ISPE Briefs: New ISPE Guides Explore ATMPs and Update Guidance on CTCs
Marcy Sanford
Released in November 2021, the ISPE Guide: Advanced Therapy Medicinal Products (ATMPs)–Autologous Cell Therapy focuses on manufacturing facility development and design for autologous cell therapies for parenteral use. This guide provides an overview of the critical aspects of ATMP facility design as well as the key relationship between current process/facility attribute alignment and how that changes in the ATMP space.
The growing number of autologous products that are entering the pipeline is evidence of the growth potential of this therapeutic approach. The science has promised this for years; it is now delivering on the promise, and it gives new promise and hope to patients that have rare conditions or diseases. It is a game changer. The product-process relationship for ATMPs is very different from the traditional cell culture-based approach that most people are familiar with. And because the ATMP space has its roots in the academic/hospital environment in a much smaller scale, the application of GMPs to the overall manufacturing operations is a different challenge.
While the guide focuses on autologous cell therapies, it provides content that may be applicable to other types of ATMPs. Written by a team of experts in the ATMP field, this is the only guide of its kind in the industry about the development and design of ATMP manufacturing facilities.
Published in December 2021, the Second Edition of the ISPE Good Practice Guide: Controlled Temperature Chamber–Commissioning and Qualification, Mapping and Monitoring provides guidance on the life cycle management of GMP-controlled temperature chambers from creating a user requirements document to decommissioning a unit. Originally published in 2016, the guide has been revised to align with current industry practice, particularly with respect to the ISPE Baseline® Guide: Commissioning and Qualification (Second Edition), and presents a cost-effective way of demonstrating and maintaining compliance.
Whether you are new to the business of storing samples, a university looking for answers for small scale storage, or have been doing this for years and are going through the process of benchmarking to assure alignment with the industry, this guide provides the information and ‘real world’ examples of successful practices being used today, right now, to safely store samples and to meet compliance objectives with many regulatory agencies. This guide will help you save time and money by not having to reinvent the wheel and provides you with a strong starting point to building most any sample storage operation.
The controlled temperature chambers discussed in this guide range from purchased commercial off-the-shelf items, such as freezers and refrigerated delivery vehicles, to walk-in cold rooms and walk-in freezers, to custom-built units such as warehouses. The risk-based approaches covered include com-missioning, temperature mapping, and periodic review, along with examples and sample templates.
Meet the ISPE Staff: BILL MOJICA
In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Bill Mojica, Director of Development & Foundation Operations, ISPE Foundation.
Tell us about your role at ISPE: what do you do each day?
Identify, cultivate, and steward individual donors and corporations to support the ISPE Foundation. Build awareness of our mission and initiatives. Being new to the industry, I am challenged to increase my knowledge base on all things pharma.
What do you love about your job?
I love meeting new people. Fundraising is based on relationship building. Therefore, I have the unique opportunity to meet folks from around the world who are dedicated to saving lives. I am blessed to work with an incredibly talented and passionate team at ISPE.
What do you like to do when you are not at work?
I’ve been a high school football coach for over 30 years. It is an honor to mentor young men and teach the game I’ve loved my entire life. I also play drums in various bands around Baltimore, Maryland, and my wife and I love to travel!
Catherine Hall is Chair of the Investigational Products, North America (IPNA) Community of Practice (CoP) Steering Committee and is one of the authors of the ISPE Good Practice Guide: Investigational Medicinal Product Reverse Logistics – Good Returns and Reconciliation Practices. She has been a member of ISPE for 18 years.
Hubertus Rehbaum, PhD, is Chair of the Process Analytical Technology & Lifecycle Control Strategy (PAT-LCS) Community of Practice (CoP) Steering Committee. He’s been a member of ISPE for eight years. He first became involved through the Germany/Austria/Switzerland (D/A/CH) Affiliate when he joined as an Emerging Leader and helped co-host events for the group, which he said helped him...
