Search results for " monitoring"
Article
FDA Seeks Metrics to Define Drug Quality
Manufacturing standards are considered key to preventing drug recalls and shortages.
Critical drug shortages and contaminated compounding of sterile injectables have heightened public concern a…
Article
Operational Excellence: More Than Just Process Improvement
Monitoring the Environment
In addition, the site’s environmental monitoring (EM) results showed potential contamination, but because the results were segregated in the tracking system, personnel …
Article
Reviewing the Importance of Biosimilarity and Interchangeability
Developing a robust and reliable strategy for analytical studies of a biosimilar in development is crucial for a successful regulatory pathway. The importance of biosimilar products is tied to…
Article
Report from the 6th International HTPD Conference
These nanosensors are ~30 nm diameter and by using different types of incorporated fluorophores they are capable of monitoring pH values from 2.5-8.0. Results so far have been very promising, and the …
Article
A Look into Biologic Scale-Up Strategies
To maximize cell-culture output, strategy is required that takes into consideration factors such as cell culture media, environmental monitoring, and process controls. Yet, despite decades of process …
Article
Process Development and Control for New Modalities
Advancements in technology for manufacturing and online analytical monitoring have not caught up to the innovative drug candidates and emerging modalities present in the candidate pipeline today. Lack…
Article
Designing a 1.5 L Bench-Scale Model of a Perfusion Process
Establishing an appropriate model allows for higher throughput during simultaneous operation and monitoring of several cultures at different process conditions. In this article, we discus…
Article
Using Modeling to Improve Data Analytics for Upstream Bioprocessing Workflows
Recent trends in data analytics highlight the use of modeling techniques to improve process control and monitoring in biopharmaceutical production.
READ MORE >>
Article
Recent Trends in Data Analytics for Upstream Process Workflows
Modeling techniques can improve process control and monitoring in biopharmaceutical production.
Read more about it here >>
Article
Genetic Vaccine Platforms Demonstrate Their Potential
In a pandemic, genetic vaccines offer several advantages over traditional approaches.
By Cynthia A. Challener
For a vaccine to be effective, the components of the disease o…