Search results for " production" in Articles / App Notes
Article
Scale-Up Model of a mAb Process from Microbioreactor to XDR-1000
A theoretical scale-up study was performed on a mAb process based on physical characterizations done on the Xcellerex XDR platform, from micro reactors up to large production-sized reactors. All inves…
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Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
Single-Use Technologies Are Still Growing—But Not Without Challenges
Single-use technology is said to offer a plethora of benefits in the production of biopharmaceuticals and biosimilars, includin…
Article
What's in Your SOP?
What’s in Your SOP?
SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
…
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Roadmap Leads to Innovative Biomanufacturing Strategies
As new therapeutic technologies continue to emerge, the required production technologies will need to be included. To some degree, the need for flexibility in facility design has already been realized…
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Development and Future of Protein A Chromatography Technology: Q&A with Jonathan Royce, Business Leader Chromatography Resins, Cytiva
This week Process Development Forum talks about Protein A with Jonathan Royce, business leader for Cytiva chromatography resins.
mAb purification platforms are very well established, and …
Article
Improvements in Protein A Chromatography
This effort is often justifiable only after mAb licensure and production requirements are clear.
A more diversified pipeline of molecules can now be seen. Do you expect a similar approach with a…
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Technical and Process Economical Aspects of Using Capto™ Q and ReadyToProcess™Adsorber Q in mAb Polishing
Increasing product titers in upstream cell culture processes pose challenges to downstream purification processes. For efficient operations, downstream purification needs to be able to handle high p…
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Using Single-Use Technologies in Downstream Processing
The use of single-use systems in downstream processing offers benefits in filtration and sampling and may reduce the risk of contamination.
Jul 01, 2015
By Susan Haigney
BioPharm Inter…
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Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
Once collected, we primarily separate risks based on either potential quality/patient impact or production impact (only). Depending on the risk priority numbers, higher-scoring risks are mitigated and…
Article
Finding Opportunities in Brazil
Brazil’s trade is driven by its natural resources, and agricultural and manufacturing production and foreign investment have recently been attracted by scientific and technological development, rising…