Page 261 - Assurance of Sterility for Sensitive Combination Products and Materials

CHAPTER 10

Path forward

a
Byron J. Lambert , Joyce M. Hansen b
a Assurance of Sterility Task Force, ASTF, Abbott, Temecula, CA, United States
b J&J Sterility Assurance, Johnson & Johnson, Raritan, NJ, United States
Contents

10.1 What is next with combination products? 239
10.2 Sterility assurance landscape in the 2020s 240
10.3 Pan-industry sterility assurance risk framework 240
10.3.1 Sterility assurance risks in health-care facilities 241
10.3.2 Sterility assurance risks related to single-use products 241
10.4 What is next for sterility assurance professionals? 242
10.4.1 End-to-end sterility assurance 242
10.4.2 Bringing it all together in a risk management framework 243
10.5 What is next for the patient? 243
References 244

10.1 What is next with combination products?
Chapter 2 highlighted that combination products and biologics for regen-
erative medicine are bringing increased value to patients and increased need
for creative sterility assurance solutions. In broader context, combination
products, pharmaceuticals, and biologics are key for finding innovative solu-
tions to the most challenging and pervasive unmet clinical patient needs in
neuroscience, oncology, cardiology, and pulmonary disease. These four areas
alone represent untold human suffering and a &45T economic burden to
society [1].
Combination product opportunities for meeting patient needs and
related challenges for assuring sterility are further elevated with bioab-
sorbables, microelectronics, and multiple active agents. Sterility assurance
professionals need to facilitate these innovative products with timely solu-
tions for sterility assurance challenges so that the pipeline of new products
for needy patients is not unnecessarily restricted.

Assurance of Sterility for Sensitive Combination Products and Materials © 2020 Elsevier Inc.
https://doi.org/10.1016/B978-0-12-805082-8.00010-4 All rights reserved. 239