PHARMA SPECIAL
Roth said . Even though CDMOs have no involvement in drug shortages , they are inevitably “ dragged in to conversations about solutions ”. Finally , Roth highlighted how new modalities are affecting both the drug pipeline and the CDMO space , particularly cell and gene therapies ( C & GT ). CDMOs have made massive investments to ensure they have capacity for the expected growth . Some drug developers are developing their own capacity , partly as a hedge in case of candidate failures or C & GT taking longer than expected to develop .
Seqens ’ for instance , moved into C & GT for the first time this year by acquiring Cellforcure , a startup based at a former Novartis site south of Paris . Cellforcure also has capabilities in areas like biocatalysis , microbial DNA modification , analytics and R & D services .
Veranova ’ s Shackley said interest in its ADC capabilities is high . “ The industry in general has seen a lot of activity at customer level with ADCs , such as Merck ’ s potentially multibillion deal with Daiichi Sankyo .” Also in ADCs , Olon has begun a new building at its Rodano site for ultra-potent compounds used as ADC payloads and payload-linkers .
C & GT has been heavily hyped and some believe that it will take a long time to deliver , rather like ADCs before . There is also cynicism in some parts about the other buzzwords du jour , including flow chemistry , which is still far from displacing batch , and personalised medicine .
“ Most Big Pharma companies haven ’ t really delivered on personalised medicine ,” said Robinson of Navin Molecular . “ I don ’ t believe we will be making individual medicines for a while yet . However , he has seen growing interest in water-based chemistry , while Kevin Daley , market director - pharmaceuticals at Axplora , cited electrochemistry and continuous processing as areas of growing interest
Demand for integration
“ Business is good , we can ’ t grow quick enough and it has shown no signs of slowing down in the last five years ,” said Denis Geffroy , VP of business development at Almac Group . In the last two years in particular , Almac has seen increasing requests for integration of drug substance ( DS ) and drug product ( DP ) on a single site .
This trend was already ongoing but , in Geffroy ’ s view , was greatly accelerated by COVID and the consequent desire to secure the supply chain . In part driven by this , Almac has spent £ 65 million to boost DP capabilities at its largest site in Craigavon , Northern Ireland . A new , 9,300 m 2 GMP multi-purpose facility will come online in Q3 2024 , mainly to support solid oral dose products , including high-potency .
Now that more than half of Almac ’ s business is in the US , it is also building a new DP facility in Souderton , Pennsylvania , that should come onstream in 2025 . This will also have analytical capabilities for APIs and biologics .
During CPHI , Indian-based CDMO Aragen announced a $ 30 million biologics facility in Bangalore that will offer intensified processing using single-use bioreactors and advanced downstream purification . Not a week before , it had commissioned a 1,100 m 2 formulations facility in Hyderabad , to support clinical manufacturing of dosage forms .
Like Almac ’ s , Aragen ’ s new biologics facility will offer integrated services . They will range from process development to process validation , analytical development , pilot production and large-scale DS manufacture , plus mAbs , therapeutic proteins and fusion proteins .
Networking on the show floor
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