Search results for " FDA"
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The Bullish Outlook for Biosimilars
Unique to the US, FDA will designate these follow-on biologics as either ‘biosimilar’ or ‘interchangeable biosimilar’ based on the level of evidence submitted. While there is still plenty of uncertain…
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Quality by Design and Extractable and Leachable Testing
The FDA guideline states that CQAs are generally associated with drug substances, excipients, intermediates, and drug product, but the concept can also be applied to container closure systems. While i…
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
As the pharmaceutical industry tries to embrace the methodologies of quality by design (QbD) provided by the FDA’s process validation (PV) guidance (1) and International Conference on Harmonization (I…
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Essentials in Establishing and Using Design Space
FDA generally welcomes discussion on design space with applicants so be sure to discuss the design space and submission logic with FDA working groups as needed.
References
1. ICH, Q8(R2) Pharm…
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Biosimilars Development and Supply: How Complex Can the Process Be?
FDA defines “drug shortages” as “a situation in which the total supply of all clinically interchangeable versions of an FDA-regulated drug is inadequate to meet the current or projected demand at the …
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The Need for Advanced Process Modeling for New Therapeutic Biologics
The Need for Advanced Process Modeling for New Therapeutic BiologicsThe trend toward personalized medicines includes more complex manufacturing cycles that can benefit from advanced process modeling e…
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Methods Accelerate Biosimilar Analysis
In May 2019, FDA published a draft guidance on the analytical assessment and other quality-related considerations for biosimilars, clarifying regulatory requirements and expectations for demonstration…
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Applying GMPs in Stages of Development
Applying GMPs in Stages of Development
Regardless of the phase of development and the level of GMPs being applied, there should be adequate controls and knowledge to assure patient safety, …
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Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
Last year also marked a significant step towards integrating continuous manufacturing into pharmaceutical production for a small-molecule drug when FDA approved, for the first time, a manufacturer’s c…
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Defining Risk Assessment of Aseptic Processes
In September 2004, FDA finalized their guidance for industry titled Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice (1).
This document placed considerable e…