Contamination Control Strategy and Implementation
A recent study of environmental monitoring from an ATMP cleanroom facility will be discussed in relation to incubators and pass-thru decontamination. Published data will also be highlighted to convey effective methods in controlling and testing bioburden into the cleanrooms, restricted access barrier systems (RABS), Isolators, and biological safety cabinets (BSCs). Examining and reviewing these data points will provide the information needed to develop a complete holistic approach to controlling bioburden from entering cleanrooms and BSCs.
Cell Processing in Isolators
Isolators are a proven barrier technology for aseptic processing and are the preferred option for many to eliminate direct human interaction with the product. Adapting isolators for cell therapies (CTs) is possible, although CT processes are very manual in nature and often subject to time limits and other constraints. Once process limitations such as this are identified, one is able to model the manufacturing process, identifying natural pause points for use in introducing additional components inside the chamber and removing waste containers or materials. It should be noted that operations utilizing an isolator don’t provide a pass for less stringent aseptic practices. One must find the proper balance between advantages and constraints inherent in the use of the technology. Isolators can provide assurance that a product is safe and sterile and can help teams demonstrate this during inspections. The patient should always be the primary concern, and a barrier system can grant advantages in meeting their needs for high-quality products for the right applications.
Implementing Right First Time
In the rapidly evolving field of ATMPs, ensuring that patients receive timely and effective treatments is paramount. This track will include a presentation that will explore implementing a "right first-time" (RFT) design approach in ATMP manufacturing. By focusing on precision and efficacy from the outset, RFT design minimizes errors and reduces the need for costly and time-consuming reworks. The discussion will cover a recent project where this methodology was successfully applied to streamline production processes and accelerate delivery timelines.
Through a case study, experts will illustrate how integrating RFT principles facilitated a seamless transition from development to manufacturing, ensuring that each step met stringent quality standards. The project harnessed advanced technologies and robust project management strategies to align production capabilities with patient needs swiftly and reliably. Attendees will gain insights into the practical application of RFT design, including its impact on operational efficiency, cost reduction, and patient outcomes. Attendees will learn how adopting a RFT approach in ATMP manufacturing can revolutionize production, meeting the urgent demands of patients while maintaining the highest standards of efficacy and safety.
Bringing Pharma 4.0™ to ATMPs
Industry 4.0 is to the point where there is consideration of what Industry 5.0 will look like. Pharma 4.0™ is in full swing of implementation, but ATMPs have not broadly started adaptation. Bespoke and manual manufacturing processes present challenges to implementation; however, digitization of workflows can support aseptic manufacturing in ATMP applications without changing the process.
Resiliency in Manufacturing
The development of autologous cell therapies presents unique manufacturing challenges, necessitating the implementation of robust resiliency and redundancy strategies to ensure consistent and reliable patient outcomes. As personalized medicine advances, the complexity of these patient-centric therapies underscores the need for uninterrupted production, supply chains, and methodologies for assessing risk.
The track explores the key challenges and solutions in designing resilient and redundant systems within autologous cell therapy facilities and operations. We will discuss strategies for mitigating risks associated with process interruptions, technological failures, supply chain disruptions, and facilities design and maintenance. Through a case study of AstraZeneca’s Rockville Manufacturing Center cell therapy facility, experts will provide an overview of enhancing the reliability and stability of autologous cell therapy manufacturing. The focus will be the design strategy of this facility and improving patient care and treatment availability by leveraging equipment and space redundancy, rolling shutdowns, strategic load shedding, and backup systems ensuring 24/7/365 manufacturing in autologous cell therapy.
Sterility Testing in Cell and Tissue Therapies
Cell and tissue-based products by their nature are not sterile but must be carefully produced and tested to ensure they are aseptic. Not only the product itself but also the matrix (e.g., media, infusion buffer) can have a significant impact on the effectiveness of the sterility testing methods. Microbial enumeration tests (USP <61>) and sterility tests (USP <71>) are compendial methods for meeting regulatory requirements of pharmaceutical product quality manufacturing in US markets. These methods are reliable and consistent; however, results can take approximately five to seven days for bioburden testing and no less than fourteen days for sterility tests.
There is much attention within the pharmaceutical manufacturing industry on the adoption of alternative microbial detection methods that may provide an earlier time to result. Adoption has been limited due to the longer regulatory pathways to approval than compendial methods. This conference will explore special considerations developing sterility test methods and aseptic assurance for Cell and Tissue-based products. Alternative test methods for rapid assessment of aseptic products with short shelf lives will be presented by both Sumitomo Pharma for their commercially approved engineered tissue, Rethymic, and by the US Food and Drug Administration (US FDA).
First-Hand Experience Commercializing ATMPs
Industry professionals today are challenged by many aspects of the advanced therapy lifecycle: scale-up (including batch yield, run rate, and scale), effective collaboration with process development, long-term planning, and network strategy. This conference presents an opportunity to talk with those who have gone through the launch of commercial ATMPs via Q&A at technical presentations, panel discussions with audience input, or conversations between presentations.
Resiliency is key in turning scientific advancements into products that change the disease outcomes. This track is for any pharmaceutical professionals looking to explore recent innovations, address ongoing challenges, and collectively advance the field of ATMPs. All are invited to join ISPE for the 2025 ISPE Aseptic Conference, taking place 17-18 March in Washington DC, USA, where these crucial discussions will unfold. Participation is vital in collectively advancing the field of ATMPs.
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