From DCAT Week 2023: Supplier News: End-to-End (Drug Substance and Drug Product) Mfg

A roundup of news from CDMOs/CMOs and suppliers in both drug-substance and drug-product development and manufacturing with news from CordenPharma and BioDuro Sundia. Highlights below.  

* CordenPharma Expanding Peptide & Aseptic Filling; Adding Oligonucleotide Mfg 
* BioDuro Sundia Expands in the US and China 

CordenPharma Expanding Peptide & Aseptic Filling; Adding Oligonucleotide Mfg 
CordenPharma, a CDMO of drug substances and drug products, is proceeding with continued investment in its manufacturing capabilities and capacities across all its technology platforms. Three significant expansions in 2023 are outlined below.   

• In CordenPharma Colorado (US), the company is investing approximately $30 million to build a new 1,000-L peptide synthesis line with full process analytical technology (PAT) automation & support systems, including a new 60-cm chromatography skid with appropriate support vessels. 

• In CordenPharma Caponago (Italy), the company is investing EUR 30 million ($33 million) into a new commercial aseptic filling line with isolator technology. Both expansions already started in the first quarter of 2023, with completion slated for the second half of 2024. 

• CordenPharma is also adding a sixth innovative technology platform, oligonucleotides. As the manufacture of high-quality, GMP oligonucleotides at all scales is in high demand, CordenPharma sees the introduction of oligonucleotide manufacturing at its Colorado facility as a natural extension of its “Tides” portfolio. The addition of oligonucleotides also pairs well with its lipid nanoparticle (LNP) formulation and aseptic fill–finish processing capabilities under the company’s injectables platform. Phase 1 of the expansion plan involves an investment of EUR 25 million ($27 million) in 2023, with further phases in later years to represent an approximate EUR 75 million ($82 million) total investment.  

Source: CordenPharma

BioDuro Sundia Expands in the US and China 
BioDuro-Sundia, a contract research, development and manufacturing organization of drug substances and drug products, has announced the opening of five separate site expansions in the US and China to boost its global operational capacity by more than 100,000 square feet for 2023. The company supports the entire drug-development process from target identification to commercial manufacturing.  

Source: BioDuro-Sundia