SynCo Bio Partners B.V. has signed two commercial manufacturing agreements with an undisclosed US biopharmaceutical company. Under the contract, SynCo will provide both process validation and GMP commercial manufacturing services to support the commercial launch of two separate biopharmaceutical products onto the US market.
SynCo has commenced with preparations for the manufacture of conformance lots in advance of its client's BLA filings, expected in late 2010, in anticipation of commercial manufacturing commencing in 2011.
The products are both recombinant proteins, to be produced in E. coli. These products will be manufactured in SynCo's large-scale GMP facility and take the tally of marketed products manufactured at its Amsterdam facilities to six, since SynCo's inception in 2000. SynCo has previously supported process development efforts for both products; an excellent example of how SynCo supports its clients' biopharmaceutical development programs from early stage to commercial supply.
Pierre Warffemius, CEO of SynCo Bio Partners said, "This news is a further example of how SynCo can offer a viable long-term manufacturing choice to its clients. SynCo has grown steadily over the last ten years in a very competitive market. The foundation of this growth has been our ability to form strong and mutually beneficial relationships with our clients. As a consequence, SynCo is one of few biopharmaceutical CMOs in the world with a recognized track record in both clinical and commercial manufacturing, providing financial stability that allows us to continuously invest in our facilities."