SynCo Bio Partners, a world leading GMP contract manufacturer of biopharmaceuticals, today announced that one of its customers, PaxVax, has received FDA approval for Vaxchora (TM), a single-dose oral, live attenuated cholera vaccine, indicated for use in adults 18 to 64 years of age. Vaxchora is the only vaccine available in the U.S. for protection against cholera and the only single-dose vaccine for cholera currently licensed anywhere in the world. The bulk drug substance for Vaxchora is manufactured at SynCo Bio Partners' Amsterdam facility.
SynCo Bio Partners has supported PaxVax with the clinical development program of Vaxchora, including Phase III clinical bulk drug manufacture and supply, process validation, FDA pre-approval inspection for product registration and manufacture of pre-commercial supply.
Pierre Warffemius, CEO of SynCo Bio Partners comments: "For both companies, it is a defining moment that PaxVax has received FDA approval for Vaxchora. The approval is the outcome of excellent teamwork, mutual sense of responsiblity and a strong emphasis on quality, demonstrating the value of a long term commitment between the two companies. We look forward to continuing our support to PaxVax, by ensuring safe, compliant and cost effective manufacturing of the commercial Vaxchora vaccine."
"Cholera is an underestimated disease that is found in many popular global travel destinations and we are proud to provide the only licensed vaccine in the United States against this potentially deadly pathogen" said Nima Farzan, CEO and President of PaxVax. "Achieving FDA approval is an important milestone for PaxVax and a testament to our unwavering commitment to producing vaccines of the highest quality. SynCo shares this commitment and has been an important partner in bringing Vaxchora to market."
In addition to the approval of Vaxchora, SynCo Bio Partners manufactures several other microbial expressed biopharmaceuticals for different US and EU-based customers, which are expected to be filed for product registration in the US and other countries within the next few years. The approval of Vaxchora for the US market adds to SynCo Bio Partners' already established commercial supply products and further strengthens SynCo Bio Partners' position to supply both commercial as well as clinical products on a truly global scale. It is on these foundations that SynCo Bio Partners is able to commit to the long term support of its customers and its ultimate goal supporting patient health worldwide.
About SynCo Bio Partners
SynCo is a biopharmaceutical GMP Contract Manufacturing Organization located in Amsterdam, the Netherlands, licensed for clinical and commercial GMP manufacturing of Bulk Drug Substances and Drug Products. As a truly global player, SynCo offers a fully integrated range of biopharmaceutical development and manufacturing services supporting small biotech to large pharmaceutical organizations worldwide from the earliest stages in process development, through pre-clinical and clinical trials, (biologics) license approval and market supply. Trust us to make it right! For more information, please visit http://www.syncobiopartners.com
Source: SynCo Bio Partners
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