Search results for " assays" in Articles / App Notes
Article
Challenges in Analytical Method Development and Validation
The new draft guidance does not address specific method validation recommendations for biological and immunochemical assays.
Quality by Design
BioPharm: How can method validation benefit from a …
Article
Manufacturers Struggle with Breakthrough Drug Development
The same principles and requirements for setting initial shelf life apply to breakthroughs, Shacter noted, so manufacturers should look to identify stability-indicating assays early. It may be possibl…
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Outsourcing Trends in Biopharmaceutical Manufacturing
Beyond typically outsourced activities like fill-finish, validation services, and assays, companies are increasingly relying on their suppliers to address more challenging processes. From expertly pac…
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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…
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Evolution of the Monoclonal Antibody Purification Platform
The authors discuss the evolution of the purification platform for manufacturing of mAb therapeutics.
Monoclonal antibodies (mAb) increasingly form the majority share of the product pipeline…
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FDA Seeks Metrics to Define Drug Quality
Manufacturing standards are considered key to preventing drug recalls and shortages.
Critical drug shortages and contaminated compounding of sterile injectables have heightened public concern a…
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Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
She stressed that efforts should be made to better control the presence of HEV by harmonization of the worldwide assays and possible also implementing heat treatment to the relevant plasma products to…
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Biosimilars Development and Supply: How Complex Can the Process Be?
Unlike the development of small molecules, several bioanalytical assays are necessary in the early development of biologics, which are typically produced within engineered cells from pharmacologically…
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The Development and Application of a Monoclonal Antibody Purification Platform
A purification scheme to maximize the efficiency of the purification process and product purity while minimizing the development time for early-phase therapeutic antibodies.
The following ar…
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PDA's Technical Report for Biotech Cleaning Validation
The authors encourage biotech manufacturers to consult PDA Technical Report No. 49 for a detailed perspective on current practices and issues in biotech cleaning validation.
By Anurag S. Rathore, D…