Scale Up

Oct 01, 2007
BioPharm International
By BioPharm International Editors
It became a strategic imperative to find a better, more efficient way to manufacture our products. To continue with the status quo was untenable.
Oct 01, 2007
BioPharm International
By BioPharm International Editors
It is commonly believed that technologies in the next 10–15 years will enable sequencing an individualized human genome for less than $1,000. With innovations like these, the twenty-first century will certainly belong to biotechnology. From an industrial standpoint, the discovery of therapeutic molecules and the development of cell lines and processes to produce these molecules will be of paramount importance. This article describes various approaches that have been prevalent in the industry or are likely to be used in the future for generating cell lines with desirable traits and developing high titer cell culture processes.
Oct 01, 2007
BioPharm International
Low-pressure process chromatography could not have developed without immense efforts to resolve scale-up issues in both column design and matrix stability.
Sep 13, 2007
BioPharm International
By BioPharm International Editors
Small biotechnology companies often need guidance during the development of new therapies—particularly when it comes to manufacturing.
Sep 01, 2007
BioPharm International
By BioPharm International Editors
From the earliest days of the biotechnology industry, companies have grappled with the complexities of making innovative biopharmaceuticals on a large scale. Success in manufacturing begins with process science, since biotech production requires perfection in maintaining living organisms in a sterile environment under controlled physiological conditions. But unless companies can solve the challenge of planning for and managing manufacturing capacity, they will not be able to achieve the full potential of promising biotech products.
Sep 01, 2007
BioPharm International
In analyzing the industry's current challenges, let's be careful before extrapolating about what they mean.
Feb 02, 2007
BioPharm International
These articles encapsulate the past, present, and possible future of process-scale chromatography in biopharmaceutical production.
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.
Sep 02, 2006
BioPharm International
Development reports document process development and support the design of validation experiments, yet in many firms training is not provided nor are expectations established. This article describes how project managers can help scientists master the art of report-writing.
Aug 01, 2006
BioPharm International
Capital investments in production plants represent a significant portion of the cost of new recombinant drugs
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