Search results for " start"
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…
Article
Selecting a Comprehensive Bioburden Reduction Plan
Souza: Planning the design of a comprehensive bioburden reduction strategy should start with risk assessments for each of the entry routes. The identified risks and severity levels inform planning of …
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Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
Optimization of each phase in a chromatographic cycle has a positive impact on productivity.
By Anna Grönberg
An important area of focus for the biopharma industry is the elucidation and dev…
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
This article discusses cleaning validation of equipment dedicated to the production of a single API.
By Cristina Baccarelli, Paola Bernard, Teresa Cortellino, Oscar Cruciani, Rita Pacello, Chi…
Article
Breakthrough Drugs Raise Development and Production Challenges
The breakthrough designation “does not mean that sponsors can do less,” he said; they just “need to start sooner.” This may involve front-loading of crucial product and process characterization activi…
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ÄKTA Laboratory-Scale Chromatography Systems Handbook
This handbook is focused on liquid chromatography systems used for protein purification at research laboratory scale. Beginners can use the handbook to obtain an overview of how purification systems…
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Ensuring the Quality of Biologicals
The elaboration of biological monographs is a tiered process starting with the originator product, but the monograph may be subsequently adapted to account for biosimilar products. For complex biologi…
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USP Publishes Monoclonal Antibody Guidelines
In 2012, USP started working on a clearly defined set of quality expectations for recombinant therapeutic mAbs, United States Pharmacopeia (USP) General Chapter “Analytical Procedures for Recombinant…
Article
Quality by Design and Extractable and Leachable Testing
…nd USP Biological Evaluation, In Vitro (3) would be a reasonable minimal CQA for which to start.
CQAs for specific leachables are added after conducting extractable risk assessment. The relati…
Article
Ligand-Binding Assays and the Determination of Biosimilarity
“LBAs are certainly easier for starting a development campaign, but recent regulatory guidelines indicate that a cell-based MOA bioassay should accompany the development of a drug candidate as early a…