Search results for " regulatory"
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Filtration methods to overcome new challenges in viral safety
Read our article which summarizes the recent virus filtration regulatory changes in PDA Technical Report No. 41 and ICH Q5A, and outlines the detailed mechanisms governing effective virus filt…
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Bracing for a Future Wave of Advanced Therapies
Buoyed by the regulatory approval of several cell and gene therapy (CGT) products for difficult-to-treat diseases, the US biopharma industry is now bracing for a new wave of CGTs in the near future as…
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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…
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Planning for IND
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Learn how to navigate regulatory requirements as you progress through clinical trials to commercialization.
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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…
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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 …
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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.
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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…
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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…
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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,…