NEWS
CDMOs in bio advances
Four global CDMOs who are all arguably better known for their traditional chemistry services have been involved in investments or manufacturing deals on the biotech side in recent months . Much of this has been in antibodydrug conjugate ( ADC ) capabilities , on the back of growing interest in this modality in the treatment of cancer , which has been forecast to grow at 15 %/ year to 2028 .
Sterling Pharma Solutions will invest £ 10 million to more than double GMP bioconjugation capacity for ADCs in a 215 m 2 suite with reactors of up to 500L in volume at its site in Deeside , UK ( pictured ). There will also be a 130 m 2 Grade C cleanroom for manufacturing using flexible and hard containment technologies to handle highly potent molecules with exposure limits down to 0.01 µ g / m 3 .
Sterling ’ s ADC business has also agreed to make Phase I clinical trial volumes of GlycoNex ’ s GNX102-ADC at its site in Deeside , UK . This humanised monoclonal antibody ( mAb ) is designed to target novel tumour-associated glycans to inhibit tumour growth and has already cleared Phase I trials . It is now being combined with a cytotoxic in an ADC that will seek to elicit cellular cytotoxicity to target cancer cells of many types with high specificity .
Processing will take place within flexible , single-use bioreactors to increase efficiency and eliminate the potential for cross-contamination between campaigns , with integrated automated transfer and control systems to reduce the need for manual operations , the company added , while stability chamber capacity for the storage and monitoring of final products will be upgraded . This should be complete in early 2026 .
Meanwhile , Merck KGaA is to spend € 70 million to triple capacity at its Bioconjugation Centre of Excellence facility in St . Louis . It will add 3,200 m 2 more space for process and analytical development , QC , R & D , manufacturing and logistics , plus a dedicated buffer preparation facility , and a cold storage and a GMP-controlled room temperature warehouse close to the existing facility .
This follows on from the opening of a € 59 million , 6500 m 2 facility in Verona , Wisconsin , dedicated to doubling production of the most highly potent APIs , in 2022 , and other technology innovations in the field . Merck , known as EMD in the US , was the first CDMO to be approved for ADC manufacture in the US .
Lonza is to add two multi-purpose , 1,200L manufacturing suites plus related infrastructure to the bioconjugation facility in Visp , Switzerland , for launch and commercial supply . When this becomes operational from 2028 , it will add 2,000 m 2 and double Lonza ’ s bioconjugates capacity for ADCs and other products . This follows an earlier customer-specific expansion in bioconjugates at the site .
On the deal side , Cambrex has signed an agreement to partner with Lilly Catalyze360-ExploR & D , Eli Lilly ' s early external innovation and collaboration arm , to provide drug substance , drug product , analytical service labs and R & D expertise to biotech collaborators . Primary services will come from the site at Longmont , Colorado , which specialises in the early development of INDs .
Finally , Seqens ’ CellForCure cell and gene business will industrialise clinical batches of Smart Immune ’ s Smart101 , which is in Phase I / II trials for patients with acute leukaemia or primary immunodeficiencies in the EU and the US . Seqens said that CellForCure ’ s capacity will complement Smart Immune ' s existing capabilities to support its expanding clinical development , as well as new proof-of-concept trials in solid tumours .
8 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981