Search results for " specification"
Article
Challenges in Analytical Method Development and Validation
In some cases, product specifications may need to be re-evaluated and potentially adjusted to the established bias and/or increased sensitivity of the new method.
Regulatory expectations vary a li…
Article
Leveraging Data for Better Biopharmaceutical Process Control
Leveraging Data for Better Biopharmaceutical Process Control
The need to improve and understand processes is moving PAT and more advanced control strategies beyond the lab into manufacturing and dow…
Article
Supplier-Change Management for Drug-Product Manufacturers
As a result, companies making these products perform extensive studies to validate that the materials, equipment, and processes used for manufacturing consistently produce products that meet specifica…
Article
QbD and PAT in Upstream and Downstream Processing
However, if a strong correlation can be established between VCD/viability and other CQAs or final product specifications, this can be an appropriate approach.
Girard (Spinnovation): The underlying…
Article
Understanding Validation and Technical Transfer, Part 3
A product specification will be developed on the basis of initial development information.
The product specification includes tests, analytical procedures, and acceptance criteria defining the …
Article
Understanding Validation and Technical Transfer, Part I
…lished a series of documents that, among other things, relate to process validation: Q6B for setting specifications for biotechnological and biological products (8), Q7A for active pharmaceutical ing…
Article
Single-Domain Antibodies for Brain Targeting
Single-domain antibodies are emerging as credible alternatives due to their target specificity, high affinity, and cost-effective recombinant production.
Smaller recombinant antibody fragments a…
Article
Managing Residual Impurities During Downstream Processing
It incorporates choice of method; aspects of assay performance to be evaluated to demonstrate method validity, including critical reagent identification, retention, and planning; and provides general …
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
ICH, Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, Step 4 version (September 1999).
7. FDA, Guidance for Industry, Bioanalytical…
Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
Olivier Le Moal/Stock.Adobe.com
By Cynthia A. Challener
Facility and equipment design are important, but the team and its experience matter most.
Through its Operation Warp Speed pro…