Search results for " supply"
Article
A Look Ahead at BioPharma Manufacturing and Regulation
…ectious diseases and terrorism; enhancing safety and health through informatics; protecting the food supply; modernizing safety testing; meeting challenges for regulating tobacco; and setting a colla…
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Report from the 12th Plasma Product Biotechnology Forum
Due to the circumstances, Biopharma has had to take on many non-standard operations such as construction of bomb shelters for workers and plasma donors and ensuring uninterrupted supply of electricity…
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Track-and-Trace Progress Benefits Supply-Chain Security Efforts
Since the COVID-19 pandemic struck, there has been little news of serialization breakthroughs, as manufacturers and their supply partners have focused on getting new therapeutics and vaccines to patie…
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Single-Use Technologies Prove Effective for Viral Vector Process Development
They are also designed to increase cell-culture density while maintaining adequate gas exchange and supply of nutrients and preventing accumulation of cell culture byproducts, according to Tan.
Fo…
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A Plastic Pipeline for Commercial Bioprocessing?
Louis, MO, to expand the company’s biologic drug substance capabilities for clinical and commercial supply. The expansion will double manufacturing capacity at the site and will feature a mix of Therm…
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Managing Biomanufacturing Capacity Expectations
When the date for market launch is set, these companies will often look for additional CMOs to back up their supply chain.”
Excess capacity
As mentioned, it is common to overestimate or undere…
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Platform Approach Speeds Process Development
Figure 1: Cell-culture process development concept for Phase I supply including media screening and optimization as well as bioreactor screening optimization modules. For the time scale, one box corre…
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Raw Material Variability
Raw material supply chains are complex and multi-tiered. Risk management tools are expected and widely used for impact assessments and to focus on the most important issues.
The industry is now …
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Best Practices in Adopting Single-Use Systems
Consistency and availability of materials of construction directly affect the quality and supply of single-use products. End-users should expect availability of the same or equivalent materials of con…
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The Development and Application of a Monoclonal Antibody Purification Platform
A purification scheme to maximize the efficiency of the purification process and product purity while minimizing the development time for early-phase therapeutic antibodies.
The following ar…