Without careful consideration of what are the most important features you need from a CMO and preparing for what the CMO needs from you, the result can be a mismatch.
For many decades, it has been found that the most effective method for determining pyrogens in pharmaceutical samples, regardless of the form of the active substance, is the LAL test.
Protein purification at the lab scale bridges the gap between small-scale exploratory protein purification and high-throughput operations, such as industrial- scale manufacturing. At the larger end of the scale, advances in upstream processing such as improved fermentation capacities have led to increased amounts of crude sample available for input. Despite this meaning higher potential yields of target proteins, it also poses an enormous challenge for timely and cost effective sample processing further downstream. This challenge is made even more difficult as scale increases due to higher amounts of impurities — a result of prolonged fermentation times and higher cell densities in large-scale cell cultures.
Philip Lyman, PhD – Director of Process Simulation at CRB – discusses how a process model, at the right detail level and properly validated, can be an invaluable tool to compare alternatives and justify cost for manufacturing and manufacturing-related processes.
When a clinical trial progresses, the formulation itself and the dosage form may change. As a result, sponsors may also want to consider the desirable commercial format in later stage clinical studies.
This articles provides some fundamental tips and tricks to preparative chromatography that will yield a pure sample preparation that will advance protein characterization studies.
The ultimate goal of a template is to help investigators create high quality protocols that are consistent, well organized and contain all pertinent information needed to be properly reviewed.
To ensure the package is error free, progressive companies now use automated proofreading solutions throughout the design and printing of the package and label.
The impurities of a therapeutic protein might be similar molecules obtained as part of the protein biosynthesis, or might come from the cellular substrate used in its production or from the production process itself.
Any company pursuing a drug delivery system that involves a complex formulation must be prepared for the requirements around this type of drug development to achieve successful scale-up.
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