Search results for "manufacturing"
Article
Design and Qualification of Single-Use Systems
Martin
Single-use technologies (SUT) have made significant inroads in biopharmaceutical and vaccine manufacturing. Greater adoption in the years to come can be anticipated, given their broad use i…
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Technologies and Practices Must Evolve to Meet Demand
In the annual Manufacturing Trends and Outlook survey, the editors of BioPharm International polled bioprocessing development and manufacturing experts to assess challenges, preferences for different …
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PDA's Technical Report for Biotech Cleaning Validation
Cleaning validation plays an important role in reducing the possibility of product contamination from biopharmaceutical manufacturing equipment. It demonstrates that the cleaning process adequately an…
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Mapping a Route for Cell and Gene Therapy Process Development
These products are highly complex and often involve production methods that, while in some ways are similar to those used in biologics and vaccine manufacturing, in many ways are quite different.
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Unifying Continuous Biomanufacturing Operations
The most efficient upstream processing systems in biologics manufacturing seek to mimic the body’s treatment of cells, so a constant level of incoming nutrients and outgoing waste products is necessar…
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Ensuring Sterility in Small-Scale Production
The best advice is to consult the regulations and determine what requirements you must meet to help ensure the clinical material you are manufacturing is safe.
Clinical-trial material batches can …
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Managing Biomanufacturing Capacity Expectations
…were identified as the top things the industry must do to avoid further capacity restrictions at biomanufacturing plants (Figure 1). Analytical testing concerns and adequate hiring of qualified perso…
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Quality Systems Key to Lifecycle Drug Management
And new policies and procedures at FDA aim to streamline oversight of manufacturing changes for firms that adopt modern production methods able to ensure the continued safety and efficacy of products …
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Understanding Validation and Technical Transfer, Part I
Large-molecule drug products and attendant manufacturing processes often involve complex syntheses and purification steps that differ substantially from those employed for small-molecule pharmaceutica…
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Advanced Technologies Facilitate Scale-up and Technology Transfer
“Single-use systems have proven to not only reduce capital investment, but also minimize turndown time, resulting in more effective and higher-quality manufacturing processes for scale-up and tech tra…