Search results for " biopharmaceutical"
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Biopharmaceutical Market in Asia: Q&A with Günter Jagschies, Strategic Customer Relations Leader, Cytiva
India and China have a strongly growing and well-funded biopharmaceutical industry focusing primarily on biosimilar proteins with several hundred projects in the pipeline. India is also in a leading p…
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Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
Single-Use Technologies Are Still Growing—But Not Without Challenges
Single-use technology is said to offer a plethora of benefits in the production of biopharmaceuticals and biosimilars, includin…
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Mechanistic Modeling: Current Advantages and Future Opportunities in Biopharmaceutical Process Development
The implementation of advanced process analytical technologies (PAT), especially online real-time monitoring could further accelerate the roll-out of mechanistic modeling in the biopharmaceutical indu…
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Continuous Processing for the Production of Biopharmaceuticals
There have also been new efforts by various regulatory organizations to encourage continuous processing for the manufacturing of biopharmaceuticals. Both FDA and the European Medicines Agency (EMA) ha…
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Flexibility in Biopharmaceutical Manufacturing
Compared to other industries, biopharmaceutical supply chains have been stuffed with inventory that effectively decouples manufacturing supply from customer demand. This makes the job of running the p…
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Digital transformation of biopharmaceutical process development
Digital transformation has become an increasingly important topic for the biopharmaceutical industry as it leads to new opportunities for additional value creation and competitiv…
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Approaches to Improve Efficiency in Biopharmaceutical Process Development
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Time to experiment, time to clinic, and time to market are becoming even more important for developers and manufacturers of biopharmaceuticals. This a…
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Considerations for Improving Outcome in Biopharmaceutical Process Development
In this article, we take a look at how the process outcome can be improved by increasing the performance and robustness of the bioprocess workflow through a variety of critical aspects, different stra…
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State of Quality and Compliance in the Biopharmaceutical Industry
Have FDA initiatives improved manufacturing quality?
The late 1990s and early 2000s witnessed a slew of enforcement actions by FDA that included multiple Form 483 observations, warning le…
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Biopharma Advances Demand Specialized Expertise
… contract development and manufacturing markets, are just two indicators of the ongoing evolution of biopharmaceutical development. Representatives of contract service providers shared observations, …