Downstream Processing

Nov 09, 2006
By BioPharm International Editors
In recent years, disposable membrane chromatography has gained acceptance as a robust device for large-scale processing.
Nov 09, 2006
The many benefits of disposable technologies, such as significant savings in time, labor and capital, as well as ease of scalability and flexibility, have led to the growing trend of adopting disposable technologies in bioprocess manufacturing processes.
Nov 02, 2006
BioPharm International
By BioPharm International Editors
Filtration systems exemplify disposable technologies that can be presterilized.
Nov 02, 2006
BioPharm International
Biopharmaceutical processes typically require a significant investment in equipment—often a substantial obstacle for start-up companies. The risk of drug development failure is often high, further limiting access to the required capital. Flexibility and lower capital outlays are required not only by start-up companies, but also by research organizations with multiple product lines and by companies requiring quick capacity increases. Disposable technologies offer the highest potential for these companies to meet their business requirements. With lower capital requirements and increased flexibility, disposables are an important part of these companies' risk management strategy.
Nov 01, 2006
BioPharm International
This article shows how Probabilistic Tolerance Intervals of the form, "We are 99% confident that 99% of the measurements will fall within the calculated tolerance limits" can be used to set acceptance limits using production data that are approximately Normally distributed. If the production measurements are concentrations of residual compounds that are present in very low concentrations, it may be appropriate to set acceptance limits by fitting a Poisson or an Exponential Distribution.
Nov 01, 2006
BioPharm International
By BioPharm International Editors
If a company wants to reduce costs, it should consider outsourcing some manufacturing and analytical testing to low-cost sites.
Nov 01, 2006
BioPharm International
The number of biotechnology-based human therapeutic products in the late-stage pipeline, and the average cost to commercialize a biotech product, have steadily increased. This has required biotech companies to use economic analysis as a tool during process development and for making decisions about process design. Process development efforts now aim to create processes that are economical, as well as optimal and robust.
Nov 01, 2006
BioPharm International
By BioPharm International Editors
Increased resin stability can extend the number of cleaning cycles that can be performed in situ.
Oct 01, 2006
BioPharm International
By BioPharm International Editors
Formulations for pulmonary inhalation comprise spherical, porous particles that are 1–3 microns in diameter.
Oct 01, 2006
BioPharm International
It is important to ensure that flow decay during processing is comparable to that observed during retention studies.
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