Search results for " containers" in Articles / App Notes

Article Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…

Article Techniques for Improving Process Development for Exosome-Derived Therapeutics
An interview with Aaron Noyes, Head of Downstream Processing at Codiak BioSciences Some therapeutic targets have long frustrated drug developers hoping to crack the code of mitigating un…

Article What's in Your SOP?
What’s in Your SOP? SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates. …

Article Evaluating Surface Cleanliness Using a Risk-Based Approach
Further consideration should be given to formulation, toxicity, analytical method for residuals, rinsability of components, stability of closed and open containers, and assurance that the product will…

Article Modeling and Miniaturization: Key Topics at Successful HTPD Conference
Modeling and miniaturization were two key take-home messages from the 4th High Throughput Process Development (HTPD) conference organized in October 2017 in Toledo, Spain. The conference brought tog…

Article Design and Qualification of Single-Use Systems
• Packaging and shipment containers must be designed to effectively protect the SUT component or assembly during transport from the manufacturing or assembly site, as well as ease and security of unpa…

Article Lessons Learned Accelerate Vaccine Development
Collaboration and single-use technologies aided the rapid scale-up of Ebola vaccine manufacturing. By Cynthia A. Challener Vaccine development is a complicated process that can take many yea…

Article The Metrics of Quality Culture
FDA’s proposed guidance for quality metrics raises questions about quantifying the tangibles and intangibles of quality culture. By Andrew Harrison, Susan J. Schniepp The long awaited, anxio…

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 Ensuring the Quality of Biologicals
May 02, 2015 By Stephen Wicks, PhD Pharmaceutical Technology Volume 39, Issue 5 The European Pharmacopoeia (Ph. Eur.), which celebrated its 50th anniversary in 2014, provides common …

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