Search results for "validation"
Article
Emerging Therapies Test Existing Bioanalytical Methods
Current FDA guidance provides little direction on how to approach assay development and validation when using these emerging technologies, nor is there guidance for the application of more familiar te…
Article
The Importance of Partnering for Bioanalytical Studies
FDA has issued guidance documents detailing the scope of bioanalytical method validation required for PK/PD endpoints, but it is also important to consider other regional guidance documents (e.g., Eur…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
The Chromeleon software also has an extension pack that includes validation report templates and sequences, enabling increased automation of method validation. More companies are implementing electron…
Article
Being Thorough When Transferring Technology
Ensuring quality and performing validation
BioPharm: What quality procedures specific to biologics must be put in place for technology transfer?
Lonza: Technology transfer processes are critic…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
The most recent FDA (1) and International Conference on Harmonization (ICH) (2-4) guidance documents advocate a new paradigm of process validation based on process understanding and control of paramet…
Article
Best Practices in Qualification of Single-Use Systems
…p-front capital investment
• No batch-to-batch cross contamination
• No re-use cleaning validation
• Less work on scale up
• Shortened time-to-patient.
When end users actually imp…
Article
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…
Article
Best Practices for Data Integrity
The risk of data manipulation is mitigated through validation and access. It’s hard to manipulate pen on paper; it looks obvious when something appears to be overwritten. How can you trust that comput…
Article
Establishing Acceptance Criteria for Analytical Methods
• FDA, Analytical Procedures and Methods Validation for Drugs and Biologics (6): “An analytical procedure is developed to test a defined characteristic of the drug substance or drug product against es…
Article
Mapping a Route for Cell and Gene Therapy Process Development
These factors make process development and validation for cell and gene therapies a challenging and highly critical task.
Scaling differences
Depending on the application (i.e., autologous vs.…