Biologics are expected to make up more than half of the world’s top 100 selling drugs by 2020 , and an increasing number of large pharmaceutical companies are shifting their focus to developing biopharmaceutical formulations. Because biologics are large, complex molecules, a monoclonal antibody may consist of more than 1,000 amino acids and weigh around 150,000 g/mol (or 150 kDa). This means that biologic formulations are often viscous and high in concentrations. While adding diluents can facilitate better syringeability, it leads to higher volumes and thereby requires larger devices that can accommodate a bigger pre-filled syringe and a more powerful delivery mechanism.
On the one hand, growing competition in the biologics space has led to an increased demand for preconfigured auto injector technologies that offer shorter development lead-times to clinic and to market. On the other, the rising popularity of large molecule drugs has also resulted in an increased interest in disposable auto injectors that can carry and deliver doses above 1mL.
THE RISING POPULARITY OF LARGE MOLECULE DRUGS HAS RESULTED IN AN INCREASED INTEREST IN DISPOSABLE AUTO INJECTORS THAT CAN CARRY AND DELIVER DOSES ABOVE 1ML.
Moreover, as more and more patients prefer less frequent administrations of their existing treatments, the industry has also seen a growing demand for larger-capacity devices that can deliver higher drug dosages per injection. “The larger volume allows new drugs to be delivered in auto injectors as well as launched products to be dosed less frequently,” says Magnus Fastmarken, global marketing director of SHL Group.
Responding to these trends, SHL created Molly® 2.25, a high-volume variation of its classic Molly®, a preconfigured auto injector technology developed to minimize customer investments and speed up development timelines. It was first introduced in 2010 for 1mL pre-filled syringes in both the rigid and flexible needle shield formats.
Molly® 2.25 is a high-volume variation of the SHL’s preconfigured Molly® auto injector
Molly® 2.25 offers the same development framework while supporting injection volumes in the 1-2.25mL range. Inheriting the 1mL Molly®’s compact design, the larger variation is handy, lightweight and just slightly larger than its predecessor. It is also designed with an ergonomic anti-roll cap that facilitates easier removal, giving patients more confidence when handling the device.
Building automated assembly and testing equipment in-house also allows developers to shorten the product development timelines.
Supported by SHL’s vast and comprehensive range of in-house capabilities, including robust automation equipment for assembly and testing, as well as vertically integrated services in final assembly, labelling and packaging, the 1mL Molly® has already been commercialized in a wide range of shapes and colors within several therapeutic areas. Fastmarken notes that the company is also looking forward to the market introduction of its first high-volume drug delivery projects based on the preconfigured Molly® 2.25 auto injector technology. The first drug product being built into a high-volume Molly® auto injector has already been approved by the FDA in the pre-filled syringe format.
Fastmarken adds, "Combining our core expertise in designing auto injectors with our broad range of in-house expertise and services, SHL continues to lead the market with innovative drug delivery solutions for the pharmaceutical and biopharmaceutical industries."
Now, with the commercialization of the first 2.25mL variations, SHL has again proved that it took into consideration customer demands and patient needs, delivering faster development timelines and higher volume injections.
SHL Group is a world-leading solution provider in the design, development and manufacturing of advanced drug delivery devices. We also offer core competencies and services in the fields of medtech and patient care solutions. With over 4,000 employees worldwide and locations in Taiwan, Switzerland, Sweden, China and the US, our experienced engineers and designers develop product enhancements as well as breakthrough drug delivery and patient care solutions for pharma and biotech clients globally. Significant investment in R&D has enhanced our broad pipeline of next-generation drug delivery systems that support ongoing innovations in drug development and digital healthcare. This includes advanced reusable and disposable injectors that can accommodate high volume and high viscosities and can be enhanced through digital implementations.
- Clinical Leader. “Critical Considerations for High Viscosity/High Volume Drug Delivery Devices.”
- Ralf Otto, Alberto Santagostino, and Ulf Schrader. “Rapid growth in biopharma: Challenges and opportunities.” McKinsey & Company.
- Bayer. “Small and Large Molecules.”