SHL is officially introducing the company’s first white paper on the topic of ‘Autoinjectors: From Planning to Launch’ with the goal of sharing with readers insights on how to prepare for the overall development process from different perspectives, including design, regulatory and manufacturing.
The paper does not have any promotional content and focuses on sharing with those interested in starting an autoinjector project what to prepare for and challenges to look out for. As a preview, here is the paper’s introduction:
Looking at the rising trend towards self-administration therapies, injectable drug delivery devices such as pen injectors, autoinjectors and needle free injectors show a significant growth potential in the near future.
In 2010, the pen systems and autoinjectors market was estimated to be worth over $0.58bn, a growth of 8%-10% from previous years. It is estimated that the market will continue to grow steadily between 10%-15% over the forecast period. It will reach $0.87bn in 2013 and $1.07bn in 2015.
Driven by the corresponding industry demands, biopharmaceutical companies have since introduced a large range of solutions for delivery of injectable drugs and continue to push for improvements in every aspect. In fact, industry analysts have estimated that over 30% of all new product submissions to the FDA are combination products (Richter, 2011). Of these, the autoinjector is one of the fastest emerging drug delivery solutions that enhance patient experience and compliance by allowing them to safely self-administer medications at home. Aside from patient benefits, the resulting reduced number of clinic visits can help lower cost for health authorities by removing burden on nurses/healthcare providers (HCPs) to deliver face to face treatments. The various ergonomic designs and safety mechanisms built into the autoinjector also help address patient dexterity concerns and minimise the possibility of needle-stick injuries for HCPs assisting with the delivery.
While the autoinjector is now often considered by many biopharmaceutical companies to be a suitable device to commercially launch their therapeutic drugs in, to do so successfully requires detailed planning, combination product knowledge, regulatory awareness and, even more importantly, close collaboration with a carefully chosen device manufacturer. Unfortunately, biopharmaceutical and device companies have different product lifecycles and development processes which can lead to process gaps that are crucial to the overall project and can ultimately influence the product’s speed to market. It is therefore imperative that the biopharmaceutical company has a thorough understanding of all related processes, when and where to involve the device manufacturer, how to meet the corresponding regulatory demands for combination products, what core competencies to seek for and more.
This white paper focuses on assisting biopharmaceutical companies in taking a closer look at the development process of the secondary packaging of an autoinjector project from planning to launch and best practices on how to prepare for and address potential challenges along the way.
Click here to download this free white paper.