Search results for " supply"
Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
There were many questions about dealing with variability in raw materials, evaluation of stability, and addressing unique supply chain issues.
Bryan Silvey, senior director for quality compli…
Article
Patenting Prospects for Cell-Based Therapies
This type of cell has a short lifespan that resulted in erratic supply as well as limited and unreliable availability.
The inventors found, contrary to the understanding in the prior art, that …
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
The authors review how media components modulate the quality of monoclonal antibody products.
By Anurag Rathore, Rajinder Kaur, Dipankar Borgayari
Recombinant protein products have…
Article
Unifying Continuous Biomanufacturing Operations
“Integrating up and downstream R&D often does not mean each unit operation is developed and integrated continuously with others, since equipment supply is mostly from different vendors for each unit o…
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Speed and Flexibility Are Dual Goals for Biopharma Operations
Bioprocessing facilities, equipment, and materials, as well as strategies to improve biopharmaceutical development and manufacturing, were featured at INTERPHEX 2017, held in March in New York City.…
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
Alternatively, upstream process scale-up can make use of perfusion reactors, which use a constant supply of cell-culture media while removing unwanted byproducts throughout a prolonged production run …
Article
Single-use Bioreactors Have Reached the Big Time
Measurable progress
“Driven by this high demand, the supply chain for disposable or single-use technologies has become more robust, covering more technologies than before and meeting the growing e…
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Evaluating E&L Studies for Single-Use Systems
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
By Irene Cecchini, Daniele Mastroianni, Silvia Rocchi, Gabriella Angiuoni
Biop…
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The Tide Stays High
Robust venture capital investment gives CDMOs and CROs a positive outlook for 2017.
By Jim Miller
A year ago, the outlook for contract services was a little uncertain. Equity markets’ appeti…
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Efforts Accelerate to Streamline Postapproval Change Process
By Jill Wechsler
Frequent revisions and updates in manufacturing processes and operations are routine after a drug comes to market to improve products and systems and ensure reliable supply of hig…