MIP taking separation tech to commercial scale
binding properties, has signed a deal which could take its
technology out of the laboratory sector and into the realms of
large-scale production of pharmaceuticals.
FeF Chemicals, a manufacturing unit of Danish pharmaceutical company Novo Nordisk, will look at using the polymers as a separation technology for large-scale protein purification. Very little detail about the project is being divulged, but it appears that the MIP polymers will be used to remove a contaminant from the process for making a drug, likely in the diabetes arena.
Tony Rees, MIP Technologies' chief executive, told In-PharmaTechnologist.com that the agreement with FeF is the first to look at using its polymers on a production scale.
He explained that the company's MIPs - or molecularly imprinted polymers - can be constructed with artificial binding pockets that can latch on to a wide range of chemical and biologic molecules. In simple terms, the polymers are made by surrounding a drug in solution with monomers that interact with the surface of the molecule. These are then polymerised - joined together - to create a three-dimensional polymer network around the template molecule. Wash out the template and you are left with a pocket, somewhat like a plaster of Paris casting on a molecular scale, which can bind the target.
At present, MIPs are finding applications in laboratory-scale separations, and MIP Technologies is already selling products aimed at the drug discovery and food technology sectors. For example, the company has just launched a new product aimed at taking vitamin B2 (riboflavin) out of dairy products, beer and wine.
At present, these products are made by creating the MIP polymers in a block, and then grinding them down and sieving them to the desired particle size for use as a solid phase in analyses such as high performance liquid chromatography (HPLC). The resulting polymers have superior performance compared to regular HPLC media, as they have affinity for the desired analyte built in, and are also more stable to factors such as heat, acid/alkali and solvents.
At large scale this production approach does not work, mainly because the creation of the polymeric block generates a lot of heat and potentially becomes explosive. This limits the yield to the kilo scale. To improve on this, MIP Technologies has developed two potential solutions to this problem that should allow it to make polymer in quantities suitable for process applications.
In one approach, the polymer is made as a film that is coated onto porous silica, in a proprietary process the company calls grafting. This can take MIP production up to the tonne scale. In another, the polymerisation can be carried out as a suspension in a large excess of water, which leads to the creation of polymer in beads, rather than blocks. This can cater for production at the 200-500 kilo level, but has some limitations, for example if any of the constituents of the reagent mix are soluble in water it can have a detrimental effect on yields.
Rees said he envisaged MIPs being used in the pharmaceutical production arena in industrial-scale columns that would be used to extract a component or contaminant from a production vessel, more simply and efficiently than using current separation methods. The polymer could also easily be regenerated and re-used by washing the column out with an eluting solution, he noted.
MIPs can be designed with exquisite selectivity, such that they could even be used to separate one chiral form of a molecule from its twin, and to separate peptides or proteins from complex mixtures. The company has developed a way of making MIPs that recognize the specific amino acid sequences at the ends of proteins, which could lead to separation applications for biologic drugs made via bacterial fermentation.
The agreement with FeF will see MIP Technologies receive funding and milestone payments during the development of the new material, while FeF/Novo Nordisk will get exclusive rights to its manufacturing and use. The Swedish company will retain the right to use it in applications outside diabetes.
Rees could not comment on the timeframe for completion of the FeF project, but said that typically an MIP would take six months to develop an make on a small scale, not including scale-up to pilot and commercial capacity.
