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Human Blood Origin Materials for Cell & Gene Therapy Manufacturing Supplier Questionnaire
Materials derived from human blood such as human serum albumin and transferrin are frequently used either as components of cell culture medium or in other processes. Suppliers of such reagents have incorporated multiple mitigation steps such as sourcing pharmaceutical grade or licensed drug product, sourcing from safe geographical regions, testing for contaminants and inactivation. In addition, this information needs to be available for review during inspections and in regulatory filings. This questionnaire is a comprehensive list of those requirements and will be a useful document for reference.
Human Blood Origin Materials for Cell & Gene Therapy Manufacturing Supplier Questionnaire
Materials derived from human blood such as human serum albumin and transferrin are frequently used either as components of cell culture medium or in other processes. Suppliers of such reagents have incorporated multiple mitigation steps such as sourcing pharmaceutical grade or licensed drug product, sourcing from safe geographical regions, testing for contaminants and inactivation. In addition, this information needs to be available for review during inspections and in regulatory filings. This questionnaire is a comprehensive list of those requirements and will be a useful document for reference.
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Rx-360 Continues Growth with Key Leadership Appointments
Philadelphia, December 1, 2022 — Rx-360, an international pharmaceutical supply chain consortium, is proud to announce that it has hired Ben Mills as Senior Director of Operations, Joint Audit Program/Quality, and Kristen Farr as Senior […]
Rx-360 Best Practices Quality Agreement Guide
This Best Practices Quality Agreement Guide is intended to assist both Customers and Suppliers in efficiently managing the initiation, negotiation, implementation, and ongoing maintenance of quality agreements. “Supplier” is used broadly in this document to […]
10+ Year Rx-360 Member Reaches Audit Milestone
The Rx-360 Credit Program is a members-only benefit that GSK has found to be tremendously valuable, as it has generated nearly $100,000 in credits for the science-led global healthcare company. “Not only does Rx-360 […]
Episode 5: Interview with Best-Selling Author Katherine Eban
Host Jim Fries speaks to Katherine Eban, contributing editor for Vanity Fair and a New York Times best-selling author, in the fifth episode of The Patient Safety Podcast. Eban walks Fries through her investigation into […]
Meet The Board: Kate Silva, MilliporeSigma
Kate Silva is the Head of Quality Management Systems and Audits for MilliporeSigma. In this role, she is responsible for overseeing the global life science framework for compliance with quality, regulatory, and industry standards. Kate […]
Episode 4: Interview with Leigh Verbois, Director of the Office of Drug Security, Integrity and Response for the FDA
Host Jim Fries speaks to Leigh Verbois, the Director of the Office of Drug Security, Integrity, and Response for the FDA, in the fourth episode of The Patient Safety Podcast. The episode covers Verbois’ time […]
Human Blood Origin Materials for Cell & Gene Therapy Manufacturing Supplier Questionnaire
Materials derived from human blood such as human serum albumin and transferrin are frequently used either as components of cell culture medium or in other processes. Suppliers of such reagents have incorporated multiple mitigation steps such as sourcing pharmaceutical grade or licensed drug product, sourcing from safe geographical regions, testing for contaminants and inactivation. In addition, this information needs to be available for review during inspections and in regulatory filings. This questionnaire is a comprehensive list of those requirements and will be a useful document for reference.
Meet The Board: Bill Campagna, Eli Lilly and Company
Bill Campagna is the Senior Director of Quality for Procurement and Operations for Eli Lilly and Company; and he’s passionate about serving on Rx-360’s Board of Directors. “I’m proud to be part of Rx-360’s Board […]
Rx-360 Patient Safety Podcast: Interview with USP CEO Ron Piervincenzi, Ph.D.
Rx-360 released the third episode of The Patient Safety Podcast, featuring Ron Piervincenzi, Ph.D., CEO of the United States Pharmacopeia (USP).
Episode 3: Interview with Ron Piervincenzi, CEO of The United States Pharmacopeia
Host Jim Fries speaks to Ron Piervincenzi, Ph.D., CEO of the United States Pharmacopeia (USP), in the third episode of The Patient Safety Podcast. The episode covers topics such as Piervincenzi’s time at USP, the […]