Search results for " pilot"
Article
Assessing leachables risk over a complete single-use, mAb process
In an article, process equipment-related leachables are mapped over a complete single-use mAb process at pilot scale.
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Article
Simplify-bioreactor scale up and scale down: applications and tools
Scaling the physical environment in a bioreactor is a frequent task in each product development project. A well-designed scaling strategy, workflows, and easy-to-use tools will facil…
Article
Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
During this time, he's developed scalable synthesis and utilized process analytical technology to monitor reactions and crystallization from the laboratory to the pilot plant. In 2016, he moved to the…
Article
Cell-Culture Advances Test Bioreactor Performance Models
Challener
Modeling and simulation are recognized to provide assistance in predicting bioreactor performance, both for initial laboratory runs and when scaling to the pilot plant and commercial ma…
Article
The Outlook for CMO Outsourcing in 2019
…ot fully permitted in China; just a few select companies currently participate in government-run CMO pilot programs (3). Once China turns on its domestic bioprocessing industry, China may become a ma…
Article
Scaling Up Novel Therapies
The obvious target for scale-down models that accurately mimic larger scale equipment is in cases where pilot or industrial runs are most expensive (e.g., chromatography process steps or cell culture)…
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Start With the End in Mind: GMP Tech Transfer
How can you be one step ahead in process development and prepare for future GMP work?
Hear what tech transfer experts have to say about this important issue in this blog. And, learn how to apply …
Poster
Scale-up and process economy calculations of a dAb purification process using ready-to-use products
Purification of a domain antibody (dAb) in a chromatography capture step was successfully scaled from laboratory to pilot scale using ready-to-use equipment and ready-made buffers. The scaled-up pro…
Article
Process Chromatography Selection for Downstream Processing Applications
Robust column packing and long-term bed stability may be a challenge for some chromatography media, particularly at pilot and large scale. The column packing depends on the media characteristics, the …
Article
USP Stresses Pharmacopeial Standards at CPhI China
As part of USP’s commitment to the growth of the Chinese pharmaceutical industry, the Convention has built training facilities in the Shanghai Pilot Free Trade Zone. “We will strengthen our collaborat…