Over decades, the challenges of drug delivery have continually been met with innovation. Problems have been met with solutions.
Take the prefillable syringe. These devices were first introduced in the Second World War as a mechanism for delivering injections in battlefield settings – an innovative answer to the question of how to administer medication with speed, sterility and dosing accuracy. While the fundamental premise has remained the same, today prefilled syringes have grown in significance and prevalence, with advances in design and materials science ensuring they have a crucial role in the delivery of drugs, including sensitive biologics, through their ability to preserve the drug’s quality, efficacy and safety; deliver highly targeted doses; and support self-administration.
While prefillable syringes might have provided the means to simplify drug delivery, they are part of a highly complex, strongly regulated, and traditionally componentdriven development program. Being regulated as combination products adds an additional layer of complexity. From design and development through part selection, design and development verification and manufacturing, there are many critical, often contradictory considerations that must be taken into account to simultaneously ensure the quality, efficacy and safety of the drug within a safe, functional and usable device. The success of these development programs is undoubtedly testament to the sector’s problem-solving capabilities, but they also serve to highlight the absence of more efficient ‘top down’, integrated and holistic solutions.
The issue at the heart of the matter is that while prefillable syringes present as systems, they are, in fact, as of now a collection of multiple components combined to form a coherent whole. And given the highly regulated nature of these combination products, it is therefore quite typical for development to be a lengthy and highly complex process. In a market increasingly populated by emerging biotechnology companies, the process of taking a molecule from formulation to the market as a final combination product can be a daunting one, beset with pressures in a variety of areas.
Currently, these issues are addressed through engagement with external consultancies and a disaggregated network of supply chain partners. The onus is on the drug originator to co-ordinate these moving parts and bring various strands of development together. Indeed, the sourcing and procurement of components demands detailed knowledge of the quality target product profile (QTPP), the critical quality attributes (CQAs) and other information needed to create robust design and development inputs as guided by the Quality Guidelines 8 and 9 of the Internation Council of Harmonization (ICH Q8 and Q9).1 Current Good Manufacturing Practice (cGMP) regulations across global territories, which include Part 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals) and Part 820 (Quality Management System Regulation) of Title 21 of the Code of Federal Regulations in the United States (21 CFR Part 211 & 820) and the GMP guidelines in the European Union (EU GMP).
