Search results for " process" in Articles / App Notes
Article
Industry Adoption of Single-Use Systems Remains Low
Single-use equipment offers the benefit of making the biomanufacturing process increasingly efficient and less costly, which makes it particularly attractive for smaller and lesser-funded companies. F…
Article
Fusion Proteins Pose Manufacturability Challenges
Combining two different proteins in one molecule can lead to instability, which creates manufacturing challenges during both upstream and downstream processing. Solutions for overcoming these issues a…
Article
Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
Despite the advent of regulations and technical capabilities, market leaders at Interphex 2016 expressed their confidence to Process Development Forum that continuous processing, ripe with innovation,…
Article
Design and Qualification of Single-Use Systems
With increasing regulatory oversight of SUT processes, it’s worthwhile to review basic concepts of design and qualification that apply to single-use components and systems (SUS).
Equipment Design …
Article
A Q&A on Bioprocessing Trends and Technologies at INTERPHEX 2016
A number of equipment manufacturers announced new bioreactors, fermenters, tanks, and other process-related equipment as the move toward single-use systems in commercial manufacturing moves forward.
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Article
Securing the Single-Use Supply Chain
Large-scale impact
Today, single-use systems are used throughout the entire process chain from upstream to downstream and from bench scale to production scale. In the past, when drugs were manufac…
Article
Quality by Design—Bridging the Gap between Concept and Implementation
… summarized the main concerns as being the classifying of criticality, levels of details required in process descriptions and in risk assessments, design-space verification, and changes to non-critic…
Article
Lessons Learned from the Biopharma Industry's Response to the COVID-19 Pandemic
Topic covered include:
1:38 – The typical time frame for process design and process qualification for a biopharmaceutical development program
2:10 – The driving forces for the rapid scal…
Article
Hybrid Bioprocessing: A Q&A with Andrew Sinclair
Hybrid processing is not a very precise term and it used indiscriminately. In my view, it's where within the manufacturing process, there are a combination of single-use (SU) materials and re-usable m…
Article
Managing Biomanufacturing Capacity Expectations
“Either the manufacturing process was not as robust as the sponsor thought it was, or the tech transfer failed to successfully convey all subtleties to the contract manufacturing organization [CMO].” …