 In addition, the company is developing its own platform of Biosimilars and “Biosimilars Plus”, which is offered for sponsorship to large pharma companies. PPS is currently establishing its own FDA/EMEA-compliant, state-of-the-art manufacturing plant, which is planned to be operable by mid 2012.Potential customers for the plant include: · Companies with products at phase I/II looking for a FDA/EMEA-compliant manufacturing facility for the provision of product for Phase III and market · Companies with a registered product looking for a FDA/EMEA-compliant manufacturing facility as a back-up for the provision of product for sales Technology The Protein development and production technologies of PPS include microbial and mammalian cell line development, upstream and downstream process development, analytical methods development, cGMP manufacturing and stability studies. Several Biosimilars and
“Biosimilars Plus” products are currently in various development stages, of
which Factor VIIa is the most advanced. The current version of Factor VIIa on
the market is used for uncontrollable bleeding in hemophilia patients that have
developed inhibitors against other coagulation factors. PPS is developing
Factor VIIa in a spray for the treatment of Diffuse Alveolar Hemorrhage (DAH),
a clinical syndrome resulting from blast lung injuries or various disorders. Treatment
with Factor VIIa will address unmet healthcare needs in cases of DAH, which is
a cause of death of over 100,000 patients annually, with the potential to be
higher in cases of terrorism and warfare. An effective haemostatic therapy may
be capable of reducing DAH’s high mortality. Contact
Details Exhibition
Representative Category: Pharmaceutical/Biopharmaceutical |
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