Search results for " supply"
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Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
Another driver pushing developers to consider suspension cell lines is the desire to move away from serum for biosafety, cost, supply, and processing needs. However, as it will be explained later, the…
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Genetic Vaccine Platforms Demonstrate Their Potential
Often, long lead-time items with long expiry dates can also be held in stock, decreasing the time necessary to order, release, and supply material to the manufacturing or QC [quality control] suites,”…
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Strategizing for Rapid Changeovers in Biologics Manufacturing
Properly optimizing cleaning and sterilization cycles where stainless-steel equipment is used, validating procedures, having a well-trained staff, and having a robust yet simplified supply chain are k…
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Gene Therapies Push Viral Vector Production
“At the present time, there is currently a shortage of vector supply driven by the rapid growth of gene therapies both in vivo and ex vivo,” adds Vicaire. The shortage in viral vector supply is also u…
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Optimizing Late-Stage and Commercial Cell-Culture Processes
Cell-culture hurdles
The ability to maintain a reliable supply chain is one of the challenges in cell-culture processing. The security of obtaining supply for raw materials with the desired profil…
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Understanding Validation and Technical Transfer, Part 2
Earlier activities include vendor qualification of the coffee supplier and roaster, qualification and validation of the water supply system, validation of the equipment cleaning processes, and any cal…
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Modern Manufacturing Key to More Effective Vaccines
He noted that continuous manufacturing platforms can help ramp up vaccine supply on short notice and that FDA clarification of its requirements and standards should encourage industry investment in ne…
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Roadmap Leads to Innovative Biomanufacturing Strategies
These companies had the most experience in the direct supply of drug to patients. It was clear from the beginning that the full benefit of the roadmap would eventually only be realized with the partic…
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Contract Manufacturing Through the Years
This reflects the fact that the small-molecule API technology and supply base are quite mature, so the global bio/pharma companies can confidently hand off their small-molecule needs to CMOs while the…
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The New World of Biopharmaceutical Manufacturing
Since the implementation of single-use systems involves a partnership with suppliers, robust and transparent supply chains to the customers are critical.
Linz (Sartorius): The industry…