Search results for " process"
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Antibody Production in Microbial Hosts
Cell-culture process parameters affecting the glycosylation level of mAbs also need to be controlled to ensure consistent product quality (6). Selection of a stable antibody-producing clone is also a …
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FDA Releases Draft Guidance on Emerging Manufacturing Technology
The guidance discusses product quality, affirming that stable manufacturing processes ensure “acceptable and reproducible product quality.”
FDA admits there may be limitations to manufacturing inn…
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Antibody Fragments and Their Purification by Protein L Affinity Chromatography
In the case of recombinant full-length antibodies with suitable Fc regions, two or three column purification processes centered around Protein A affinity chromatography have proven to be fast, efficie…
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A Q&A With Prof. Alois Jungbauer: The Role of HIC in Biotech
I think this could be very important in the era of QbD and increased process understanding.
Read more Q&As with Industry Leaders Here
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What’s In a Name? For Biosimilars, A Lot
BioPharm International spoke to USP to find out a bit more about how the naming process for a drug occurs and who truly will have the final say when it comes to biosimilar nomenclature.
Naming for…
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Modern Manufacturing Systems Key to FDA Quality Initiative
A risk-ranking process for all locations will drive CDER inspection planning and site visits, with an eye to focusing on more serious problems. Metrics may inform inspection frequency, help FDA set in…
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Relationship Building at Top of Mind for Clients
Add to this the uncertain nature of process development and problems that invariably arise, and it is easy to see how scheduling can be challenging.
That doesn’t make scheduling any less important,…
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A Q&A With Phil Lester, co-organizer of the HTPD Conference
Can you tell us about the genesis of the conference?
Phil: Back in 2008 high throughput process development was an emerging technology and I could see it was going to be a game-changer. I thought …
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Biopharma Outsourcing Activities Update
So essentially, this year BioPlan found something of a bimodal trend, more complex process outsourcing and greater outsourcing volume of basic bioprocessing, such as fill-finish, and other activities.…
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A Platform Approach for the Purification of Domain Antibodies (Dabs)
This Application note describes a three-step purification process of a domain antibody (Dab) expressed in the periplasm of E. coli. First, a capture step using Capto™ L was used to reduce E. coli host…