From procurement and quality control of raw materials to distribution and safety of final products, the supply chain provides a framework within which process development, manufacturing, testing, and sales of biopharmaceuticals can function. This featured report includes articles from both sides of the story: from RoosterBio on stem cells as raw materials and from Biogen on final product stability.
Introduction: The Ins and Outs of Market Demand
BioProcess International’s Editor in Chief, Anne Montgomery describes the industry forces shaping today’s supply-chain management and what supply-chain managers face.
Standardizing Human MSCs As Critical Raw Materials in Cell Therapy Products: Streamlining Clinical Translation
In “Standardizing Human MSCs As Critical Raw Materials in Cell therapy Products: Streamlining Clinical Translation,” Majumder, Olson, and Rowley address what industry analysts have feared would be a major impediment to the success of cell therapies at manufacturing scales: the difficulty of producing the predicted trillions of cells needed for such therapies while (critically) reducing the final costs borne by patients and insurers. Their company, RoosterBio, seeks to disrupt this industry segment by making cells readily available to developers for expansion into multiple product types and classes, thereby eliminating a large portion of the costs of sourcing and internal development. In BPI’s main issue this month, a complementary article details how RoosterBio developed its platform technology.
Spray Freeze-Drying Technology: Enabling Flexibility of Supply Chain and Drug-Product Presentation for Biologics
In “Spray Freeze-Drying Technology: Enabling Flexibility of Supply Chain and Drug-Product Presentation for Biologics,” Lowe, Mehta, and Gupta describe Biogen’s strategy to alleviate risks associated with the need for a complex cold-chain infrastructure by manufacturing biopharmaceutical drug substances as bulk powders. Through a new alternative to the old standby procedure of lyophilization (spray freeze-drying), the potential for long-term, room-temperature stability in dry-powder form could facilitate commercial manufacturing, especially into developing markets.