Search results for "manufacturing" in Articles / App Notes
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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…
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Pharma Investments Reflect Key Industry Trends
“As a consequence, there is an opportunity to scale down biologics manufacturing, and newer facilities are typically based on 2000-L or smaller reactors and are much less cash-intensive, which is a ke…
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Gene Therapies Push Viral Vector Production
By now, a wide variety of AAV serotypes have been studied, adds Kai Touw, technical lead at Batavia Biosciences, a Netherlands-based contract development and manufacturing organization (CDMO). Some of…
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A Plastic Pipeline for Commercial Bioprocessing?
Pressure to get drugs to market faster, the smaller batch sizes characteristic of targeted therapies, and the comfort level biopharma companies and contract manufacturing organizations (CMOs) have wit…
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Fifteen Years of Progress: Biopharmaceutical Industry Survey Results
Manufacturing capacity issues have always been at the core of the annual survey, but as the industry has matured, the factors impacting capacity have become more complex.
This article highlight…