Sterile manufacture at Piramal’ s Lexington site
This site also offers development and small-scale manufacture of peptides.
The two key investments from Piramal Pharma Solutions( PPS) have been in the US and total $ 90 million. One is at the sterile fill-finish facility at Lexington, Kentucky, to double fill volume and increase lyophilisation, in response to strong demand for onshore fill-finish and a lack of capacity when most is being soaked up by GLP-1s.
PPS is also adding a second linkerpayload suite for ADCs at the former Ash Stevens facility in Riverview, Michigan, because the first was full. This should be operational by the end of the year, said CEO Peter DeYoung. Further expansions are taking place in oral solid dosage forms at Sellersville, Pennsylvania, in tableting at Morpeth, UK, and at the discovery labs at Ahmedabad, India.
“ We can now do drug product and drug substance onshore in the US,” DeYoung said.“ We have capacity available tomorrow if someone wants to do a tech transfer for supply chain security considerations. We believe we are well positioned and we have seen some uptick in the funding environment in the last three months, as well as the onshore push.”
This is all driven first and last by customer signals, DeYoung confirmed. PPS believes the US is a good place to do business, whatever the administration may be doing. Currently, India and the UK both have favourable tariff profiles. Its global network enables it to offer everything from full onshoring to none. Axplora has invested $ 100 million across its network this year
Like a few other CDMOs, PPS has reorganised its sales structure to reflect the different needs of Big Pharma and biotech companies. It commissioned a benchmarking exercise of its competitors and found, perhaps surprisingly in the days of integrated packages, that sales by business line are still the norm.
PPS has also been able to share some details from a customer in New Amsterdam Pharma, for whom it has been developing a complex combination drug for LDL cholesterol across three sites.
Development took place at Ahmedabad, where PPS has most of its scientists. The product is dualsourced at an Indian site for value and at Sellersville, Pennsylvania, for proximity. PPS and New Amsterdam co-invested in a dedicated suite.“ We think not many of our competitors can bring East and West together in a non-China option like this,” said CEO Peter DeYoung.
Biological options
BioVectra is in a unique position in two ways. Its primary manufacturing base is in Canada, which may become subject to tariffs at some point; and it is now a subsidiary of an instruments company, Agilent, which is looking to build out its CDMO offer now that the integration has been completed.
14 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981