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Managing Biomanufacturing Capacity Expectations
Capacity for complex therapeutics is becoming increasingly difficult to predict.
By Randi Hernandez
Demand for any given new product is typically only known after significant investments h…
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Advanced Technologies Facilitate Scale-up and Technology Transfer
He notes that the system is flexible because the production process supports bespoke operations meeting customer requirements in full, and adaptive because the modular nature of the system enables poi…
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Continuous Manufacturing: A Changing Processing Paradigm
An agency representative said at an International Forum and Exhibition on Process Analytical Chemistry Annual Meeting in 2012 that the on-line monitoring characteristic of continuous processing can fa…
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HTPD 2023 conference is coming up. What will be discussed and what happened last time?
The Organizing Committee, invite you to the 6th HTPD meeting and look forward to meeting you in Malta in October 2023.
If you want to have reminder on the topics that was discussed at the last HTP…
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Updating Viral Clearance for New Biologic Modalities
New product innovations and the establishment of new operating conditions for legacy products have been instrumental to meeting evolving processing needs, Verlenden adds. As an example, he points to r…
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Successfully Moving Regulated Data to the Cloud
In light of recent FDA guidance on data integrity, the challenges and benefits of using the public cloud to deploy and use data management software are discussed.
By Stuart Ward
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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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Design and Qualification of Single-Use Systems
Attendance at industry meetings, participation on scientific association SUS committees, or trade associations such as BPSA provide important access to suppliers, integrators, and users to aid in dete…
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Tools for Continuous Bioprocessing Development
Could perfusion microbioreactors bring more agility to biomanufacturing?
By Rajeev J. Ram
In semiconductor manufacturing, for example, a thorough understanding of process variation allows co…
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Breakthrough Drugs Raise Development and Production Challenges
Expert review teams in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are meeting deadlines and goals for assessing breakthrough designa…