NEWS
Multi-track investment for CordenPharma
CDMO CordenPharma is planning to invest heavily in all its platforms in terms of both capacities and capabilities , according to Dr Stephen Houldsworth , global head of platform management and marketing , at CPhI Worldwide in Milan . Subsequent announcements have fleshed this out . Non-GMP peptide capacity has been added at Fechenheim , Germany , enabling the firm to manufacture at hundreds of grams scale for tox studies and other non-clinical work . “ This gives us the ability to develop the process and make the demonstration batches at the same site before we take it over to one of our GMP manufacturing facilities ,” Houldsworth said . “ We are also in the finalisation stages of a huge expansion there to manufacture GMP peptides as well . We ’ ll have small-scale GMP manufacture in both Europe and North America , both solid- and liquid-phase .” Earlier , CordenPharma had increased its peptide purification capabilities in Colorado , adding a one-metre column . Multiple customers are bringing many more peptide drugs through the clinic that , if successful , will require largescale manufacturing . Even on the show floor in Milan , it was receiving enquiries , some from customers it had not previously known to be active in peptides . There is also growing interest from customers in new formulation developments in peptides , both oral and inhalation . Tying in with this on the injectables side , the company has broken ground on an both an R & D facility and a clinicalscale manufacturing facility for lipid nanoparticle formulation development at Caponago , near Milan . “ We see the lipid nanoparticles as being the future for things like peptide and
Large-scale peptide manufacturing at CordenPharma
oloigonucleotide formulations ,” Houldsworth said . CordenPharma is already one of the world leaders in large-scale lipid manufacturing , having scaled up “ dramatically ” to meet the needs of Moderna ’ s COVID-19 vaccine . In the process , it added capabilities like supercritical fluid chromatography at its sites in Wiestal , Germany , and Chenôve , France , plus large-scale manufacturing capacities in the field . The firm has also since confirmed a € 9.7 million expansion in development capabilities for the development and manufacture of highly potent oral solid drug products at Plankstadt , Germany . This will bridge the gap between an existing 5-20 kg GMP facility and two production facilities , making GMP batches up to 50 kg . It is also adding high potency filling equipment , hot melt extrusion and the ability to operate with organic solvents . CordenPharma has recently agreed to buy the drug products business of Vifor Pharma Group , comprising sites at Fribourg and Ettingen in
Switzerland , and Lisbon , Portugal . The deal , which includes an ongoing supply agreement , is expected to close in Q1 . The sites will be organised under CordenPharma ’ s small molecule platform . Earlier , the firm completed the first phase of an investment in a centre of excellence for flow chemistry at Chenôve . To date an R & D laboratory has been renovated using advanced flow chemistry equipment . The second phase has also been initiated , including a dedicated GMP flow chemistry pilot facility . It will consist of flexible equipment that will enable it to manufacture multiple 100 kg quantities , depending on reaction parameters and throughput . The rapid expansion is reflected in and facilitated by extremely strong growth in the pharmaceutical market as a whole , according to CEO Michael Quirmbach . While the company does not disclose detailed figures , it expects to have sales of over $ 750 million this year , up from $ 387 million in 2019 and $ 500 million in 2020 .