The Purification Insights Blog

QuickTip #7: Improve purity of viruses and vaccines

Posted by The Bio-Works Team on Jan 15, 2020 1:01:24 PM

Changing from purification products based on synthetic polymers to agarose-based chromatography will increase the purity of the target virus.

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Topics: Quick Tips, Tips and Tricks, SEC, Viruses, Vaccines

Enhanced Capture Process - a presentation

Posted by The Bio-Works Team on Jan 9, 2020 9:11:51 AM

Just before the Christmas break, Lars, Haneskog, Bio-Works R&D Director, presented a new and proven strategy for downstream processing at the New Horizons in Biologics and Bioprocessing conference. It was met with great interest and several enquiries and, for those that missed it, we asked Dr. Haneskog to give us a brief summary of what was discussed.

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Topics: Protein A, Biologics, Biopharmaceuticals, WorkBeads TREN, Cleaning in place, Bioburden, Resin fouling, orthogonal, WorkBeads 40S

How reversing downstream bioprocess steps can make all the difference

Posted by The Bio-Works Team on Dec 16, 2019 11:09:56 AM

Improving downstream bioprocess economy depends on fine-tuning an enormous range of parameters, from culture and harvesting to purification and final polishing. Success depends on the ability to troubleshoot difficulties and identify novel approaches that will boost process efficiency in a cost-effective manner. This is particularly true when high-value chromatography columns are used in the process. Bioburden and cleaning-in-place procedures can reduce column lifetime and capacity, and threaten product quality and yield. An alternative approach that protects these valuable columns is to reverse the first two steps to remove the potentially damaging components of a feedstock before proceeding with highly selective capture followed by polishing. We call this ECP... 

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Topics: Protein A, Biologics, Biopharmaceuticals, WorkBeads TREN, Cleaning in place, Resin fouling, RPC, orthogonal, WorkBeads 40S

QuickTip #6: Use true buffers

Posted by The Bio-Works Team on Dec 4, 2019 9:15:00 AM

A critical and fundamental factor in both analytical and preparative chromatography is the use of true buffers. In other words, mobile phases with buffering capacity. For example, in peptide purification, there are concentrated bands of various components of the sample, including the target peptide, moving through the column and you need to have control over their tendency to dissociate...

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Topics: Quick Tips, Tips and Tricks, Protein purification, Peptides, Buffers

QuickTip #5: Filter everything

Posted by The Bio-Works Team on Nov 26, 2019 11:45:00 AM

Filtering is crucial in order to protect the packed column from all solid particles in feeds or eluents. Clogging of the column will increase back-pressure and disturb the feed loading zone causing reduced resolution and it is a common problem...

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Topics: Quick Tips, Tips and Tricks, Ion exchange chromatography, IEX, Resin fouling, IMAC, Filter, SEC

Ten things you must know when producing synthetic therapeutic peptides

Posted by The Bio-Works Team on Nov 18, 2019 9:40:39 AM

Peptide therapeutic agents are enjoying increasing success but they are challenging to produce and, not least, to purify. Purity requirements are, in fact, approaching those for small molecules. Synthesis generates a crude mixture containing failed sequences and chemical variants. 

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Topics: Tips and Tricks, Biologics, Biopharmaceuticals, Peptides, Peptide drugs, orthogonal, synthetic peptides

QuickTip #4: yield of His-tagged proteins

Posted by The Bio-Works Team on Nov 14, 2019 9:15:00 AM

Immobilized Metal Ion Affinity Chromatography (IMAC) is used for purification of His-tagged proteins. Ni-NTA based resins are the most commonly used as the Ni2+ ion is considered to have the strongest affinity to histidine-tagged proteins but stringent requirements on the yield of target protein can make it well worth the extra effort of trying another metal ion to optimize the purification process...

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Topics: Quick Tips, Tips and Tricks, Protein purification, His-tagged, IMAC

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 #3: optimizing mAb purification

Posted by The Bio-Works Team on Oct 14, 2019 1:38:24 PM

Designing an optimized purification process means maximizing yield and purity, and at the same time controlling costs. So, you remove a lot of bulk impurities during the first steps, and focus on high yield steps at the end, when every gram is precious. If you’re purifying mAbs, it would also be good to remove impurities before affinity chromatography to protect the protein A column and reduce the need for cleaning in place (CIP).

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Topics: Quick Tips, mAbs, Tips and Tricks, Ion exchange chromatography, guard column, Multimodal, Bioburden

Affordable and safe biosimilars for affordable healthcare

Posted by The Bio-Works Team on Oct 2, 2019 3:19:08 PM

When it comes to many serious and challenging diseases, healthcare has reached a point of unsustainability, due to drug costs. For example, sustained therapy for an autoimmune disease or cancer, involving large amounts of monoclonal antibodies (mAbs), might not be a viable option for simple economic reasons. As a consequence, healthcare authorities want to reduce the cost of drugs by encouraging the development of biosimilars. When biological drugs are off-patent they can be copied – which is cheaper than developing the novel drug, but still challenging because of the need to demonstrate the same efficacy and safety. Drug purification, a key to successful manufacture of biologicals, must also adapt by exploiting products and technologies that lower the overall cost of production.

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Topics: mAbs, Biologics, Biopharmaceuticals, Biosimilars

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