The new active pharmaceutical ingredient (APIs) is a version of rosuvastatin, the active in AstraZeneca’s Crestor, that is produced using an enzymatic process that requires fewer solvents, and eliminates buthyl-lithuim entirely.
In addition to eliminating solvents, DSM claims “the technology eliminates the use of many harmful chemicals such as butyl-lithium and the dependency on a very limited number of ATS-8 intermediate suppliers.”
A spokesman for DSM Sinochem, an organistion set up with Sinochem in which DSM holds shares, told in-Pharmatechnologist.com that: “At the moment the main ATS-8 manufacturers, which service the merchant market globally, are located in China.
He declined to name any of the Chinese suppliers, but did stress that: “We do not buy from any of them. We manufacture our own intermediate in our highly efficient production process.”
He explained that: “Our innovative production process [which was runner up at the CPhI Innovation awards last week], uses our own enzyme DERA [deoxyribose phosphate aldolase] to efficiently manufacture our intermediate.”
The firm also claims that the enzymatic method results in a carbon footprint that is 35% lower than traditional approaches to statin manufacture and produces purer, more stable actives.
DSM has been involved in the development of enzymatic production methods for APIs for the past few years through partnerships with c-Lecta and Codexis, the latter of which has been developing a way of making ATS-8 using enzymes since 2006.
The agreement with Codexis, signed in 2011, was followed a year later by DSM’s receipt of Certification of Suitability to the Monograph of the European Pharmacopoeia (CEP) for generic atorvastatin.
However, according to the DSM Sinochem spokesman the new version of Rosuvastatin and indeed the version of enzymatically produced Atorvastatin also sold by the firm under its PureActives brand, relies on separate technology.
“[This is] unrelated to the granting of the CEP for Atorva and also unrelated to any events with Codexis" he said, adding that "we do not use the Codexis enzyme for our statins."