An article by SHL Group was recently featured in InPharm’s Manufacturing & Production Guide. Written by marketing director Steven Kaufman, the article was on the topic ‘Insight into the Manufcturing of an Auto Injectory’:
As the number of biologics coming to market continues to grow, the demand for drug delivery devices such as the autoinjector, which enhances patient compliance, also continues to experience significant growth. While the overall design (such as delivery mechanisms and ergonomic features) of the autoinjector is key to helping empower patients to administer therapies properly and safely in the comfort of their own home, the manufacturing processes required to make these devices are also crucial.
Biopharmaceutical companies need to understand what implications manufacturing capabilities can have on their final product and choose a device partner accordingly. For example, possessing core manufacturing capabilities in-house versus outsourcing can affect a device’s time-to-market, quality during mass production, IP protection and much more.
An autoinjector can have several plastic components, ranging from six to over 20 components, depending on its design and functionality and will require capabilities such as tooling, molding, metrology, automation and assembly to develop the final device. As a result, biopharmaceutical companies should consider partnering with a device manufacturer that can offer this range of core capabilities in-house to consolidate key development stages and allow for faster communication and support.
Tooling and molding
A robust and producible design will always be the key factor in determining the quality of an autoinjectors’ components. While no tool in the world can produce a quality product without a good design, a tool will determine the quality of its plastic parts and is the heart of the injection molding process.
However, developing a good tool requires significant investment and time and can quickly become one of the major bottlenecks when manufacturing an auto injector if not properly managed. The manufacturing of autoinjector parts not only involves high precision but is most often produced in high volumes. As such, high precision injection molding tools, multi-cavitation tooling, hot runner systems and precision molding machines are just some examples of capabilities to ensure precision, scalability and capacity.
With response time crucial to project timelines, biopharmaceutical companies can consider seeking a device manufacturer partner that has an in-house tooling and molding center and avoid potential delays accrued when communicating with a third-party vendor.
Keeping tooling and molding in-house allows a device manufacturer to communicate designs to required tools more accurately and efficiently and at the same time allows the biopharmaceutical company to protect associated intellectual properties within one device partner. An established in-house tooling center with experienced engineers also demonstrates a device company’s commitment to investing in quality consistency as this allows for supervision of projects to be performed even more frequently and closely.
Automation and assembly
During the development of an autoinjector, various verification tests will be carried out to ensure the device meets its input requirements. However, to perform these tests, a range of custom-made fixtures, testing and assembly machines will be required. A device manufacturer that has automation capabilities in-house can provide biopharmaceutical customers shorter lead times as the availability of customised machines in-house allows for testing to take place once the corresponding designs and tooling are ready.
With each autoinjector consisting of different components and mechanisms, customised assembly machines are required. These machines should be designed to be robust enough to ramp up for high volume projects but also offer repeatability to ensure quality. By designing and manufacturing such machines in-house, the device manufacturer can work closely with the biopharmaceutical customers to develop assembly operations best suited to streamline processes and meet forecasted timelines.
Some common assembly solutions include semi and/or fully automatic assembly machines for both sub assembly of components and final assembly of devices. In addition, automation experts from the device company can provide technical support to quickly adjust assembly lines depending on project scale. Alternatively, if automation was completely outsourced, the required design transfers and potential miscommunications that may occur can create additional risks and complexity.
The therapeutic nature of the autoinjector requires not only the precise inspection of its plastic components but also associated equipment parts such as injection molding tools and CNC processed metal parts. As a result, a range of metrology machines that can perform detailed measurements (such as image, contact and laser) should be made readily available throughout the manufacturing of the autoinjector to eliminate any chance for error and to ensure that all measurements are accurate, repeatable and reproducible.
It is important that a biopharmaceutical company that wants to develop an autoinjector device understand the manufacturing processes involved, key capabilities required and the implications of in-house capabilities versus outsourcing capabilities. This will assist them in choosing a device manufacturing partner to best suit their business model.