WuXi AppTec Archives - Medical Design Sourcing

5 critical questions medical device manufacturers must ask potential lab testing partners

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You can learn a lot about a potential medical device testing partner by asking about experience, capacity, testing approaches, communication and pre-submission meetings.

By Sandi Schaible, WuXi AppTec Medical Device Testing

Selecting a laboratory testing partner can be tricky — it goes well beyond mere technical capabilities.

Knowing the right questions to ask when choosing a testing partner will help device manufacturers build strong relationships, protect timelines, and deliver safe, effective medical devices.

1. What experience do you have in medical device testing, specifically in the areas of biocompatibility, chemical characterization and toxicological risk assessment?

Asking about a potential partner’s experience in the fundamental areas of preclinical medical device testing allows manufacturers to quickly determine if the potential partner can handle a p…

How MetID studies can improve safety and efficacy in PROTAC drugs

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Most drugs undergo some degree of biotransformation after being administered. This metabolism process allows a drug’s active pharmaceutical ingredient (API) to achieve its desired effect or be eliminated. Metabolism also creates innumerable metabolites that can stimulate or inhibit enzymes, cultivate a chemical reaction or defend against other organisms in vivo. For these reasons, metabolites that exceed 10% of total exposures to drug-related components in humans must be identified and characterized through targeted toxicological studies called metabolite identification (“MetID”) studies.

In vitro MetID assays are simple, rapid and can achieve high throughput. They can also be used to predict in vivo metabolism, thereby saving experimental test species. In vivo, MetID studies on animal bile, urine and feces can provide information on the drug’s metabolic an…

5 questions drug developers need to ask when vetting laboratory testing partners

Laboratory image courtesy of Pexels.

Drug development is a hyper-competitive industry, and pharmaceutical developers are increasingly turning to outsourced laboratory testing partners to gain an edge. Choosing the right partner can maximize efficiency and play a critical role in gaining regulatory approval quickly.

Still, outsourcing critical research comes with an element of risk. It is crucial to vet research partners to ensure rigorous and reliable work.

Additional factors need to be considered when working with a laboratory testing partner in the COVID era. Supply chain disruptions are impacting research laboratories around the globe, delaying trials and causing drug development timelines to balloon. But the right laboratory testing partner can help set expectations and mitigate many potential obstacles. Selecting a partner that fits your organization’s goals can mean a fruitful and profitab…

3 questions medical device manufacturers should ask before ISO 10993-17 updates

The upcoming publication of ISO 10993-17 will support the latest ISO 10993 expectations already in place. Gain insights into what this standard will mean to the evaluation process and how to prepare in advance.

Sherry Parker, WuXi AppTec Medical Device Testing

[Image from Pixabay]

Following ISO 10993-1, the lens of medical device biological safety evaluation changed to a risk management process, impacting how manufacturers prepare their medical devices for submission.

The newest version of ISO 10993-17 is approaching publication. These revisions expand current guidance on establishing limits for leachable substances to assess the toxicological risk of medical device chemical constituents. The changes allow for a more consistent evaluation and will likely lead to a more device-specific approach to subsequent biological safety evaluations.

While the ISO 10993-17 guidance document is still in the dra…