Search results for " capacity"
Article
Tools and Processes for Mature and Emerging Therapies
…nufacturing organizations debated the challenges associated with meeting bioprocessing manufacturing capacity demands for traditional biologic-based drugs, such as monoclonal antibodies.
Topics d…
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Roadmap Leads to Innovative Biomanufacturing Strategies
Evolving capacity needs
BioPharm: How would the Biomanufacturing Technology Roadmap remain relevant as the manufacturing technology and capacity needs in the biopharmaceuticals industry continue t…
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Reducing Cross-Contamination Risks in Process Chromatography
“It is quite straightforward to add an additional disposable processing line to increase capacity. Furthermore, the manufacturing facility can be utilized for another product after the target yearly s…
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Development and Future of Protein A Chromatography Technology: Q&A with Jonathan Royce, Business Leader Chromatography Resins, Cytiva
In the last decade, significant development has also been made in the area of Protein A, both in term of binding capacity and stability, as discussed in a previous Q&A session. What do you feel are th…
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Improvements in Protein A Chromatography
…lacing protein A chromatography step with alternative purification methods due to the high cost, low capacity and limited robustness of Protein A. However since 1978, the capacity and productivity of…
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Fluid Handling in Biopharma Facilities
On the other hand, readdressing fluid handling capacity and functionality within an existing facility can yield substantial operational and cost benefits. Here as well, conceptual work pertaining to p…
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Biomanufacturing Outsourcing Globalization Continues
…ary data from BioPlan Associates’ 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (1).
As part of the survey, biotherapeutic developers are asked to estim…
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Application of Quality by Design to Viral Safety
…w the level of viral contaminants in process load materials can be compared with the viral reduction capacity of the manufacturing process so that an assessment of the level of viruses in a dose of p…
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FDA Seeks Metrics to Define Drug Quality
Boosting capacity
While manufacturers see value in quality metrics, they are less enthusiastic about proposals that FDA encourage redundant manufacturing sites as a strategy for preventing shortage…
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Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
Key considerations such as LEAN, multipurpose and flexibility was designed and built in to the facility from start, ensuring high capacity, microbial control and tracing of all filled vials. During th…