#CellularOrigins, #CGTCatapult and #ResolutionTherapeutics form consortium to deliver fully automated #robotics #cellandgenetherapy #manufacturing platform with £1 million grant from #InnovateUK. #celltherapy #biomanufacturing #celltherapies #automation

#LotteBiologics and #AbTis team on the development of next generation #AntibodyDrugConjugates, combining AbTis' AbClick #linker technology with Lotte's #conjugation #manufacturing capabilities at its Syracuse #ADC site. #CDMO #biotechnology #biotech #ADCs

#FDA's #CompleteResponseLetters reveal 74% of applications were rejected for #quality/#manufacturing issues. Here are 9 "of interest" applications initially rejected for #CMC issues, according to Jefferies analysts. #pharmamanufacturing #regulatory #pharma.

#Myrtelle teams with #CharlesRiverLaboratories and #ViralgenVectorCore on commercial #manufacturing of #genetherapy. The #CDMOs are helping to prepare for potential launch of MYR-101 for #Canavandisease, pending regulatory approvals. #contractmanufacturing.

#VardaSpaceIndustries has raised $187 million to scale its in-#space drug crystallization lab. The new California lab will focus on developing #microgravity-enabled drug formulations of #biologics, including #monoclonalantibodies. #pharmamanufacturing #VC.

#Trump's 200% #tariff threat on #pharmaceuticals represents both a new high in terms of the proposed rate, and a new low as a potential U.S. #trade policy that could negatively impact global #supplychains. #tariffs #pharmamanufacturing #pharma #onshoring.

#SentioBioSciences spends $10.6 million to expand Missouri #manufacturing site. The added space will support #CDMO services and increase domestic output of APIs, key starting materials and finished drug products. #pharmamanufacturing #contractmanufacturing.

#NovoNordisk invests $115 million to expand #qualitycontrol lab testing at #China site. The 194,000-square-foot lab complex will house chemical, #microbiological and #biological testing facilities to support the growing Tianjin plant's output. #biopharma.

#Hikma's planned $1 billion U.S. investment comes at critical time for #genericdrugs in this country, which account for 90% of #prescription volume and are produced primarily in India. #tariffs #pharmamanufacturing #onshoring #sterileinjectables #generics.

#OfichemGroup has bought #Avivia to bolster its formulation development capabilities and support the #CDMO's strategy of offering end-to-end services from drug substance development through #GMP #manufacturing. #drugdevelopment #pharmaceutical #Netherlands.

#Alvotech buys #IversLeeGroup to boost assembly, #packaging capacity for #biosimilars. The acquisition of Ivers-Lee's Burgdorf, Switzerland site adds #GMP and FDA-approved capabilities in #syringe and #autoinjector packaging. #contractmanufacturing.

#Trump threatens 200% #tariff on drug #imports to get #pharma companies to reshore. #Tariffs on #pharmaceuticals would have a grace period of up to a year and a half to give #drugmakers the opportunity to move their #manufacturing operations to the U.S.

#AlmacClinicalServices, part of the #AlmacGroup, has expanded #coldchain capacity at its #NorthernIreland facility. The #CDMO's expansion includes increased storage for ultra-low temperatures and more than 60% growth in cold chain #packaging capacity. #GMP.

#BioSpring to build large-scale #nucleicacid active #pharmaceutical ingredients site in #Germany. The site will produce APIs at commercial scale and include solvent storage and quality control labs. #oligonucleotide #contractmanufacturing #RNA #DNA #GMP.

#StevanatoGroup's #Indiana #manufacturing site is poised for #syringe production boost. After touring the Fishers facility, #WilliamBlair analysts say demand is robust for #syringes with a sequential utilization ramp-up in coming quarters. #biologics.

#EU fines #Alchem $525,000 for #pricefixing of key active #pharmaceutical ingredient. The #EuropeanCommission investigation revealed the India-based manufacturer coordinated SNBB pricing and shared sensitive data over a 12-year span. #regulatory #cartel.

#NovoNordisk's $2.3 billion investment in #fillfinish factory takes on national importance in #Italy. Italian authorities have appointed a special commissioner to ensure the former Catalent facility near Rome is speedily upgraded. #pharmamanufacturing.

#Catalent CEO #AlessandroMaselli sees a bright future for the global #CDMO under #NovoHoldings' ownership. In this Q&A, Maselli discusses Catalent's capabilities and areas of investment, as it expands offerings to best serve #biopharma customers. #CEOs #AI.

#WuXiXDCCayman completes construction of #bioconjugates #manufacturing site in #Singapore. The 25,000-square-meter site at Tuas Biomedical Park is slated to start operations by the end of 2025 and #GMP manufacturing in early 2026. #WuXiXDC #CRDMO.

#PiramalPharma has broken ground as part of a $90 million expansion at two U.S. facilities. The #CDMO is expanding #manufacturing sites in Lexington, Kentucky, and Riverview, Michigan, which are essential to its integrated #AntibodyDrugConjugate offering.