Evolution in Biologic Drug Products – Need for Administration of High Viscosities
Biologic drug products are not new – their development began decades ago; the first monoclonal antibody was commercialized in 1986.  With the increasing availability of genetic information, and better understanding of subcellular cascades and disease processes, the number of biologic drug products available has increased substantially in response to an exponential growth in targets. 
Biologic drug products can be composed of sugars, proteins, nucleic acids or combinations thereof – also they may be composed of living entities such as cells and tissues. Frequently, they involve large, complex molecules  and are often administered parenterally .
A critical concern in formulation development is the relationship between API concentration and drug product viscosity. Large molecules result in high viscosities, but high viscosity drug products cannot be injected easily. As a result, dilution is performed, which may result in large dosage volumes.
Delivery of large volumes is a challenge. A way to address this is with pre-programmable, easy-to-use, wearable injectors – such as the West SmartDose® drug delivery platform – that can deliver larger volumes at a pre-programmed delivery time. West is committed to safe, efficient delivery of drug products to patients.
SmartDose® is a registered trademark of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceutical Services, Inc.
West markets SmartDose® as a multi-component system only. Final assembly of the prefilled component is completed by the pharmaceutical company.
 Dawn M. Ecker, Susan Dana Jones, and Howard L. Levine. The therapeutic monoclonal antibody market, MABs, Jan-Feb 2015, 7(1), 9-14 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4622599/
 Thomas Morrow and Linda Hull Felcone. Defining the difference: What Makes Biologics Unique, Biotechnol Healthc, Sep 2004, 1(4), 24-26, 28-29 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3564302/
 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION, What are “Biologics” Questions and Answers: What is a biological product? How do biological products differ from conventional drugs?, August 5, 2015 https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm133077.htm
 S.W. Chung, T.A. Hil-lal, Y. Byun. Strategies for non-invasive delivery of biologics, J Drug Target, 2012, 20(6), 481–501, https://www.ncbi.nlm.nih.gov/pubmed/22632037