Search results for " development"
Article
Applying GMPs in Stages of Development
We have clients with products in various stages of development that are using multiple contracts with multiple services providers for various stages of the manufacturing process. I always struggle wit…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.
The concept of quality by des…
Article
Design of Experiments for Analytical Method Development and Validation
Design of experiments (DOE) is a well-proven characterization approach within product and process development and a key aspect of quality by design. Recently, more attention has been placed on applyin…
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
Single-Use Technologies Prove Effective for Viral Vector Process Development
Single-use options from lab to commercial scale
A variety of different single-use systems are used for viral vector production depending on the phase of development, required production scale, t…
Article
Techniques for Improving Process Development for Exosome-Derived Therapeutics
Here, the Process Development Forum speaks with Aaron Noyes, Head of Downstream Processing, at Codiak BioSciences about exosomes, their potential clinical applications, and process innovations that wo…
Article
The Development and Application of a Monoclonal Antibody Purification Platform
The following article describes the development of a purification platform for monoclonal antibodies (MAbs) at Pfizer's Global Biologics division, including how the individual unit operations have bee…
Article
Top challenges in recombinant protein purification process development
I'm really looking forward to this discussion today on recombinant protein purification process development.
In the industry, we're seeing recombinant proteins more often, right? And we're seeing …
Article
Process Development: 2020 Reflections and 2021 Possibilities
To shed light on what 2021 could have in store for the industry, let’s take a look at the Bioprocess Development Forum articles from 2020 that readers found most interesting and relevant during such a…
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…