Search results for " scalability" in Articles / App Notes
Article
A Plastic Pipeline for Commercial Bioprocessing?
A Plastic Pipeline for Commercial Bioprocessing?
The maturation of single-use technologies presents commercial bioprocessing options for small-volume drug products.
By Rita C. Peters
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Article
Making the Move to Continuous Chromatography
“In this instance, there is a great benefit of starting from the process development step to document scalability,” he notes.
The discussion topic for Sulzberger focuses on whether there is su…
Article
Understanding Validation and Technical Transfer, Part I
The molecule originally identified as possibly having clinical significance must be fully characterized and its synthesis routes developed with the aim of scalability. Formulations to be used in clini…
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Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
The method also has the potential for scalability. Careful analysis of the combined effect of both stimuli on the cells and on the subsequent processing of the product, however, is necessary. Apart fr…
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Going Small to Achieve Success on the Commercial Scale
As a result, it is more difficult to adequately demonstrate the scalability of the models to the level required for qualification,” Jorjorian says. He adds that there is a lot of effort being devoted …
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Taking a “Development-by-Design” Approach to Cell Therapies
“The goal is to develop a mix of equipment and manufacturing strategies that maximize quality, scalability, and sustainability, with an eye toward cost-effectiveness and commercial viability,” Grant s…
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Modular Manufacturing Platforms for Biologics
May 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 5
It should come as no surprise that the good design principles governing the execution of pharmaceutical manu…
Article
Q&As with Industry Leaders
Discovering the unknown: How does in silico process development change PD scientists’ work?
Jeanne Linke Northrop, BioPharm International
Nora Ketterer, Manager, Modeling Services…
Article
Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
That includes careful selection of equipment and starting materials with scalability and manufacturability under current GMPs taken into consideration and being guided by data, not perception.
“The…
Article
Alternative solutions to separate AAV full and empty capsids using anion exchange
Adeno-associated virus (AAV) is the main vector for gene therapy and there is need for scalable, cost-efficient, and robust chromatography-based purification. Key for a successful process are …