The recent survey by the Economist Intelligence Unit asked biopharma execs about their hopes and concerns for the future of the industry. The results showed there was great excitement about the emergence of new markets and novel therapies, but this was tempered by worry over the complex maze of regulatory requirements. We spoke with Frithjof Holtz, Director of Advocacy and Surveillance for MilliporeSigma, to explore the interplay of emerging markets and regulatory harmonization.
Whether these proteins are produced by recombinant DNA technology or extracted from sources such as plasma, they need to be highly purified — and the purification process must satisfy a variety of regulations.
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.
whether you’re building a plant for a small molecule drug or a biologic, you need to be able to do so faster and in a more agile manner than ever before.
How a customer focused mission to boost single-use assembly product quality and supply security led to the Mobius® MyWay Program and a manufacturing site transformation.
In addition to having the optimal cell line and process, it is crucial to have the optimal cell culture medium and feed to maximize performance potential.
“Closed system filling” is a new set of processing controls for a sterile filling process that eliminates potential microbiological contamination from environmental and operator sources.
Understand the new technologies and methodologies that are emerging for both producing and testing biopharmaceuticals as the industry is entering a new era of viral safety assurance.
When customers consolidate their supply chain and use one vendor from drug substance through drug product, it can transform the entire drug development process into a more efficient system.
By recognizing the limitations of today’s production processes, the industry may be able to overcome the challenges, complexity, and high cost of manufacturing vaccines and viral vector-based therapies.
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