In its first show as a standalone organisation Archimica, formerly known as the Pharmaceutical Fine Chemicals business of Clariant, highlighted its 100% pharmaceutical fine chemicals focus and opportunities for growth.
The company has invested heavily in a range of expansion projects at its facilities in Springfield, Missouri, as well as at sites in Italy, the UK and the southwest of France. According to Ralf Pfirmann, global business director, the investments will add differentiated capacity and capability, focusing on cGMP manufacturing and on technologically intensive activities.
The initiatives include a $6m expansion in support of an antiviral API at Sandycroft, UK, and Origgio, Italy. Sandycroft will undertake the manufacture of cGMP intermediates while its cGMP Centre of Excellence - Origgio/Isso - will become involved in finishing the bulk API. The work at the Sandycroft site will take advantage of its expertise and capability in regulated, high intensity chemistry in manufacturing a chiral epoxide by highly challenging process chemistry. The investment in the UK will represent 60% of the total project investment.
A further $1m is being invested at the Bon Encontre facility in the southwest of France to support the manufacture of a life-saving antibiotic destined for the US market.
Archimica has also continued to expand the capabilities of its main US site in Springfield. One of the key expansions supported the manufacture of a major antiviral drug and featured the development of a large-scale titanium tetrachloride capability. This technology has been used more frequently in the laboratory in the past, and its use on the large scale opens up a range of new options for the use of this versatile, highly reactive reagent, said Pfirmann.
Archimica also undertook significant expansions in support of its controlled substance manufacturing. It began producing a DEA-regulated opiod earlier this year, and has also begun manufacturing the attention-deficit drug methylphenidate and its single enantiomer counterpart dexmethylphenidate as bulk actives at the Springfield site.
In addition a number of new generic APIs are already being or will be manufacture for the US and European markets at multiple locations throughout Archimica's manufacturing network. These new products include oxacarbazepine, methylphenidate and dexmethylphenidate, stavudine and didanosine, each of which will be produced as a bulk active.
The company has added several new commercial scale technologies to its global manufacturing network that will enhance its ability to support the manufacture of cGMP intermediates and APIs. They include the use of titanium tetrachloride at the company's Springfield site, a broad ranging chiral epoxide capability and new methodologies to manufacture heterocyclic boronic acids.
'Our technology development includes the development of new routes and new compounds, but importantly it involves our ability to conduct these reactions at a commercial scale,' said Pfirmann. 'We have been very successful in taking what has previously been chemistry conducted only at the laboratory level and moving it into large scale applications with excellent results.'
