Grindeks Group has announced the introduction of CDMO and out-licensing services, marking a shift in its business development strategy under its new leadership. The company stated that although it has focused on its own brand portfolio over the past decade,
Piramal Pharma Solutions has announced the completion of its organisation-wide effort to comply with global requirements for nitrosamine impurities in pharmaceuticals. Nitrosamines are unintended carcinogenic byproducts, and regulatory expectations for nitrosamine drug substance-related impurities have expanded in recent years. The
medac CDMO has announced a partnership with UroGen Pharma to support the development and supply chain of UGN-103, using medac’s licensed mitomycin formulation and manufacturing services. The collaboration is aimed at advancing the candidate therapy and enabling reliable access to
eXmoor Pharma and the Royal Free London NHS Foundation Trust, through its Cell and Vector Innovation Centre (CVIC), have formed a strategic collaboration to strengthen the UK’s cell and gene therapy development and manufacturing ecosystem. The agreement links CVIC’s early-phase
Microsize has signed an agreement to acquire MicroMacinazione (Mic Mac), a dedicated micronisation facility in Monteggio, Switzerland, from Lonza. The deal follows Microsize’s acquisition of Lonza’s Quakertown, Pennsylvania site in 2022 and forms part of a broader strategy to build
Made Scientific, Inc. and Cellergy Therapeutics Ltd. have entered a manufacturing partnership to support the advancement of Cellergy’s mitochondrial therapy CLG-001. The agreement aims to prepare the treatment for first-in-human clinical studies. CLG-001 will be manufactured for clinical use under
BioDlink and Lepu Biopharma have announced the market launch of MEIYOUHENG® (Becotatug Vedotin injection), described as the world’s first EGFR-targeting antibody-drug conjugate. The product is also the first ADC fully manufactured by a CDMO to enter the market in China.
Recipharm Advanced Bio and Infant Bacterial Therapeutics AB (IBT) have initiated Process Performance Qualification for IBT’s lead product, IBP-9414. The programme will take place at Recipharm’s microbial manufacturing facility in Cuxhaven, Germany, and marks a key milestone on the pathway
TAPI has entered a new strategic partnership with Antheia aimed at supporting the commercialisation of Antheia’s biosynthetic key starting materials and active pharmaceutical ingredients. Under the agreement, Antheia will use TAPI’s fermentation capabilities and European manufacturing facilities to scale its
AGC Biologics has entered a new manufacturing agreement with AAVantgarde to support the production of two investigational gene therapies for inherited eye conditions. The announcement follows AAVantgarde’s recent Series B financing and marks AGC Biologics’ latest expansion in the adeno-associated
