients. The samples needed for testing sh…

Article Evaluating E&L Studies for Single-Use Systems
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials. By Irene Cecchini, Daniele Mastroianni, Silvia Rocchi, Gabriella Angiuoni Biop…

Article Defining Risk Assessment of Aseptic Processes
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs. By Susan J. Schniepp Q: I work in …

Article Microbiological Testing: Time is of the Essence
Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing methods. By Cynthia A. Challener Effective microbiological testing during biopharmace…

Article Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
The challenges and strategies of assessing and mitigating risk in biopharmaceutical manufacturing are discussed. Jul 01, 2015 By Susan Haigney BioPharm International Volume 28, Iss…

Show All Results

Previous PageNext Page