Search results for "regulatory" in Articles / App Notes
Article
Navigating Emerging Markets: Middle East and North Africa
Key Regulatory Considerations
Regulations vary considerably across the region. Turkey, for example, has introduced market exclusivity as part of its efforts to become a European Union (EU) m…
Article
Report from the 6th International HTPD Conference
…ws of mechanistic modeling, a live software demo, but also a deep dive into case studies, status of regulatory acceptance of modeling, and further fields of application.
Learn more about th…
Article
A risk based approach to sterile filtration
Drug quality cannot be assured only by finished-product testing. Process validation is required to establish scientific evidence that a process is capable of delivering an effective and safe …
Article
Host cell protein quantitation using ELISA
Host cell proteins (HCPs) produced by cells during biologic manufacturing must be removed from the final product to protect patients. However, it’s challenging to detect HCP, and this step c…
Article
How to program, run and evaluate a design of experiments (DoE)
In this free, interactive course, Dr. Martin Sichting, Product Manager Lab Scale Chromatography Systems at Cytiva, guides you through the DoE process.
You’ll learn how to program, run, and e…
Article
What is process development?
Regulatory requirements will guide many of these activities.
At early stages of drug development, you will develop a process that is ‘good enough’ to meet the needs of that stage. However, it’…
Article
Top Process Development Trends for 2021 and a Look into 2022
The COVID-19 pandemic continues to shape bioprocess development trends, and many lessons have been learned from industry’s response to and preparedness for dealing with a public health crisis. Howev…
Article
A Stepwise Approach to a Digital Transformation in Biopharma
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An interview on “smart” manufacturing—a paradigm shift towards digital transformation for improved safety and quality, optimized performance, and increased complianc…
Article
How to Optimize and Scale Up AAV Production
In this article from a roundtable discussion, four experts from academia and industry met to discuss challenges in refining and scaling up AAV production pipelines to meet the increasing demand for …
Article
Single-Use Technologies Prove Effective for Viral Vector Process Development
The benefits of single-use technologies for upstream viral-vector processes clearly outweigh their disadvantages.
Cynthia A. Challener
Upstream viral-vector processes can have sig…