Search results for "downstream" in Articles / App Notes
Article
Sources of Bioburden You Might Have Missed
What better place for a bacterial contamination to grow than in a well-aerated, nutrient-loaded cell culture medium? Downstream operations also have their share of risk. The open handling introduces m…
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HTPD: Optimizing a mAb Chromatography Polishing Step
Development of robust purification processes requires significant time and resources. In addition, steadily increasing demands from regulatory authorities for better understanding and control of man…
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High-Throughput Process Development Handbook
Time-to-clinic and time-to-market are two key factors for successful biopharmaceutical development. Efficient development of the manufacturing process is a crucial component of the overall project…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
…ng (bulk harvest, drug substance, drug product)
Viral clearance affored by downstream purification.
A written emergency (contamination) response plan is an important pa…
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Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
A typical batch at 2 g/L with a 70% overall yield in downstream processing and a 95% production success rate will therefore yield 138 kg/yr in total. The final yield here is determined by the product …
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Automated harvesting and 2-step purification of unclarified mammalian cell-culture broths containing antibodies
The results showed that the overall performances of the preparative automated system were higher compared to the conventional downstream process including manual harvesting and purification. The mean …
Article
Selecting a Comprehensive Bioburden Reduction Plan
Virus nanofiltration is typically implemented downstream for removal of adventitious viruses from raw materials or endogenous retroviruses expressed by cells.
Methods and Processes
BioPharm: I…
Article
Re-use of Protein A Resin: Fouling and Economics
In a typical platform process for production of mAb therapeutics, approximately 80% of the total process costs are for the steps following fermentation, with up to 60% of the downstream costs coming f…
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Optimizing Resin Performance with Disposable Chromatography Solutions
They are designed to improve downstream processing performance, ensure consistency of product, reduce cost, and reduce time between batch runs. Total suite, labor, and material costs decrease dramatic…
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Bioprocessing Advances in Vaccine Manufacture
These improvements are much needed, as advances in upstream manufacturing (everything through product formation in the bioreactor) causing capacity constraints and problems, because later downstream p…