PHARMACEUTICALS
facility would be operational for clinical and commercial supply in 2H 2024 . This has 20 m 3 of DS capacity plus two high-speed vial filling lines capable of producing up to one million vials / day in 1-100 ml fill volumes . This will triple biomanufacturing capacity . Syngene also plans to expand into ADCs and CGT .
Another Indian player , Aragen , announced in New York that it had operationalised the first phase of its $ 30 million biologics manufacturing facility in Bangalore . The facility will carry out GMP and non-GMP manufacturing in singleuse bioreactors with capacities of up to 2 m 3 and will offer many services including large-scale DS manufacturing .
Across the board
Thermo Fisher Scientific is investing in many areas across its 60-site network , said Jennifer Cannon , President of Commercial Operations , Pharma Services at Thermo Fisher Scientific . This includes doubling capacity for prefilled syringes at Ferentino , Italy , plus dedicated lines at two other sites in Italy and the US .
The company will also be adding : biologic DS capacity at Lengnau , in Switzerland , in 5 m 3 and 12 m 3 reactors ; 2,300 m 2 of extra space for RNA-based products at Monza , Italy , with all the capabilities under one roof ; 2,800 m 2 of oral solid dosage ( OSD ) capacity at Cincinnati , including fluid-based processing ; and , 1,400 m 2 of space in ‘ flex suites ’ tailored to specific customer processes at its main process development site in Bend , Oregon .
Fujifilm Diosynth Biotechnologies has invested nearly $ 8 billion over the last four years , CEO Lars Petersen told DCAT Week delegates . The first expansion to come online this year will be a $ 1.6 billion cell culture facility in Denmark , with an identical site to follow in two years . ADCs are also part of this .
Another $ 2 billion cell culture site will open in Holly Springs , North Carolina , in 2025 with space for
42 bioreactors of 20 m 3 capacity and capabilities in DP and finished goods . A similar early-stage facility at Billingham , UK , will bridge the gap between 2-5 m 3 and 20 m 3 scales when it comes online in 2026 .
One traditional chemistry-based CDMO to expand its platform into an entirely different field in biologics is Seqens , which has acquired Cell for Cure , a CGT business , from Novartis . The move , said CEO Pierre Luzeau , “ was guided by the conviction that in the coming years , innovation in this segment represent the future of medicine ”.
Time and tides
Investing on a massive scale across the board is China ’ s WuXi AppTec . CBO Yu Lu announced that its newest and largest ( 53 hectares ) site at Taixing opened in January . Once this is complete at the end of the year , it will bring the firm ’ s total small molecule volume , including peptides and olignonucleotides , to 3,773 m 3 rising to over 6,000 once the rest of the site is built .
The company added peptide capacity at Taixing and Changzhou in 2023 , bringing the total to nearly 32 m 3 . More will come this year at Taixing and a new site in Singapore . At present , it is working on 48
CordenPharma is investing heavily in oligonucleotides
peptide projects at all scales . It has also completed 160 oligonucleotide projects to date , she said .
Further additions last year included high potency OSD and injectable lines with capacities of 1.5 billion doses / year and 12 million vials / year respectively , and lipid nanoparticles ( LNPs ), all at Wuxi . The company is seeing rapidly increasing demand for integrated DS-DP projects in peptides and oligonucleotides , said Lu .
Similarly , South Korean smallmolecule oligonucleotide and mRNA CDMO ST Pharm , is expanding oligonucleotide API capacity at Bandola , said Kris S . Choi , senior VP of marketing and business development . In all , it will spend $ 110 million , on antisense oligonucleotides and RNA capabilities in a new ‘ Oligo Plant 2 ’.
Porton Pharma Solutions is furthering its global expansion in China , the US and Slovenia , announced chairman and CEO Oliver Yu . This covers peptides , oligonucleotides , and complex conjugates as well as small molecules , and includes various capabilities , including solidphase , ( SPPS ) liquid-phase ( LPPS ) and hybrid-phase peptide synthesis , siRNA , miRNA , aptamer oligos and ADCs .
MAY / JUN 2024 SPECCHEMONLINE . COM
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