Table 1.
Formulation and Device Technologies Enabling SC Delivery of High-Dose Biologics
| Type | Technology (Manufacturer) | Key Features | References |
|---|---|---|---|
| Formulation technologies that form fluid suspensions | XerijectTM (Xeris Pharmaceuticals, Chicago, IL, USA) | Uses specialized particle engineering techniques to create paste formulations | [40] |
| ElektrojectTM (Elektrofi, Boston, MA, USA) | Uses a gentle atomization/desiccation procedure to create microparticles with high protein loading with improved long term physical and chemical stability | [41] | |
| MicroglassificationTM (Lindy Biosciences, Durham, NC, USA) | Enables the dehydration of proteins or other biologics into stable, spherical microbeads | [42] | |
| Crystalomics® (Althea/Ajinomoto Bio-Pharma, San Diego, CA, USA) | Creates crystal suspensions | [43] | |
| Formulation technologies that minimize intermolecular interactions in solution to reduce viscosity of high-concentration formulations | ArestatTM (Arecor, Little Chesterford, UK) | Uses buffering agents and formulation excipients to improve protein/peptide stability in aqueous solutions | [44] |
| BioChaperone® (Adocia, Lyon, France) | Forms a molecular complex with therapeutic proteins of interest that improves their solubility and stability | [45] | |
| EXCELSETM (ExcelseBio, Thousand Oaks, CA, USA) | Uses a customized amino acid blend that coats key molecular regions responsible for the increase in viscosity, thereby preventing clumping and protein instability | [46] | |
| Devices that allow for SC injection of high viscosity formulations | Safelia® autoinjector (Nemera, La Verpillière, France) | Uses a cam system to manage the increased spring force to deliver 1 or 2.25 mL fluids of up to 1000 cP viscosity | [47] |
| Autoject® Visco autoinjector (Owen Mumford, Oxfordshire, UK) | Uses a velocity regulator to minimize shock and noise | [48,49] | |
| YpsoMate 2.25 Pro autoinjector (Ypsomed, Burgdorf, Switzerland) | Uses a drive system with constant force to deliver up to 2.25 mL of up to 50 cP viscosity | [50] | |
| Rotaject® autoinjector (SHL Group, Zug, Switzerland) | Uses torsion springs and regulators to control the application of force over time to deliver 1 or 2.25 mL fluids of up to several 100 cP viscosity | [51] | |
| Vapoursoft® powered autoinjectors (Bespak, King’s Lynn, UK) | Uses the expansion of a compressed gas to replace spring force and minimize the impact on primary containers to deliver 1 or 2.25 mL | [52] | |
| AutoTouch™ autoinjector (Amgen, Thousand Oaks, CA, USA) | Uses electromechanical motors to finely control the application of force over time and tailor injection rate to patient preference | [53,54] | |
| ArQ®-Bios (Oval Medical Technologies, Cambridge, UK) | Uses cyclo-olefin co-polymer containers that are strong enough to withstand the stresses of delivering 1 mL of a 1000 cP fluid in 5 seconds | [55] |