ISPE blog explores ATMP production challenges and opportunities

Blog by CRB SMEs examines new ways to speed the path from lab to production.

Across the world, the rise in clinical ATMP trials is creating new urgency around commercialization processes and how companies can hasten the move from “trial to vial.” In a new blog post published by ISPE’s Pharmaceutical Engineering magazine, CRB process engineer Christopher Slevin and CRB architect Marie Boatright explore the challenges of ATMP commercial production – from simulations and supply chain to equipment and space allocation.

Pharmaceutical Engineering is ISPE’s technical magazine devoted to covering the research, development, and manufacture of medicines and medical devices. In the post, Boatright and Slevin write that “the sharing of Advanced Therapy Medicinal Product design ‘lessons-learned’ is imperative. We were recently involved in an ATMP project where we felt the learning curve first-hand. We have boiled down our experience here to highlight a few eye-opening challenges specific to Advanced Therapy Medicinal Product manufacturers and how these challenges can affect commercial facility design.”

The blog goes in depth in these key areas:

• meeting targeted facility throughput via process modeling and simulation
• transitioning from lab to commercial
• equipment and space allocation
• designing for personnel
• warehousing and supply chain
• future facility considerations, including flexibility, redundancy, and evolving technology

“It can be a rigorous and confusing process to design an Advanced Therapy Medicinal Product facility for those with limited experience in doing so,” Slevin and Boatright note. “By employing process simulation and taking into account the various factors presented here, one can have confidence in beginning to create a facility that will allow for the safe production of high-quality ATMP materials while also providing a path for scalability as business develops.”

For instance, the authors suggest that because ATMP production, specifically cell therapy, is primarily manually operated, it can be difficult to understand the breadth of facility requirements in the absence of thorough simulations or modeling.

“Manual processes naturally include more variables and conjecture than automated processes,” Boatright and Slevin write. “Imagine a well-defined bioreactor campaign with set durations, additions, automated transfers and validated cleaning/steaming cycles. Along with historical benchmarking, a quality process schedule also can be assembled. Throughput can be estimated with relative ease and accuracy early in the design, based upon known and proven automatic processes.”