Search results for " process"
Article
Evaluating Design Margin, Edge of Failure and Process
46-49
A product’s or process’ design space is generally considered to be the area where process parameters safely (without failure or high amounts of degradation) can be processed and achieve al…
Article
The Importance of Process Intensification and PAT for Achieving Real-Time Release
Workflows, capital and operating expenses, product quality, and waste production can all be positively impacted by the efficiency gains possible with process intensification.
…
Article
Discovering the unknown: How does in silico process development change PD scientists’ work?
But what does it actually mean to perform process development in silico? Do I need to be a math expert? Where is modeling applicable? Will I not set foot in the lab ever again?
Transcript
…
Article
Top Process Development Trends for 2021 and a Look into 2022
However, the focus in 2021 shifted beyond the pandemic to optimization and scaling up adeno-associated virus (AAV) production, process workflows and considerations for messenger RNA (mRNA) therapeutic…
Article
Generating a Fully Processed Antibody
In the case of a protein needing cleavage or another post-translational modification, the modifying protein needs to be produced at high enough levels to fully process all the biopharmaceutical at hig…
Article
Using Software in Process Validation
By Robert Glaser
Within pharmaceutical manufacturing, the goal of process validation is to build quality into the operation at every step to ensure consistent product quality. It seems straig…
Article
Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
What might be in store for 2019, and what important lessons should process developers take from 2018? Here, we look back at some of the most popular Process Development Forum articles from 2018 for cl…
Article
Process Development: 2020 Reflections and 2021 Possibilities
Among the many vaccine challenges in relation to the urgency provoked by COVID-19 are safety and the ability to scale up the manufacturing process. Scaling up viral vector and virus manufacturing proc…
Article
Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
The white paper includes a brief discussion around modern vaccine processes, followed by a case study showing the scale-up of upstream and downstream processes for the production of a cell based live …
Article
Monitoring and Control of Inline Dilution Processes
Challener
Process intensification is a major focus of the biopharma industry, with most efforts targeting upstream cell culture and associated processes. Buffer management has received les…