Pediatric drug development requires a formulation designed to fit the specific needs of that patient population. Not considering these requirements early enough could add significant delays.
Small and emerging companies face significant challenges in today’s market. This calls for an alternative solution to help them achieve success.
Current state-of-the-art continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products including monoclonal antibodies, recombinant proteins, and other biological modalities. Though upstream fed batch and perfusion bioreactors unit processes are relatively mature, downstream process unit operations are less mature. In this case study, Catalent compared the productivity of purifications running in batch versus continuous mode.
Review practical solutions for “small changes” in the clinical supply chain that can wreak havoc if not planned for in advance.
Concerns about leachables were expected to restrict adoption of single-use systems. This case study shows how far they’ve come.
Oncolytic viruses constitute a new promising therapeutic approach for treatment of cancer. Here’s an example of a scalable, end-to-end process for oncolytic adenovirus production using modern tools and technologies.
This application note examines these aspects of using sodium hydroxide as a cleaning and sanitizing agent.
While the potential for advanced therapies to provide curative treatments to patients around the world is very exciting, the pricing strategies and reimbursement models to support this innovation are quite complicated. In this article, I’ll explore the cost vs. price paradigm, through a supply chain lens, highlighting hidden costs and their impact on reimbursement potential.
As novel medicines become a larger part of the industry's portfolio, it is critical you secure a supply chain and manufacturing processes that produce drugs in a reliable, cost-effective way.
Learn how a structured 3-step approach can help overcome the challenge of molecular characterization and a limited budget.
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