Standard Guide for Evaluation of in vitro Release of Biomolecules from Biomaterials Scaffolds for TEMPs

Importancia y uso:

4.1 European and U.S. Pharmacopeia provide test methods for measuring release of a drug analyte, and USP <1001> provides a method that is intended to be applicable to implanted products. However, the characterization of biomaterial scaffolds that release biomolecules presents unique challenges not present in other drug or drug-releasing products.

4.2 An appropriately designed in vitro release test would be favorable in the early stage of development of biomolecule-releasing scaffolds for TEMPs, as well as in quality control, and may help to reduce the number of animal experiments.

4.3 Appendix X1 provides a tabulated overview of published in vitro release studies performed with biomaterial scaffolds loaded with biomolecules.

4.4 One goal of in vitro release studies is to simulate the in vivo conditions as closely as possible, but with sufficiently simplifying abstraction. The simplification comprises two general aspects: the amount of fluid or release medium in contact with the implant to simulate the physiological environment, and the composition of that release medium.

Subcomité:

F04.42

Referida por:

F3510-21, F3354-19

Volúmen:

13.02

Número ICS:

11.100.10 (In vitro diagnostic test systems)