10.10.18 -- Outsourcing On The Cheap To China?

I’ve reached out to biopharma companies for answers to this question: “Why does your organization outsource so much drug development and manufacturing to China?” Prompted by President Trump’s remarks on the subject on October 1st, seems like a good time to present some of those initial industry responses, and further analysis of what we are facing.

You just received the urgent call, email, or text that a batch of commercial product made by your company’s outsourced supply chain has failed and, at first glance, the failure isn’t due to an analytical error. What do you do next?

Quality metrics, quality culture, and data integrity are among the current and emerging topics of interest to the pharmaceutical industry of particular concern to both the industry and regulatory authorities. To understand how these three topics relate to each other, it is important to understand some of the history that led up to today’s environment, where quality metrics, quality culture, and data integrity come together in establishing current global regulatory expectations.

In the rush to market, be aware of these critical missteps that can occur during the early development phases in order to avoid major challenges later during commercial API scale-up.

Having a solid understanding of the most common API challenges can help avoid development delays, rework, or outright failure.

Manufacturing viral vector-based therapies, such as vaccines and gene and cell therapies, is complex, but a new manufacturing solution helps solve challenges.

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