Search results for " facility" in Articles / App Notes
Article
Automation Trend in Fill/Finish Reduces Contamination Risk
Fill/finish operations for biologics is largely automated as “the number of manual fill operations is diminishing,” says Iain MacGilp, PhD, head of manufacturing at the Glasgow facility of AMRI, a con…
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Good Manufacturing Practices: Challenges with Compliance
Muzzin (Emergent): One industry challenge is the need to continuously strike a balance between providing continual supply of products to the market with the approved facility and/or equipment while al…
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The Challenge of Disruptive Technologies in Bioprocessing
When a business already owns a production facility, cost reduction is usually the smallest of the candidate advantages,” Jagschies says.
Securing continued supply from that facility to all pati…
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Roadmap Leads to Innovative Biomanufacturing Strategies
To some degree, the need for flexibility in facility design has already been realized. Future facilities will need to accommodate an increasingly wider array of product types to justify the significan…
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Bioburden Control in the Biopharmaceutical Industry
The basic standards for establishing a facility for manufacturing, processing, and packaging biopharmaceutical products should, therefore, ensure that these three criteria are met …
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Contract Manufacturing Through the Years
Facilities were usually sold to CDMOs, many of which were formed for the specific facility being sold, at a nominal price and with contracts for legacy products. That enabled the bio/pharmaceutical co…
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
Taken together, upstream and downstream process innovations can be packaged into an automated, continuous, small-footprint antibody production facility that can fit into a single cabinet in approximat…
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Perfusion in the 21st Century
Increased productivity can allow biosimilar manufacturers to achieve flexibility with a smaller facility footprint, and enable them to adapt operations for multiple products (1).
Perfusion was fir…
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Vaccine Development Faces Urgency and Challenges
For example, the transfer of production of a long-used vaccine adjuvant to a new facility at GSK’s Marburg, Germany, production site took five years and involved 15,000 pages of nearly 300 documents, …
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Modern Manufacturing Systems Key to FDA Quality Initiative
Reducing shortages
More information on the ability of a production facility to consistently produce high quality products also can help FDA identify potential problems early on that could cause man…