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From Logistics to Lifecycle: Building Advanced Therapy Supply Chains that Scale

May 27, 2026
As cell and gene therapies approach broader commercialization, the supply chain landscape is undergoing significant transformation. The logistics function, traditionally seen as a support role, is now integral to the therapy itself, where factors such as timing, temperature control, and coordination are critical to treatment success. The shift necessitates a reevaluation of how supply chains…

The Hidden Complexity of Inhalation Drug Development

May 27, 2026
Pulmonary drug delivery is expanding beyond traditional indications such as asthma and chronic obstructive pulmonary disease (COPD), with the inhalable drugs sector projected to grow from approximately $36 billion in 2023 to nearly $60 billion by 2030. This growth is driven by innovative therapies and delivery methods, particularly in dry powder systems and other inhaled…

FDA’s leadership void leaves biotech with renewed ‘uncertainty’

May 27, 2026
Marty Makary’s resignation leaves the FDA with temporary directors in three top positions, creating a leadership vacuum that could hinder decision-making processes. This shift comes at a critical time when the agency is navigating complex regulatory landscapes and implementing newly instituted policies aimed at streamlining biotech approvals. The absence of stable leadership raises concerns among…

Cellares and ProTgen Automate Manufacturing of Progenitor T-Cell Therapy for Blood Cancer

May 26, 2026
Cellares, an Integrated Development and Manufacturing Organization (IDMO), has partnered with ProTgen to automate the manufacturing and quality control processes for ProT-096, a personalized progenitor T-cell therapy targeting patients with refractory leukemia and other hematologic malignancies. This collaboration leverages Cellares’ advanced Cell Shuttle and Cell Q platforms, which streamline production while providing essential regulatory support…

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