The Purification Insights Blog

The Bio-Works Team

The Bio-Works Team
The Bio-Works staff are seasoned and enthusiastic (yes, even a bit nerdy) experts in purification resins, methods and strategies with many years of experience of the ins and outs of this field. We love our job and we’d love to help you do yours by sharing some good solid facts, principles and best practice. In short – “purification made simple”.
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Recent Posts

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

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

Are mAbs the ultimate targeted therapy?

Posted by The Bio-Works Team on Sep 25, 2019 2:26:00 PM

Since the 1980’s, monoclonal antibodies (mAbs) have revolutionized healthcare and continue to do so. A short history of mAb approvals shows their increasing sophistication and targeting of disease mechanisms – even down to purifying them for medicinal use.

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Topics: mAbs, WorkBeads affimAb

QuickTip #2: choosing IEX resin

Posted by The Bio-Works Team on Sep 12, 2019 11:55:00 AM

Recovery of the biological activity of your target substance is a priority, and it’s important to check for its pH and ionic strength stability values...

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Topics: Quick Tips, Tips and Tricks, Ion exchange chromatography, IEX

CHO cells in fed-batch bioreactors dominate mAb upstream processes

Posted by The Bio-Works Team on Sep 9, 2019 2:58:08 PM

Choosing a mammalian cell line or other type of host is as critical a question as any other in the complex world of monoclonal antibody (mAb) manufacture. We take a look at the present status, with fed batch Chinese Hamster Ovary (CHO) cell culture in a dominant position, and reflect on the ever-present need to keep upstream and downstream development teams talking to each other.

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Topics: mAbs

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

Recent (May 2019) figures for illnesses with approved monoclonal antibody therapies

Posted by The Bio-Works Team on Jun 26, 2019 9:30:46 AM

As our understanding of diseases at the molecular level increases, so does the potential for monoclonal antibody (mAb) - related therapies. Platform approaches to mAb production, including purification, are a key to their successful manufacture and, in particular, streamline process development.

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Topics: mAbs, Biologics, Biopharmaceuticals

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

mAb Purification – an overview of the essentials

Posted by The Bio-Works Team on Apr 24, 2019 11:26:15 AM

Five of the top ten best selling drugs in 2017 were mAbs and the global mAbs market is expected to reach USD 219 billion by the end of 2023. The mAbs entering the clinic today are highly engineered and are presenting new challenges in purification. When patients are treated repeatedly with high doses and over long periods, the accumulative effects of impurities can be substantial, so the purity requirements of mAb drugs are very stringent. 

We've summarized some of the essentials of mAb purification to give you a quick and broad overview of this fast-growing and exciting field. 

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Topics: mAbs, Protein A

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