Also in ‘ tides ’, CordenPharma has just commissioned two lines of different scales to manufacture early clinical-phase peptide APIs at its Frankfurt site . This has added 1,000 m 2 of space , including two fully equipped lines comprised of SPPS and LPPS synthesisers , highpressure liquid chromatography , isolation equipment and QC labs .
The expansion will be fully operational in Q2 , said Dr Stephen Houldsworth , senior VP of global pharmaceutical management and marketing . It will produce peptide APIs from gram to kilogram range for Phases I-II and transfer to the late-phase and commercial site in Colorado , where a 10 m 3 SPPS line , a chromatography skid and related infrastructure were added last year .
Other expansions have taken place in OSD at Plankstadt , Germany , both to grow the company ’ s bioavailability enhancement group and to enable it to work on the oral delivery of peptides and oligonucleotides . There has also been a new line for encapsulation and new scale-up capabilities for LNPs at Caponago in Italy .
In the same field , the Almac Group has completed two new purposebuilt facilities at its headquarters in Craigavon , Northern Ireland : a 2,600 m 2 GMP facility that more than doubles peptide API manufacturing capacity and completed a 3,000 m 2 high-volume facility for the manufacture and packaging of sachet DPs . The total investment is about $ 400 million .
Small molecule investment
CSO Matt Bio announced during DCAT Week that Cambrex will complete its five-year , $ 100 million dollar investment programme by the end of 2024 , one year ahead of schedule . The project will add capacity across its drug development and manufacturing network , spanning “ all scales of clinical and commercial DS manufacturing ”, including “ advanced technologies related to complex molecules ”.
The additions include smallvolume , large-volume and highly potent API manufacturing at two US sites , supported by specialised technologies for continuous flow process development and complex synthetics at the former Snapdragon site ; a high potency lab for API processes and analytical development in Italy ; a stability storage facility in Belgium ; and two new 6 m ³ -scale production lines in Sweden .
Japan ’ s AGC Pharma Chemicals announced the completion of a $ 100 million expansion in APIs and HPAPIs at its site near Barcelona . It will come onstream in 2025 . This will add 30 % to capacity in reactors of 1.5-7.5 m 3 in 1,500 m 2 of floor space . The site is also equipped to expand flexibly for specific customer needs .
Likewise , Polpharma API is investing $ 28 million in an HPAPI facility at its main site in Starogard Gdanski , Poland . Manuel Lourenco , head of Polpharma CDMO , said that it will make products down to occupational exposure limits of ≥10 ng / m ³. Capabilities will include ADC compounds and the site will feature
Almac Group has doubled peptides capacity at its HQ site
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