Search results for " design"
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals’ most significant critical quality attributes and en…
Article
Reference Guide: Empty Chromatography Columns for Lab Scale
This guide offers an overview of Cytiva's empty chromatography columns designed for use in lab scale, including:
• Main technical specifications
• Compatibility with base matrix
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Article
New HiScale™ 10/40 for Scale-Down Studies
The robust design of HiScale 10/40 allows for controlled bed heights and gives reproducible results offering an effective scaled down model of the large-scale downstream process.
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Article
Nurturing Knowledge from Disparate Data Streams
“Broadly speaking, there are many organizations evaluating and using tools that were not designed specifically for pharma but perhaps for business or consumers, and these organizations have been adapt…
Article
Supply Chain Challenges for Single-Use Systems
A third challenge is that as suppliers (and the industry) evolve, product ratings, design, or supply chain sources may change, and it is critical to keep users informed. Transparency is a necessity, y…
Poster
Opportunities, Challenges, and Economic Drivers for Start-to-Finish Continuous Biomanufacturing
Adopting advanced process design will need an accurate business case and risk profile for implementation. Within the risk profile, assurance of patient safety and supply through product quality demons…
Article
Optimization of Fed‑Batch Culture Conditions for a mAb‑Producing CHO Cell Line
Process development was supported by a design of experiment (DoE) approach to reduce the number of cultures required to infer valuable information on how certain feed combinations influence culture pe…
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
EMEA, Note for Guidance on Virus Validation Studies: The Design, Contribution and Interpretation of Studies Validating the Inactivation and Removal of Viruses. CPMP/BWP/268/95, (London, revised 1996).…
Article
The Challenge of Disruptive Technologies in Bioprocessing
Creating a collaborative partnership to qualify, design, and supply materials for manufacturing can be an effective way to reduce non-core activities, address buffer bottleneck challenges, and focus o…
Article
Biopharma Seeks Balance
CDER’s Office of Pharmaceutical Quality has established an Emerging Technology Program to “promote the adoption of innovative approaches to pharmaceutical product design and manufacturing.” Biopharma …