Good manufacturing practice requirements for the production of tissue vitrification and warming and recovery kits for clinical research

Monica M. Laronda, Kelly E. McKinnon, Alison Ting, Ann V. Le Fever, Mary Zelinski, Teresa K. Woodruff

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Products that are manufactured for use in a clinical trial, with the intent of gaining US Food and Drug Administration (FDA) approval for clinical use, must be produced under an FDA approved investigational new drug (IND) application. We describe work done toward generating reliable methodology and materials for preserving ovarian cortical tissue through a vitrification kit and reviving this tissue through a warming and recovery kit. We have described the critical steps, procedures, and environments for manufacturing products with the intent of submitting an IND. The main objective was to establish an easy-to-use kit that would ensure standardized procedures for quality tissue preservation and recovery across the 117 Oncofertility Consortium sites around the globe. These kits were developed by breaking down the components and steps of a research protocol and recombining them in a way that considers component stability and use in a clinical setting. The kits were manufactured utilizing current good manufacturing practice (cGMP) requirements and environment, along with current good laboratory practices (cGLP) techniques. Components of the kit were tested for sterility and endotoxicity, and morphological endpoint release criteria were established. We worked with the intended down-stream users of these kits for development of the kit instructions. Our intention is to test these initial kits, developed and manufactured here, for submission of an IND and to begin clinical testing for preserving the ovarian tissue that may be used for future restoration of fertility and/or hormone function in women who have gonadal dysgenesis from gonadotoxic treatment regimens or disease.

Original languageEnglish (US)
Pages (from-to)1-10
Number of pages10
JournalJournal of Assisted Reproduction and Genetics
DOIs
StateAccepted/In press - Nov 30 2016

Fingerprint

Vitrification
Investigational Drugs
Investigational New Drug Application
Research
Tissue Preservation
Gonadal Dysgenesis
Drug Approval
United States Food and Drug Administration
Infertility
Fertility
Clinical Trials
Hormones
Food
Therapeutics

Keywords

  • Good manufacturing practice
  • Oncofertility
  • Ovary
  • Vitrification

ASJC Scopus subject areas

  • Reproductive Medicine
  • Genetics
  • Obstetrics and Gynecology
  • Developmental Biology
  • Genetics(clinical)

Cite this

Good manufacturing practice requirements for the production of tissue vitrification and warming and recovery kits for clinical research. / Laronda, Monica M.; McKinnon, Kelly E.; Ting, Alison; Le Fever, Ann V.; Zelinski, Mary; Woodruff, Teresa K.

In: Journal of Assisted Reproduction and Genetics, 30.11.2016, p. 1-10.

Research output: Contribution to journalArticle

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