ProMetic and Novartis team up for new vaccine purification technology

Under the terms of the agreement, the two companies will develop a synthetic-ligand affinity adsorbent for the purification of recombinant protein vaccines, that Novartis will use for a new vaccine product it is currently developing. According to ProMetic, its range of synthetic ligands, called Mimetic ligands, to be used during the manufacture of biological drugs are more efficient and cheaper than standard ligands - derived from biological sources - due to their higher selectivity robustness and lower cost. "They are small molecules made by synthetic chemistry and can be produced at relatively low cost and completely free of anything of biological origin including animal viruses or prions,"​ a ProMetic spokesperson told In-Pharmatechnologist.com.​ She added that Mimetic ligands are completely safe and non toxic and are too small to be antigenic therefore can't cause an adverse immune reaction. "This is very important in this context as most vaccine products contain agents to stimulate the immune system therefore the only antigenic material present should be the vaccine itself,"​ the spokesperson said. These advantageous features could provide significant benefits to pharma companies, and to Novartis in particular, including simplicity of use, increased safety, high levels of purification which can reduce the need for additional purification steps. "Mimetic ligands provide biopharmaceutical manufacturing companies with numerous advantages, particularly for large-scale production of price-sensitive products,"​ ProMetic said. Neither the name of the vaccine Novartis will use the ligands for, or the financial details of this partnership were revealed. "It is a protein vaccine, a viral coat protein antigen which is produced by genetic engineering but we are not at liberty to say which disease the vaccine is intended to prevent at this time,"​ the ProMetic spokesperson told In-PharmaTechnologist.com.​ This new agreement illustrates the growing interest of drug makers in the highly lucrative vaccine market and could prove an interesting deal for ProMetic, as it means a secure future revenue stream for the lifetime of the pharmaceutical product. "This latest agreement is further recognition of ProMetic's prominence and successful track record in the development of affinity ligand products for bioprocess applications,"​ said Steve Burton, chief executive officer of ProMetic Biosciences. Conventional approaches to bioseparation generally involve the use of a lengthy series of individual purification steps to achieve the desired level of product purity, therefore with each step employed product losses are incurred and processing time and costs go up. Thanks to its high selectivity, Prometic's Mimetic Ligands technology provides a means of reducing the overall number of individual steps. This is achieved by use of small chemical affinity ligands designed to specifically bind to the target biomolecule, in this case hyperimmune antibodies. As the ligand only binds to the target protein, other non-bound components and impurities can be removed by washing, after which the target protein is recovered by changing the washing solution to favour desorption, allowing simultaneous concentration and purification and resulting in recoveries approaching 100 per cent. To find the ligands capable of binding to a specific site on a protein, Montreal-based Prometic uses computer-aided molecular design and the synthesis and screening of combinatorial ligand libraries to aid ligand selection. Apart from investing heavily in this technology, Novartis made its big entrance in the US vaccine manufacturing scene last April with the $5.4bn acquisition of Chiron, the troubled vaccine maker whose Liverpool facility was shut down in 2004. In the company's second-quarter financial results announced this week, Chiron's acquisition weighted on Novartis's profits, wiping out some of its strong sales but still allowing a 7 per cent rise in pre-tax profit to $2bn (€1.5bn).