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by: Yusuf O. Oni

Reports honi-headshotave indicated that the burgeoning biologics drug market is expected to grow to $251 billion by 2018 and $900 billion by 2024. However, as these large molecules become increasingly more complex, the need for technologies to enable their efficient delivery are as essential as ever. These technologies must address multiple hurdles including regulatory, quality, formulation, and manufacturing challenges. A recent article highlights some of the current industrial solutions available in the area of wearables or bolus injectors. West’s Smart Dose, Insulet’s OmniPod, and SteadyMed’s PatchPump are three such examples.

Moreover, the delivery of these biologics such as monoclonal antibodies (mAbs) and antibody drug conjugates usually require large masses to be injected, which implies an increase in injection volume and/or an increase in the drug concentration. As a result, high volume and high viscosity represent two of the principal challenges that must be overcome with new delivery strategies.

The potential proshutterstock_431832187-1blems attributable to each of these challenges have been well described. Generally, pain and injection time management become a concern for such therapeutic deliveries. Furthermore, retro-fitting aseptic filling lines that have been built for 1 mL syringes to accommodate higher volumes can quickly become a manufacturer’s nightmare; whereas, high viscosities due to increased drug concentrations would demand devices that can withstand elevated injection forces.

Coupled with the usual challenges of quality concerns, strict regulatory requirements, drug product-container interactions, other manufacturing complexities, lyophilization, and especially the potential future theme of combination therapies, the biotech industry is inundated with a lot of problems to solve.

Clearly, we are not there yet.

So where do we go from here? Specific conversations relating to high volume and high viscosity drug delivery need to begin. Please join me and my colleagues at the 2016 AAPS Annual Meeting and Exposition to discuss the current innovations in parenteral packaging to enable high volume and high viscosity drug delivery with perspectives that scan the regulatory, manufacturing, and industrial landscapes.

Dr. Oni is a Principal Engineer at Bristol-Myers Squibb Company where he is involved in all aspects of primary packaging & device development in the parenteral product development space. He also has professional background in materials selection and characterization.  Dr. Oni currently serves as an Adjunct Faculty at New Jersey Institute of Technology.