Grand River Aseptic Manufacturing (“GRAM”) needed commercial-scale, ultra-low temperature capacity units at -50°C delivered immediately to store forthcoming raw materials. A typical timeline for these solutions can run months, which did not meet GRAM’s needs. Working with FARRAR and creating cross-company project team enabled a typically long delivery cycle to be completed quickly and safely, with storage beginning 18 business days after the initial call (including a national holiday).
Matthew Van Gessel, Senior Manager of Capital Projects and Expansion at GRAM, stated, “In a matter of weeks, the FARRAR and GRAM teams went from placing the order to installation, qualification, release, and use of the -50°C freezers. The strength in partnership and culmination of responsive communication and coordination between the two teams resulted in the expedited outcome.
Roche gains exclusive global rights to ZW209, a DLL3×CD3×CD28 trispecific T-cell engager designed for CD28 co-stimulation. A phase 1 study in small cell lung cancer and other neuroendocrine tumors is underway.
A Treasury proposed rule would restrict certain US investments in biotechnology in China and other countries of concern, raising questions about how cross-border licensing and joint venture deals will be treated.
Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about the regulatory and manufacturing hurdles facing rare disease drug developers.
Rohit Tripathi, vice president of industry strategy, consumer packaged goods, and manufacturing at RELEX Solutions, explains where cold-chain planning still breaks down and why biopharma supply chain leaders should use AI to act on data sooner, with humans making the final call.
The FDA grants accelerated approval to Ultomiris for IgA nephropathy, Alcon acquires Neurotech and its MacTel cell therapy for $550 million, and BioNTech and Bristol Myers Squibb add Trodelvy to a phase 3 trial in triple-negative breast cancer.
BioNTech and Bristol Myers Squibb will replace chemotherapy with Gilead’s TROP2-directed ADC sacituzumab govitecan in the Phase 3 ROSETTA Breast-01 trial of PD-L1×VEGF-A bispecific pumitamig in PD-L1-low or -negative TNBC.