Search results for " specification" in Articles / App Notes
Article
Technology Innovations Improve Process Chromatography Performance
As technology matures, inefficiencies and process limitations in downstream process chromatography are improved.
By Feliza Mirasol
Selecting an appropriate separation technology fo…
Article
Purposeful Design and Development of a Next Gen Single-use Bioprocess Film
Cytiva recognizes the need for a film constructed specifically to meet the complex bioprocessing nature of a multitude of biologics.
Introducing Fortem™ film, a platform film technology built spe…
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Mapping a Route for Cell and Gene Therapy Process Development
In addition, the downstream processing steps can vary significantly depending on the product specifications and available downstream technologies, such as tangential flow filtration, counter-flow cent…
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
The Evolving Role of Starting Materials in Cell and Gene Therapy
Accelerated approval pathways and growing demand for cell and gene therapies are putting pressure on providers of cellular starting m…
Article
Driving Improved Access to Biosimilars
Driving Improved Access to Biosimilars
New guidance from FDA, including standards for interchangeability, is expected to speed development of biosimilars, but experts warn against oversimplifying ri…
Article
Moving PAT from Concept to Reality
The learning curve for process analytical technology has slowed widespread adoption.
By Cynthia A. Challener
alexlmx a- Stock.Adobe.com
Process analytical technology (P…
Article
Science Focus Fuels Successful Process Development for Startups
“It does no good to have a great idea if it cannot be translated into an efficient, practical, scalable, cost-efficient process that meets specifications and regulatory requirements and can be used to…
Article
Scalable Viral Vector Manufacturing
The interest for robust and scalable viral vector manufacturing is rapidly increasing, with the recent developments of both cell and gene therapy and oncolytic virus-based therapies. As cost pressur…
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Establishment of New Modern Plasma Fractionation Facilities in Asia
This week, the Process Development Forum talks to Dr. Neil Goss, an international consultant in biotechnology and plasma fractionation, past director of Research and Development at CSL BioPlasma, Aust…
Article
Putting Viral Clearance Capabilities to the Test
Process understanding and careful assessment of risks are essential in developing viral clearance programs.
By Rita C. Peters
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