Search results for " equipment" in Articles / App Notes
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
BioPharm: Does the use of single-use systems (SUS) and/or equipment present any specific challenges or considerations when performing a risk assessment?
AstraZeneca: The use of SUS removes some of…
Article
Robust Optimization, Simulation, and Effective Design Space
A good understanding of the process or equipment capability will aid the developer in building the simulation (see Figure 4). Normal, truncated, and non-normal distributions are used to inject the sim…
Article
Modern Manufacturing Systems Key to FDA Quality Initiative
For certain high-risk situations, a manufacturer should consider adding manufacturing sites or lines, engaging additional raw material suppliers, and installing new equipment and technology.
The pr…
Article
Drug Discovery and Development in India
…ovation, limited access to high risk funding, short supply of skilled professionals, and specialized equipment.”
Low levels of intellectual protection continue to be a problem, Ang says. India re…
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What Drove Biopharma Development in 2014?
PDF readers also saw continued improvements and innovations in bioprocessing equipment and consumables. In 2014, there was significant increased interest in continuous processing, both upstream and do…
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Viral Clearance Challenges in Bioprocessing
Challenges remain for virus removal and validation.
Nov 1, 2014
By: Cynthia Challener, PhD
BioPharm International
Volume 11, Issue 27, pp. 42-44
Removal and inactivation of adventitio…
Article
Concentrating Feed—an Applicable Approach to Improve Antibody Production
In this study, the authors evaluated different approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture. By raising the pH or by adding surfactants, the fe…
Article
Gowning Practices Provide Clues to cGMP Compliance
Systems and equipment that may have been “top-of-the-line” to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today’s standards (1).
In a new facility, t…
Article
Outsourcing Trends in Biopharmaceutical Manufacturing
It’s also another indication that outsourcing is moving to higher-value areas --with that calculus not driven by cost considerations but instead by the equipment and expertise that CMOs offer that may…
Article
Predicting Progress in Protein Aggregation
In addition, the formation of larger precipitates can cause the physical clogging of equipment and handling of the product during downstream processing,” says Jesus Zurdo, head of innovation with Lonz…