iSpeak Blog

What Is Next in Manufacturing Injectable Sterile Products?

Keith W. Weseli, CPIP
What Is Next in Manufacturing Injectable Sterile Products?

As we enter the new year, this is the perfect time to make the 2021 ISPE Aseptic Conference part of your personal professional development plans. The virtual conference will allow participation from across the globe with no risk to pandemic exposure. The three-day format with shorter sessions will minimize impact to workdays and will allow attendees to participate in the sessions that will be most impactful to their personal interests.

The experience of the past year has been surreal for many of us. It amazes me to hear public discussions of pharmaceutical manufacturing and supply chain challenges as society wrestles with overcoming COVID-19. There has never been more focus on the manufacturing of injectable sterile products. Society is counting on us to learn, collaborate, and share best practices to deliver lifesaving solutions that are needed now more than ever!

This will be my second year serving on the planning committee for this conference. I am honored to serve as moderator for two specific sessions. The first session’s speakers will address the facility considerations for manufacturing next generation sterile products, which definitely piques my interest as someone who works on facility deliver projects.

  • What facility attributes, people, and equipment flows will best facilitate the product needs of Advanced Therapy Medicinal Products (ATMPs)?
  • How can small, personalized batches be produced effectively and efficiently and at the scales necessary to deliver these potentially life-saving products?

The baseline batch-driven biomanufacturing process paradigm has been broken by the ATMPs, with their targeted approach to a specific patient rather than the “one size fits all” traditional biomanufacturing approach. With a personalized delivery, there can be no mistakes when manufacturing treatments for multiple patients concurrently. Transportation times and controlled storage conditions are critical to the therapy’s efficacy. ATMPs do not have the decades of manufacturing and regulatory guidance behind them. Similar manufacturing unit operations are present, but the volumes are smaller with a limited number of batches. ATMPs also generally prevent the use of sterile filtration or terminal sterilization, thus requiring aseptic processing steps throughout. Regulators may challenge the potential large number of manual single-use sterile connections demanded by the manufacturing process. This is suitable for clinical scale operations but what changes are needed when the facility needs to produce at commercial scale? Contamination risk becomes unacceptably high with repeated manual operations, thus demanding the introduction of automated solutions. Many gene/cell therapy facilities will utilize live virus during production which introduces additional design and operational considerations to ensure aseptic handling throughout and appropriate operator safety protections. These challenges and more will be discussed by Tyler Kaleta of DPS Group during his presentation titled Challenges Associated with Gene/Cell Therapy Facilities.

2021 ISPE Aseptic Conference

Peter Walters, CRB, will present with Matthew Hewitt, Lonza, on the potential “magic bullet” for ATMPs—multimodal manufacturing during their presentation titled ATMP Facilities: Multimodal Manufacturing for a Magic Bullet. The need for multi-modal facilities is timely given the prevalence of mergers and acquisitions of start-up companies by the larger biotech and pharmaceutical companies. Start-ups may only have one modality of treatment, but larger companies may have a plethora of ATMP product lines that need to be manufactured in their facilities. Given that the treatments are novel, there is uncertainty over which modality will be commercially successful. Manufacturing flexibility will counter this uncertainty through optimizing product combinations based on manufacturing and regulatory similarity and compatibility. This session will explore how this multi-modal ATMP facility can be achieved.

The second session I will facilitate on St. Patrick’s Day will address Devices and Decontamination. The two sessions will provide technological solutions for potential aseptic manufacturing challenges. There is always a need to maximize the lifetime of equipment.

Ken Nagai works as a Global Business Development Director for Airex, an isolator/decontamination equipment company for the pharma and ATMP industry, will present an innovative approach to decontaminating aging isolators or isolators used for ATMP production. He will present the technical details on the UltaDecon decontamination system, which can provide significant operational flexibility by achieving a 6-log reduction in a little as 5 minutes time.

Massimiliano Cesarini will present on a new combination product technology to be released to the market—a freeze dried vial paired with an aseptically filled bag. Putting these pieces together will constitute a ready-to-mix device. This technology presents process challenges that must be overcome, which in turn will open up regulatory concerns and verification methodology that must be addressed. In looking at the video of the process, one thought comes to mind—“cool!”

This is just a snapshot of two sessions of the many rich offerings that will constitute the 2021 ISPE Aseptic Conference. I hope to “see” you there!

Learn More & Register