Search results for " regulatory" in Articles / App Notes
Article
Maximum Output Starts with Optimized Upstream Processing
Development of rapid analytical methods; the use of robust inline, online, and at-line monitoring and testing capabilities to reduce the reliance on end-product testing, exploration of accelerated reg…
Article
Planning for IND
Click here to read more >>
Learn how to navigate regulatory requirements as you progress through clinical trials to commercialization.
Article
Updating Viral Clearance for New Biologic Modalities
Guidance is needed
Compounding all these challenges is the fact that published regulatory guidances have been based on traditional biologics, such as mAbs and related Protein A binders, says Berri…
Article
The Need for Advanced Process Modeling for New Therapeutic Biologics
The modeling approach can also bring early consideration to the regulatory aspects of drug development and future commercialization, allowing process developers to troubleshoot what may be regulatory …
Article
Using Software in Process Validation
Using Software in Process Validation
Software systems can help validate pharmaceutical manufacturing and steer the most appropriate design of processes in the right direction.
…
Article
Best Practices for Selecting a Top-Quality Cell Line
Given the number of potential factors that can influence cell-line quality, the increasing complexity of biologic drug substances and growing regulatory requirements, identifying the optimum cell line…
Article
Driving Improved Access to Biosimilars
Driving Improved Access to Biosimilars
New guidance from FDA, including standards for interchangeability, is expected to speed development of biosimilars, but experts warn against oversimplifying ri…
Article
Addressing the Complex Nature of Downstream Processing with QbD
Nowadays, it is a structured methodology for how to approach product development that is not driven by regulatory need, but rather internal needs related to the establishment of process understanding,…
Article
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Failing to demonstrate similarity can come at a significant cost and can trigger a more extensive (and expensive) clinical examination prior to receiving regulatory approval. Guidance documents from r…
Article
Nurturing Knowledge from Disparate Data Streams
Pharmaceutical scientists must be able to integrate and interpret these data in an efficient manner that ensures reliability, security, and regulatory compliance.
Digitalization creates difficulti…