Search results for " CIP"
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
The riboflavin testing used for spray device qualification in CIP systems also helps in identifying areas that must be sampled due to limited coverage.
Risk-based surface sampling locations an…
Article
Hybrid Bioprocessing: A Q&A with Andrew Sinclair
Bioreactors tend to be very complex when incorporating CIP and SIP, so the SU bioreactors address the complexity of CIP and SIP and remove the supporting infrastructure requirements. By limiting to 2,…
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Re-use of Protein A Resin: Fouling and Economics
With respect to the factors that impact the lifetime of Protein A resin, the most significant factor is the selection of CIP solution. The impact of the CIP buffer is both with respect to the effectiv…
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Automating Bioprocesses
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Emerson: The complexity of automation is less for SUS because fixed, stainless-steel tanks require CIP/SIP, which increases the complexity of piping and instrumentation. In fact, 60–80% of instrume…
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Comparing Protein A Resins for Monoclonal Antibody Purification
…f antibodies, its sensitivity to alkaline conditions prevents the use of rigorous and cost-effective CIP and sanitization protocols based on NaOH.
Compared to conventional Protein A resins, one o…
Article
Alkaline stability of Fc and VH3 binding in protein A resins
We evaluated NaOH incubation and the effect of performed CIP cycles for two established protein A resins on the market.
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Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
“Staggering the CIP/SIP of equipment and transfer lines can also accelerate changeovers by ensuring that the critical equipment can be isolated for priority cleaning to facilitate the start of the nex…
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Single-Use Technologies Prove Effective for Viral Vector Process Development
The benefits of single-use technologies for upstream viral-vector processes clearly outweigh their disadvantages.
Cynthia A. Challener
Upstream viral-vector processes can have sig…
Article
Efficient Sodium Hydroxide Sanitization with a Novel Procedure of AxiChrom™ Columns Packed with Chromatography Resin
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Sodium hydroxide (NaOH) cleaning-in-place is the widely accepted method of sanitization employed by biopharmaceutical manufacturers to avoid the excessive costs and delays of a…
Resource
Protein A Fiber Chromatography from Research to Scale-up and Manufacturing of Monoclonal Antibodies
The new Protein A fiber chromatography format allows for quick purification of many samples because of its short cycle times. This makes the pre-packed, small-scale Protein A fiber unit a versatile …