Search results for " safety"
Article
Webinar On-Demand: Novel Analytics to Improve Bioprocessing and Validation Guideline
At the recent Biotherapeutics Analytical Summit, Fredrik Sundberg presented the importance of implementation of a robust analytical control strategy to ensure drug product efficacy and patient safet…
Article
Single-Use for Downstream Chromatography: Benefit or Hindrance?
Hindrance or help?
Many disposable chromatography columns meet cGMP and industry standards, and also offer reproducibility, scalability, speed, ease-of-use, and operational safety.
However, chr…
Article
Fundamentals of Viral Clearance Studies with a Focus on Chromatography
These studies are an essential part of process validation and are critical to ensure drug safety. This article provides the basics of what you need to know when studying virus reduction of a chromatog…
Article
Supply Chain Challenges for Single-Use Systems
More attention is being paid to sterility and integrity of connections and valves and minimizing the need for operator interaction, which has a proven impact on time and safety of processes.
Isber…
Article
Modeling the Degradation of mAb Therapeutics
Modeling the Degradation of mAb Therapeutics
Kinetic models can be used to study aggregation and fragmentation to help ensure stability.
By Anurag S. Rathore, Rohit Bansal
…
Poster
Opportunities, Challenges, and Economic Drivers for Start-to-Finish Continuous Biomanufacturing
Within the risk profile, assurance of patient safety and supply through product quality demonstration will be critical.
This poster will highlight trade-offs and benefits associated with the adopt…
Resource
Plasma Product Biotechnology Conference
The sessions, compiled from submitted presentations, will cover the areas of manufacturing, quality, regulatory, pathogen safety, clinical development and technical innovations, and will chaired by re…
Article
The Challenge of Disruptive Technologies in Bioprocessing
“It is important to think about the biomanufacturing strategy early in the process to realize implications for flexibility, economics, safety, and logistics,” she says.
“Various operational cha…
Article
CDMOs Driving Emerging Bio/Pharma Success
…rted into physical products that can be safely and effectively administered to patients, and if that safety and efficacy can be demonstrated in clinical research. For that reason, CDMOs and contract …
Article
Making the Move to Continuous Chromatography
“This approach also allows a chromatography step to be run with less safety margins than would normally apply in a traditional batch process without loss of product,” she says.
Some systems com…