For years, traditional batch manufacturing has dominated the biopharma industry. Recently, however, continuous bioprocessing has gained traction among biopharma manufacturers.
In today’s evolving regulatory environment, supply chain transparency is a game-changing differentiator. Collaborating with manufacturing partners who have excellent supplier relationships and a deep understanding of materials can revolutionize the product development process.
The final stage in the manufacturing process for medical devices and life sciences products is sterilization. The FDA regulates four critical forms of sterilization: autoclave, dry heat, ethylene oxide, and irradiation. Irradiation includes both gamma-ray and electron beam methods.