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Pharmaceutical Manufacturing and Packing Sourcer

Supporting Parenteral Product Development

Conventional practice dictates that parenteral product development proceeds on two parallel paths – the pharmaceutical partner develops the formulation, while the device company develops the delivery technology.

While this convention has served the industry relatively well over the years, there is now, more than ever, an imperative to speed bench-to-market time, while mitigating risk and reducing cost in the development cycle.

In this article, we will explore the philosophy of partnerships working in the development of a parenteral drug/device interface, considering the benefits of adopting a parallel approach in areas such as process intimacy.

We will then review the developments that device partners have made in defining and refining an integrated process development strategy.

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As Director of Process Development at SHL Medical located in the US, Dr Amy Hartl oversees the operations, testing, and statistical analyses that are crucial for the device design transfer phase of auto-injector product development. The process development team develops, validates, and transfers device testing, final assembly, device labelling, final packaging, and serialisation processes. In parallel, her team also develops strategies for increasing and optimising the site’s capacity by implementing high-speed equipment and leaning out existing processes. Dr Hartl has been working at SHL since 2016. Prior to joining the medical device industry, Dr Hartl taught Statistics and Experimental Design courses at Florida Atlantic University where she also obtained her PhD in Experimental Psychology.

Markus Goldinger is currently the Senior Director of Process Development at SHL Medical located in Taiwan. He joined SHL in 2017 as Senior Manager in Process Development, where he was responsible for project engineering, moulding process development, and assembly process development. In late 2018 he also took over component development including metal, packaging, and printing process development. Before his current role, it was in early 2019 when Markus took directorship of process development. In this position, Markus successfully restructured and guided his team towards SHL Medical’s high-volume production strategy.
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Dr Amy Hartl
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Markus Goldinger
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