Search results for "downstream"
Article
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…
Article
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 …
Article
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…
Poster
Purification platform challenges and strategies for handling of "tricky" MAbs
In the work presented here, capture using high-capacity protein A medium (resin) was followed by polishing using a novel cation exchange chromatography medium.
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…
Article
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…
Article
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…
Article
The Development and Application of a Monoclonal Antibody Purification Platform
The goal is to manufacture early-phase material without having to perform downstream development, and the current process as outlined in Figure 1 is capable of meeting that goal. However, further incr…
Article
Flexibility in Biopharmaceutical Manufacturing
Maintaining flexibility in biopharmaceutical manufacturing can deliver positive results.
By: Simon Chalk
BioPharm International
There is a high degree of consensus in the biomanuf…