Search results for " specification"
Article
Affinity chromatography Handbook - Vol. 3: Specific Groups of Biomolecules
Affinity chromatography (AC) separates proteins on the basis of a reversible interaction between a protein (or group of proteins) and a specific ligand coupled to a chromatography matrix. The techni…
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
In the next step, the authors assessed osmolality values of seven media and developed respective specifications based on analysis of several lots of material (Table III). The osmolality values are als…
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Establishing Acceptance Criteria for Analytical Methods
…y elements: cinical trials evaluting the pharmacokinetics (PK) response to drug product and dose and specification limits (1) of drug product and drug substance once clinical trials have demonstated …
Article
Quality by design for biotechnology products—part 1
Therefore, this paper offers guidance and interpretation for implementing QbD for biopharmaceuticals, from early-phase development steps such as identifying critical quality attributes and setting spe…
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A Closer Look at Affinity Ligands
Leached protein A is considered a CQA (critical quality attribute) to measure for with a release specification that must be met before the product can be released.Much progress has been made in recent…
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Using Quality by Design to Develop Robust Chromatographic Methods
…nd facilitates understanding in situations in which, for example, pass/fail criteria with respect to specification limits are being assessed). The concepts regarding how to express the uncertainty as…
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Eliminating Residual Impurities Starts with a Strategic Plan
“Some residual impurities, such as antibiotics and stabilizers, can be relatively easily defined and a strategy put in place that may include a limit specification in a release test or validating the …
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Emerging Therapies Test Existing Bioanalytical Methods
Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex thera…
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Gene Therapies Push Viral Vector Production
Gene Therapies Push Viral Vector Production
Viral vectors show promise as a delivery mechanism for gene therapy, but which virus types are commercially viable?
By Feliza Miraso…
Article
Best Practices in Qualification of Single-Use Systems
The implementation of SUS usually starts with development of the user requirement specification (URS). Typically, the development engineers at biopharmaceutical companies then work closely with the de…