The Purification Insights Blog

Join the effort to make chromatography sustainable

Posted by The Bio-Works Team on Nov 8, 2019 9:15:00 AM

The environmental impact of pharmaceutical R&D and production is considerable. Although the industry is rather conservative and also constrained by regulatory guidelines, there is increasing interest in the implementation of sustainable practices that not only improve corporate social responsibility (CSR) performance but also reduce costs and increase efficiency. This effort is embodied in the concept of Green Chemistry and includes reducing the use of toxic solvents in production and purification, which is a considerable problem. Solutions include recycling and the use of upstream protective columns that remove bioburden to increase the life-cycle of columns used downstream, or even make certain solvent-consuming steps redundant altogether.

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Topics: guard column, Biologics, Biopharmaceuticals, Cleaning in place, Resin fouling, RPC, orthogonal

QuickTip #1: cleaning IEX columns

Posted by The Bio-Works Team on Sep 5, 2019 3:23:49 PM

When an IEX resin has been used for some time, impurities may build up in the column causing loss of resolution or increase in back pressure (shown on the pressure monitor or seen by gap formation on the top of the column)...

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Topics: Quick Tips, Tips and Tricks, Ion exchange chromatography, IEX, Cleaning in place

Improved peptide purification promises to boost process efficiency in the race to affordable insulin in China

Posted by The Bio-Works Team on May 29, 2019 9:57:45 AM

The global diabetes pandemic has created a massive demand for insulin, especially in China, which is expected to soon have half the world’s diabetes patients. Meeting this demand means developing extremely efficient production methods that can supply affordable insulin with high purity. A promising approach is to add an orthogonal step upstream the main reverse-phase chromatography (RPC) peptide purification to increase purity and also guard the expensive high-performance RPC columns from bioburden and stringent cleaning-in-place procedures.

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Topics: Biopharmaceuticals, Peptides, Peptide drugs, Cleaning in place, Resin fouling, RPC

How to improve process efficiency and economy in peptide production

Posted by The Bio-Works Team on May 16, 2019 11:29:13 AM

The purity requirements for therapeutic peptides are very stringent, but synthesis generates a crude peptide mixture containing failed sequences and chemical variants, while recombinant peptides have a considerable bioburden from the host cell. These crude feeds can foul the reverse phase chromatography (RPC) columns commonly used in peptide purification. Introducing an orthogonal purification step upstream significantly reduces the burden on the expensive high performance RPC column, increases the peptide yield and purity, and also prolongs column lifetime.

 

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Topics: Ion exchange chromatography, guard column, Peptides, Peptide drugs, Cleaning in place, Bioburden, RPC

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