Company insight
Going modular for faster development
As pharma companies race to launch new autoinjectors amidst soaring demand for at-home treatment, device manufacturers like SHL Medical are turning to modular platform technologies – for both devices and manufacturing machinery – to shorten lead times and maximise efficiency.
popularity of at-home self-injection, demand for combination products is surging. For pharma companies, getting a drug to market on time, on budget, and on spec hinges on selecting the optimal manufacturing method and partner.
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Platform-based manufacturing is central to the proliferation of combination products, in which a core, standardised autoinjector device serves as the basis for a family of products. However, the competition to launch biosimilar drugs requires increasingly customised designs to meet drug, container, branding and patient specifications. Furthermore, addressing changing production demands and lifecycle management necessitates flexibility beyond the scope of traditional platform products.
A modular platform device technology
This flexibility can be achieved with a modular platform approach, in which a platform product is combined with interchangeable modules of different sizes or functionality to create unique variations according to branding and usability needs. These pre-tested modules support standardisation, repeatability and customisation, resulting in shorter development timelines and reduced costs. SHL Medical’s Molly 1.0ml and 2.25mL autoinjectors, for example, include front and rear subassemblies, each with five or six intricately designed parts. Customisation options include the cap and needle cover colour, cap shape and viewing window size. Molly’s success underscores the effectiveness of this modular approach, with 17 distinctive combination product projects approved across various disease areas since its launch in 2010.
ith rises in chronic diseases, the increasing use of biologics and biosimilars, and the growing
SHL Medical’s modular equipment strategy supports scalable testing, assembly and final assembly throughout an autoinjector project’s lifecycle.
Modular machinery
Applying modularity to autoinjector assembly and testing equipment offers similar competitive advantages in customisation and scalability. To ensure high-quality, high-volume output, SHL has adopted a modular design strategy for its equipment base. This strategy features a standardised platform that supports a range of manual, semi-automatic and fully automatic machine systems for autoinjector assembly, final assembly and final device testing. Because this infrastructure is modular and repeatable, it can be adjusted to process a mix of different products at speed, on a flexible scale and with consistent quality, thereby minimising costs, risks and lead times.
In addition to several assembly machines, SHL also introduced a fully automatic modular testing machine (modular FATM) in 2021; designed for various injection devices, it offers mix-and-match testing, such as to verify cap removal force, injection activation force and injection functionality.
Bringing it together
Final assembly – in which the autoinjector’s subassemblies are combined with the drug
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and its primary container – is particularly complex. A comprehensive understanding of a device’s design is required to develop the final assembly sequence and build the necessary equipment.
As an end-to-end solutions provider, SHL also designs and manufactures such machinery used in final assembly. This offers unique flexibility and benefits for its pharma partners, who may have SHL plan and perform all the final assembly processes. In such cases, SHL’s machine experts work with their own project teams to ensure smooth design transfer and execution of the final assembly, facilitated by the continuity, consistency and feedback made possible by having all relevant infrastructure and expertise in-house. SHL’s success showcases the power of flexible modular design for both devices and machinery. When complemented by the advantages of a vertically integrated solutions provider with the capacity to manufacture the machinery, too, modular platform technologies give pharmaceutical companies a streamlined, reliable means of getting their products to market. ●
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