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).
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.
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.
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.
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.
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.
What are the benefits of introducing multimodal ion exchange chromatography as a guard column and could they include a significant increase in mAb purity? This article presents a study in which two protein A affinity chromatography resins were compared to see whether the introduction of a guard column could improve mAb purity and to discover which of the protein A resins produced the best results.
In short, an efficient protein A resin is one that will not only help you purify your monoclonal antibody (mAb), but also enable you to achieve good process economy. But what are the characteristics of such a resin and how can it improve your processes? Here are the characteristics to look for when selecting a resin for your mAb purification.