Search results for " capacity"
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FDA Framework Spurs Advanced Therapies
Lonza anticipates that customers will require the ability to increase scale and capacity efficiently to keep pace with clinical development needs, which in some cases may conflict with the increased s…
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Technologies and Practices Must Evolve to Meet Demand
More than 45% of the respondents reported an increase in manufacturing capacity in 2014; 9.6% said their company increased outsourced manufacturing. Less than 2% reported a decrease in in-house manufa…
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Outsourcing Trends in Biopharmaceutical Manufacturing
According to BioPlan Associates’ 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (1), outsourcing and off-shoring have migrated into much more high-value areas…
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Evolution of the Monoclonal Antibody Purification Platform
Load capacity (>1500 g/L) may be achievable with > 95% product recovery and robust process performance.
Monoclonal antibodies expressed in yeast
While mammalian cells (e.g., such …
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Strategizing for Rapid Changeovers in Biologics Manufacturing
Vaccine developers also need to ensure flexibility with respect to the expected required manufacturing capacity, according to Stoll. “One approach is to work with contract development and manufacturin…
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Gene Therapies Push Viral Vector Production
The solution to increasing viral vector capacity involves both structural and technical issues. Vicaire states that a combination of structural evolution on the CDMO side and development of new techni…
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Flexible Facilities for Viral Vector Manufacturing
The company has been busy expanding, and, in December 2019, it opened a 50,000-ft2 facility in Lexington, MA to provide capacity for the contract development and manufacturing organization (CDMO) to s…
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Supply Chain Challenges for Single-Use Systems
It is important that suppliers proactively identify the potential risks and minimize the probability and impact of supply disruptions through effective demand planning/forecasting, capacity planning, …
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Downstream Processing for Cell-Based Therapies
Equally, DSP techniques adapted from protein production for CGTs have the capacity to handle the scales required for allogeneic therapies but are hindered by the lack of specificity and sensitivity to…
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Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
To define the necessary capacity of the facility, the primary question is how many batches per product per year are needed? However, this number has not always been defined when the facility design st…