Search results for " guidelines"
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…
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
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
In 2013, the agency also issued a draft concept paper on the comparison of biosimilars with reference products; the similarity guidelines and clinical and non-clinical requirements were updated, and a…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle.
With the most recent FDA …
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
T…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
A…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
…or protein characterization studies, and these methods can be readily validated following regulatory guidelines. Further technological advancements in sample preparation throughput and data handling …
Article
Quality by design for biotechnology products—part 1
… John Towns
ABSTRACT
The International Conference on Harmonization (ICH) Q8(R2), Q9, and Q10 guidelines provide the foundation for implementing Quality by Design (QbD). Applying those concept…
Article
Mechanistic vs Statistical Models
Mathematical models are recommended by the ICH Q8 guidelines on pharmaceutical development to generate enhanced process understanding and meet Quality-by-Design (QbD) guidelines. Read on the d…
Article
Reimagining Affordable Biosimilars
Concepts of “totality of evidence (ToE)” and “confirmation of sufficient likeness (CSL)” have been added and more recently edited from the regulatory guidelines (29,30).
Regulatory changes have …