Search results for " supply"
Article
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…
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From Darwin to Recombinant Fc Multimers
no biosimilars
• Continued innovation, investment and progress
To ensure future vitality of the industry, Perkins talked about the importance of securing plasma supply, donor and patient safet…
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Being Thorough When Transferring Technology
Many cell therapies are personalized medicines and these represent unique challenges from a manufacturing and supply chain standpoint. One of the things that can aid greatly in tech transfer for these…
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Drug Quality Key to Innovation and Access
Industry and FDA will face challenges as they continue to implement drug supply chain monitoring programs, as required by the Drug Supply Chain Security Act (DSCSA) of 2013. An immediate task is to pr…
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Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Other early efforts were driven by a desire for cost reduction and improving the reliability of raw-material supply. Some of these efforts resulted in the substitution of complex tissue digests or ext…
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Biopharma Advances Demand Specialized Expertise
…ontamination, glass particulates, and foreign materials that lead to necessary market action causing supply issues.
Lorimer (Patheon Biologics): The greatest regulatory change in recent times is t…
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Vaccine Development and Production Challenges Manufacturers
Back in the US, two vaccines to protect against meningitis B have been approved by FDA, using expedited processes to ensure a licensed supply in case of another serious meningococcal disease outbreak,…
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Trends in Single-use Bioreactors
Galliher (Cytiva): Some barriers to single-use bioreactor adoption include:
• A much stronger dependence upon the vendor’s supply chain and the need to ensure that the vendor has as robust a sup…
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Biopharma Manufacturers Respond to Ebola Crisis
NewLink has sufficient supply for initial trials and is working with several contract manufacturers to scale up production.
In addition, Johnson & Johnson (J&J) is accelerating testing of an Ebola…
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FDA Seeks Metrics to Define Drug Quality
FDA is seeking new strategies to spur compliance with GMPs and to limit drug production errors that lead to supply problems, Woodcock explained at a July 10, 2013 seminar on “Understanding cGMPs” spon…