Search results for " production"
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…
Article
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…
Poster
Opportunities, Challenges, and Economic Drivers for Start-to-Finish Continuous Biomanufacturing
Continuous unit operations have been used successfully in manufacturing of several approved products with a collective revenue of $25 billion annually. Many large biopharmaceutical organizations are…
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.
…
Article
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…
Article
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 …
Poster
Fast Trak Services: a collaborative project to accelerate downstream biosimilar process development
To improve the availability, price and access of medicines, many countries are implementing strategies to establish their own production capacity.
To support this development, mAbxience, a Sp…
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…
Article
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…
Poster
Scale-up of CHO fed-batch cultures in HyClone™ ActiPro™ medium supplemented with Cell Boost™ 7a and 7b
Results from shake flask cultures show high viable cell densities and protein production. In addition, scalability of the culture process was demonstrated in 2 and 50 L bioreactor cultures. Cell densi…