Page 15 - Assurance of Sterility for Sensitive Combination Products and Materials

CHAPTER 2

Sensitive combination products:

Devices, pharmaceuticals, and

biologics

Andrew L. Lewis
Biocompatibles UK Ltd, a BTG International Group Company, Camberley, United Kingdom

Contents
2.1 Introduction to combination products 5
2.2 Considerations for sterilization of combination products 8
2.2.1 Drug-enhanced devices 10
2.2.2 Drug delivery systems: Traditional and novel 13
2.2.3 Regenerative medical devices with biologics 16
2.2.4 Electronics, bioabsorbables, and other novel materials and the
future of combination product development 19
References 21

2.1 Introduction to combination products
Combination products have been in existence for many decades now but
since the turn of the millennia, there has been a more rapid evolution of
complex therapeutic products that fall between the lines of the classic defini-
tions of a drug, device, or biological product. This prompted the FDA (Food
and Drug Administration) to form the Office of Combination Products in
2002 in an effort to act as a resource and provide guidance to industry, to
classify, assign, and oversee the regulation of products that fall within their
definition of a combination product (see Fig. 2.1).
Manufacturers can formally request designation for their products based
on arguments that define its principal function within the body, which
determines which branch within FDA will take lead on regulation of the
product. The FDA follows a clear algorithm that first considers the greatest
contribution to the overall intended therapeutic effect of the combination
products—the so-called primary mode of action (PMOA). Sometimes this
in itself can be unclear, in which case they turn to the agency that either

Assurance of Sterility for Sensitive Combination Products and Materials © 2020 Elsevier Inc.
https://doi.org/10.1016/B978-0-12-805082-8.00002-5 All rights reserved. 5