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Kalorama: ZMapp Highlights Need For Faster Biopharmaceutical Production
Date:10/20/2014

NEW YORK, Oct. 20, 2014 /PRNewswire/ -- Mapp Biopharmaceutical's valiant effort to produce more of their experimental ZMapp™ antibody therapeutic to fight the Ebola outbreak will make the public aware of how difficult and time-consuming the production of pharmaceuticals can be, according to Kalorama Information.  The healthcare market research publisher said that while some may be taken aback by the three-month production cycle of this compound, those with industry knowledge are well aware of the complex issues of vaccine and other pharmaceutical production, outlined in detail by Kalorama Information in their report, Biopharmaceutical and Vaccine Production Markets. (http://www.kaloramainformation.com/redirect.asp?progid=86761&productid=8357580)

"For many consumers, this is their first introduction to the idea that a drug is simply not available and won't be for months," said Bruce Carlson, Publisher of Kalorama Information.  "For those in the industry it's no surprise.  When you have to create a biological actor, such as a recombinant protein, the production is a complicated process."

ZMapp™ is intended for use with individuals infected with the Ebola virus, but it is too early to know whether ZMapp™ is effective, since it is still in an experimental stage.  In response to the crisis, it was administered and now the supplies of it have been exhausted. However Mapp Biopharmaceutical is working feverishly to produce more, given the spread of Ebola in West Africa and now beyond.

ZMapp™ is a combination of three different monoclonal antibodies that bind to the protein of the Ebola virus. These antibodies are recombinantly manufactured in a variety of tobacco.  The healthcare market research publisher's report discusses this manufacturing process.  In plants with large foliage volume such as tobacco, alfalfa and legume plants, recombinant protein production is performed in the leaves.  Plants offer several potential advantages over other production systems, as they are inexpensive to produce, generating large quantities of biomass at low costs, and do not harbor human pathogens.  Also, plant cells can store recombinant proteins in specialized organs like seeds and tubers, simplifying storage and transportation.

Though work to-date had been funded by grants and contracts that were only sufficient to produce doses for animal safety and efficacy testing, the current outbreak has changed the situation dramatically, and additional resources are being brought to bear on increasing output.  To accelerate ZMapp creation, Mapp Biopharmaceutical is working with the U.S. government to scale up production. 

Kalorama says that emergency use of an experimental medicine is highly unusual.  Biopharmaceutical and Vaccine Production Markets indicates that generally there are still huge challenges during the normally required final stages of clinical drug testing for new biopharmaceuticals, as manufacturers decide when and how to risk production capital to upscale while anticipating FDA or EMA approval. During the past five years, estimates for biopharmaceuticals have varied widely as analysts and producers have juggled the promise of new drugs with the technological and financial risks of manufacturing them efficiently.

The report contains production segmentations for the mammalian cell, microbial cell, monoclonal antibody, other recombinant protein, vaccine, and insulin manufacturing markets, with forecasts to 2018. The current competitive environment is noted, listing selected biopharmaceutical contract manufacturers, selected top-selling biopharmaceuticals, selected Asian biomanufacturing contract manufacturing organizations (CMOs), the top 10 biopharma companies based on 2012 biopharma revenues, and the top manufacturers by global biopharmaceutical manufacturing capacity.

About Kalorama Information -- Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. We routinely assist the media with healthcare topics. Follow us on Twitter, LinkedIn and our blog.

Contact:
Bruce Carlson
(212) 807-2622
bcarlson@kaloramainformation.com

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