Search results for " industry"
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
Based on this forecast, the industry expects cell and gene therapy products to surge in the market and remain a prominent part of the pharmaceutical industry for years to come (2).
FDA has devel…
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Design Considerations for a Commercial Cell and Gene Therapy Facility
In mAb production, Chinese hamster ovary cells are the workhorse of the industry, and the process is mostly, if not completely, closed, notes Vanek.
Cell and gene therapies, on the other hand, c…
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Achieving Process Balance with Perfusion Bioreactors
“Perfusion is not a new concept in this industry but was perceived as too complex to run for many years. With recent availability of perfusion bioreactors and novel cell retention technologies, there …
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The Challenge of Disruptive Technologies in Bioprocessing
…p;D expenditure in biopharma companies are factors driving the growth of the global biomanufacturing industry, including downstream bioprocessing,” adds Orjana Terova, product manager, downstream, Th…
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CDMOs Driving Emerging Bio/Pharma Success
Analysts who track the industry expect 2018 to be the sixth straight year of substantial new investment in emerging biopharma companies from venture capital, public markets, and partnering. Funding fo…
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Biopharma Says It Has an Evolution in New Technologies and Processes
Rita Peters, editorial director of BioPharm International, shares observations of the magazine’s editorial team as they reported on industry developments at the April event.
Q: What insight did F…
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Evaluating Surface Cleanliness Using a Risk-Based Approach
The design and post-validation monitoring aspects are factored into the validation process, but are not specified in the regulatory guide nor in the industry practices. Today, this is referred to as t…
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Platform Technologies Improve Protein Expression
Challener
Speed to market is essential in the biopharmaceutical industry today. Manufacturers are seeking mechanisms for increasing efficiencies and reducing costs without compromising the…
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Advancing Single-Use Technology Through Collaboration
Some smaller suppliers may even decide that supplying to the biopharmaceutical industry is not worth the extra effort. In addition, manufacturers had been generating their testing methods for single-u…
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Efforts Accelerate to Streamline Postapproval Change Process
FDA and other regulators have sought to address these issues by encouraging industry adoption of continual improvement and quality-by-design approaches, along with change management protocols and life…