Scale Up & Tech Transfer

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.
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.
Oct 01, 2006
BioPharm International
By BioPharm International Editors
We often assume we know what success looks like for our partner, but we never ask them, or take the time to write it down.
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.
Sep 02, 2006
BioPharm International
By BioPharm International Editors
Established, fully validated methodology and SOPs are required prior to initiation of any training activities.
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