ABSTRACT
Keywords: copaxone®, glatiramer acetate, relapsing-remitting multiple sclerosis (RRMS), nanotechnology, nanopharmaceutical, nanomedicine, nanodrug, subcutaneous delivery, non-biologic complex drug (NBCD), colloidal solution, follow-on biologics, biosimilar, nanosimilar, Abbreviated New Drug Application (ANDA), bioequivalence, biowaivers, immunogenicity, pharmacokinetics (PK), pharmacodynamics (PD), Food and Drug Administration (FDA), European Medicines Agency (EMA), patent, US Patent and Trademark Office (PTO), reference listed drug (RLD), surface plasmon-resonance (SPR), enhanced permeability and retention (EPR), dynamic light scattering (DLS), atomic force microscopy (AFM), cryogenic temperature transmission electron microscopy (Cryo-TEM), zeta potential, size exclusion chromatography, ion mobility mass spectrometry (IMMS), heat maps, immunomodulator, altered peptide ligand (APL), myelin basic protein (MBP), auto-reactive antibodies, anti-glatiramer acetate antibodies, hypersensitivity reactions Handbook of Clinical Nanomedicine: Nanoparticles, Imaging, Therapy, and Clinical Applications Edited by Raj Bawa, Gerald F. Audette, and Israel Rubinstein Copyright © 2016 Pan Stanford Publishing Pte. Ltd. ISBN 978-981-4669-20-7 (Hardcover), 978-981-4669-21-4 (eBook)
full swing as it continues to influence the pharmaceutical, device and biotechnology industries [1a, 1b, 2]. Nanomedicine is driven by collaborative research, patenting, commercialization, business development and technology transfer within diverse areas such as biomedical sciences, chemical engineering, biotechnology, physical sciences, and information technology.Although various “nano” terms, including “nanotechnology,” “nanopharmaceutical,” “nanodrug,” “nanotherapeutic,” “nano-material,” and “nanomedicine,” are widely used, there is confusion, disagreement and ambiguity regarding their definitions. In fact, there is no precise definition of nanotechnology as applied to pharmaceuticals or in reference to drug delivery. This haunts regulators, patent offices, policy-makers, drug formulation scientists, pharma executives, and legal professionals [3-9]. In particular, regulatory agencies and governmental entities such as US Food and Drug Administration (FDA), the European Medicines Agency (EMA), Environmental Protection Agency (EPA), Centers for Disease Control and Prevention (CDC), National Institute for Occupational Safety and Health (NIOSH), International Organization for Standardization (ISO) Technical Committee on Nanotechnology (ISO/TC229), ASTM International, the Organization for Economic Co-operation and Development (OECD) Working Party on Manufactured Nanomaterials (OECD WPMN) and the US Patent and Trademark Office (PTO) continue to grapple with this critical issue [3].The term nanotechnology is a bit misleading given that it is not one technology, but an umbrella term encompassing several technical/scientific fields, processes and properties at the nano/ micro scale [3, 6-9]. Various definitions of nanotechnology have sprung up over the years [3]. Some label it as the manipulation, precision placement, measurement, modeling or manufacture of matter in the sub-100 nm range [10], or in the 1-200 nm range [11, 12]. Some definitions omit a lower range, others refer to sizes in one, two or three dimensions while others require a size plus
special/unique property or vice versa. Others point to a size ranging from 1 to 1000 nm in both nanotechnology and pharmaceutical science [13-16]. This latter definition may be the most appropriate from a drug delivery perspective. The FDA, which has not adopted any “official” regulatory definition in this regard, now uses a loose definition for products that involve/employ nanotechnology and stretched the upper limit to 1000 nm. This underscores the urgency of establishing a uniform “nano” terminology. The need for an internationally agreed definition for key terms like nanotechnology, nanoscience, nanomedicine, nanobiotechnology, nanodrug, nanotherapeutic, nanopharmaceutical and nanomaterial is critical [3]. This is important for harmonized regulatory governance, accurate patent searching and prosecution, standardization of procedures, assays and manufacturing, quality control, safety assessment, and more.Given this backdrop, and the fact that there is no international scientifically accepted nomenclature or uniform regulatory definition pertaining to nanotechnology [6-9], the following widely-accepted definition unconstrained by an arbitrary size limitation has been previously proposed [3, 9]:
The design, characterization, production, and application of structures, devices, and systems by controlled manipulation of size and shape at the nanometer scale (atomic, molecular, and macromolecular scale) that produces structures, devices, and systems with at least one novel/ superior characteristic or property.
