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.
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...
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.
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)...
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.
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.
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.
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.
The healthcare sector and developers of new pharmaceuticals are facing increasing challenges, along with pressure to lower costs. At the same time pharmaceutical development is undergoing a revolution with the use of biological substances as therapeutics.
We took a general look at some aspects of the biopharmaceutical industry today, the particular cost challenges facing chromatographic purification of biomolecules and some means of increasing chromatography efficiency that are close to hand.
The market for monoclonal antibodies (mAbs) is constantly growing as mAb therapies are generally considered to be both safe and effective treatments for difficult diseases like cancer and rheumatoid arthritis. The growing global demand, as well as increasing competition, puts pressure on manufacturers of mAb products to improve their operations. There is a need for more efficient resins, as well as for innovative strategies to continuously improve purification processes. Bio-Works resins provide many benefits that help you improve your mAb purification process while at the same time achieving cost efficiency in your production.