Complementary offer
Heather Delage , chief commercial officer , said that Biovectra , opened a biomanufacturing centre in Canada in November 2023 , focusing on plasmid DNA , mRNA and DP manufacture . More recently , it formed a partnership with Acuitas that will demonstrate GMP manufacture of its LNP platform .
However , investment goes on into chemistry and large-scale chemical purification for APIs , as the company sees chemistry and biology as very much complementary to each other . “ We see opportunities for additional investment in both of these capabilities ,” she said . Business remains strong , based on its strong regulatory record , commercial experience , and novel manufacturing offerings .
The largest among many other investments Actylis has made in the seven sites it has acquired in the last three years is a new GMP API facility at Eugene , Oregon , using its hybrid model of manufacturing and distribution . This has five suites for Phase III to commercial manufacturing and is going through validation .
There is still scope for more , according to Timothy Quinn , VP and general manager of pharmaceuticals . “ What makes the difference with our site is that you not only have to know what the customer needs , you need the right project management and quality , and it has to work together .”
Actylis still sees some continuing weakness among biotechs in Phase I-II but this is recovering as funding works its way through . The company has certainly been hitting its numbers in the later phases since late 2023 , with small molecules to the fore . As Quinn noted , the FDA is still approving more small molecules than biologics .
Aragen is adding biologics capacity inside and outside India
Small is beautiful
For all the focus on biologics , said David Molyneux , VP of business development at Sterling Pharma Solutions , small molecule business will never disappear . “ If you look at the innovation , the new areas are growing at a faster rate but small molecule is still growing and is still most of the market .”
As more pharma companies diversify into novel technologies , he added , they are actually more likely to outsource ‘ older ’ capabilities to CDMOs in order to focus on biologics .
IRA hits Chinese players hard
Among the CDMOs shown by Daniel Cohen to have enjoyed strong share value growth in 2023 , there was a glaring exception . WuXi Biologics ’ share price was 50.5 % down in 2023 . Unlike others whose value fell that year , there has been no recovery so far in 2024 and it had fallen a further 36.5 % by the time of DCAT Week .
This is largely the result of the Inflation Reduction Act ( IRA ), one of whose consequences has been overt and informal pressure on US companies in all fields to outsource less to China . The Biden administration has identified certain companies as threats to US security and sanctioned them . WuXi AppTec is not among them , although there are claims that one reason it had got so much business was a tacit understanding that placing projects with them would ease the approval of the final drug in China .
Whatever the case , the company has felt the effects . Ahead of DCAT Week , the three co-CEOs sent an open letter to customers expressing their concern about “ a misguided US legislative initiative to target our company without a fair and transparent review of the facts ”.
While welcoming regulatory oversight , they said , “ we strongly object to blanket allegations and preemptive actions against our company without due process … We are confident that upon considering the facts , US lawmakers will understand that WuXi AppTec does not in any way pose a national security risk to any country .”
The immediate effect , according to some SCM spoke with , has been to leave customers scrambling for alternative capacity elsewhere . Given that , according to CBO Yu Lu , WuXi AppTec was involved in 27 % of the small molecule drugs approved by the FDA in 2023 , this seems
28 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981