Search results for " design" in Articles / App Notes
Article
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 …
Article
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. …
Article
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…
Article
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…
Article
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…
Article
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…
Article
Technology Innovations Improve Process Chromatography Performance
It is of great importance to rely on materials, such as resins, buffers and equipment, which are designed for production purposes and available in the amount they are needed,” he states.
“The othe…
Article
The Importance of Partnering for Bioanalytical Studies
…ss of a new biological therapeutic?
Bose (Emery Pharma): Bioanalytical studies, which are designed to provide estimates for concentration of drugs and biologics in pre-clinical and clinic studi…
Article
The Need for Advanced Process Modeling for New Therapeutic Biologics
While QbD does not define manufacturing design space or specific protocols, it does discuss the need for a systematic approach to drug development and manufacturing. FDA believes that a QbD approach, …