Search results for " industry"
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FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
Clinical development is crucial, but industry needs to have “manufacturing under control,” Marks observed.
More support
FDA’s Regenerative Medicine Advanced Therapy (RMAT) program can help exp…
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Challenges in Cell Harvesting Prompt Enhancements
The past decade has seen the biopharmaceutical industry move toward significantly higher titers, and, as a result, higher cell densities. Biomanufacturers have been shifting from large stainless-steel…
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Miniaturization to Become Even More Successful
The industry has turned to high-throughput process development (HTPD) methods—miniaturization, parallelization and automation in particular—to carry out the large number of experiments required for th…
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Automation Trend in Fill/Finish Reduces Contamination Risk
Handling sterile liquids in the pharmaceutical industry has traditionally relied on consistent techniques over the past 100 years, and changes in technology and regulations have been relatively slow, …
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Understanding Validation and Technical Transfer, Part 3
This third article in a three-part series (1,2) dealing with validation and technical transfer in the biopharmaceutical industry discusses validation of a non-traditional biopharmaceutical process, l…
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Putting Viral Clearance Capabilities to the Test
“A lack of appropriate scale-down models and strategies to support changes in industry practices such as continuous processing can restrict the design of the viral clearance study,” Smith says. “As ne…
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Applying GMPs in Stages of Development
The process used in the industry to determine root cause is, of course, the investigation procedure. This procedure, regardless of whether the product you are investigating is biotech or traditional, …
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ADC Development Robust Despite Lackluster Performance
This has led to an unfavorable attitude toward ADCs for some industry participants. Overall, however, the industry continues to believe in the clinical benefits of these drugs (1). Some examples of AD…
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Modeling and Miniaturization: Key Topics at Successful HTPD Conference
Ottens reviewed how knowledge-based chromatographic process development based on mechanistic modeling will become more important and more utilized in the industry in the coming years. He also emphasiz…
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Best Practices for Data Integrity
Best Practices for Data Integrity
Optimize practices and meet requirements using electronic data integrity systems.
By Jennifer Markarian
Maintainin…