Search results for " design"
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Going Small to Achieve Success on the Commercial Scale
What counts as a scale-down model?
A scale-down model is a bench-scale process designed to predict the results that will be obtained when the process is run at commercial scale. Unlike initial pro…
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Fluid Handling in Biopharma Facilities
Disposables could represent a significant benefit in terms of facility design, validation, and investment. This trend will continue to grow as single-use systems increase a product’s speed-to-market a…
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Cleaning of Dedicated Equipment: Why Validation is Needed
As for non-dedicated facilities, equipment should be of appropriate design and adequate size and suitably located for its intended use, cleaning, and sanitation (2). Design and technical aspects of eq…
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Aseptic Processing: Keeping it Safe
Louis, MO campus, have spaces that are designed to handle media fill for various types of products and have isolators for both highly potent compounds and biologic products.
While investigational …
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What’s In a Name? For Biosimilars, A Lot
Name designation
BioPharm: Who has the final say when it comes to naming? USP or FDA?
USP: FDA has the final say, but only if it chooses to establish a name via notice and comment rulemaking. …
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Continued Process Verification for Biopharma Manufacturing
CPV and Quality by Design
Quality by design (QbD) means scientifically building quality into a product and the process by which it is developed and manufactured. QbD is based on the systematic ide…
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Challenges of Protein Aggregation During Purification
For example, certain CaptureSelect affinity ligands/resins from Thermo Fisher Scientific have been designed to favor elution under less acidic, more neutral pH conditions, according to Gebski.
Ref…
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Gowning Practices Provide Clues to cGMP Compliance
Quality must be built into the design of a facility to ensure that drugs are manufactured under conditions and practices required by the GMP regulations. This concept is broadly embraced across the gl…
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The Affordable Care Act's Impact on Innovation in Biopharma
To this end, clinical studies must continue to become more comparative by design, not just to the “gold standard” treatment, but also to non-pharmaceutical comparators and watchful waiting.
Simila…
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Enhancing Resins Addresses Purification Concerns
The key design parameters for the porous bead are the construction material, bead, and pore size, whereas the key design parameters for the ligand is the nature of the ligand and immobilized ligand de…