Join ISPE to celebrate the 2022 Facility of the Year Awards Celebratory Reception and Banquet where we will formally recognize and celebrate the 2022 Category winners' achievements at ISPE’s premier award presentation ceremony and dinner.

Digitalization opens new horizons to achieve new levels of connectivity, transparency, agility and productivity through the application of faster and more accurate information to enable (automated) decision-making. The fundamentals of the digitalization process lies in in the structure underneath the data being created, used, reported, stored, and destroyed. 

Currently, in the Pharma 3.0 environment the approach for automation is in a process-centric environment. However, moving to Pharma 4.0™, a different approach in which the data life cycle is centralized, will lead to a data-centric approach. Each data life cycle needs to be completed and aligned to be considered a data set. In current production processes different data sets are created for each process. Visualizing the data sets amongst different process steps will automatically trigger missing data, misaligned data or duplicate data. Moving to Pharma 4.0™, each data set will need to be assessable at any time in any business layer. 

Therefore, a system needs to be in place to show the data architecture and how it interacts with various processes. This session will discuss the status and examples of practical transformational methodologies to a digitalized Pharma 4.0™ Operating Model-based organization.

Today’s manufacturing platforms and associated analytics are smaller, lighter, and significantly more modular versus their predecessors. These technological advances are enabling much smaller factory footprints, allowing a transportable manufacturing platform and facilities paradigm to gain considerable traction as a viable alternative to more traditional equipment train and facilities constructs. Flexible, transportable units have the potential to address variable demand through scale-out, take advantage of off-site fabrication principles, and may be installed more quickly than for traditional construction practices. 

Consequently, when business needs change, as they so often do, manufacturing units can be relocated. The potential financial, technical, quality, and regulatory challenges vs. opportunities associated with the movability of the manufacturing environment will be addressed and case studies will be presented to illustrate the challenges vs. benefits of mobility and operating a mobile facility. 

Presentations will provide perspectives on advanced biopharmaceutical manufacturing trends drawn from the work of ISPE's Product Quality Lifecycle Implementation (PQLI)® team and subteam, ISPE PQLI Transportable/Point of Care Manufacturing Technology team.

While pharmaceutical GMPs and their associated guidelines recommend a quality unit that is independent of the manufacturing unit, they give little or no information on its organizational construct. This session will explore how to build a pharmaceutical quality system to meet ICH Q10 expectations to “assure the desired product quality is routinely met, suitable process performance is achieved, the set of controls are appropriate, improvement opportunities are identified and evaluated, and the body of knowledge is continually expanded.”

Additionally, the speakers will address how to build an organization with a sustainable quality culture and meet all necessary compliance requirements internationally. Senior leaders from a start-up company (Phlow), a spin-off company (Organon), and a rapidly growing company (Moderna) will discuss how to balance addressing compliance needs and planning for expanding roles, commensurate with evolving company capabilities and capacity.

The COVID pandemic, and more specifically, Operation Warp Speed driven projects, rocked the global supply chain and taught the industry that the paradigm of typical project durations could be shattered. The success of a number of these projects has driven the industry to expect an unprecedented level of speed on future projects. Good Engineering Practices are critical to the delivery of compliant biopharmaceutical projects; however, their application is absolutely crucial as design, procurement and verification activities are conducted throughout fast-tracked projects. 

This session will describe the concepts of the guide, the principles and drivers behind its revision, and the practical application of the guide for customers’ use. In addition, speakers will provide a case study of a BARDA funded Operation Warp Speed BSL-2 Aseptic / Isolated Formulation and Filling Facility with a project duration of 11 months from concept to aseptic process simulation readiness, which completely challenged the paradigm and basic understanding of how fast a project would be delivered from concept through CQV.

In this session, experts will discuss patient centric approaches to drug development, focusing in on applications to product quality. The session will start with a broad discussion of patient centric development strategies and subsequently narrow in on how these ideas can be applied to ensure drug quality. The development of patient centric or clinically relevant specifications builds on existing industry guidance and utilizes the science and knowledge generated through the development and the lifecycle of a pharmaceutical product. By taking this understanding and applying it to establish specifications that focus on the patient, rather than simply the batch data available at time of clinical/marketing application, significant benefits can be gained for both regulatory agencies and industry.

The session will cover the application of patient centric specifications and discuss how revisions to ICH Q6A/B could embrace these ideas. Wider adoption of these principles could form the cornerstone to achieving global regulatory harmonization, reducing the complexity of managing a product through its lifecycle, reducing environmental impact from our pharmaceutical processes, improving supply chain robustness, and potentially minimizing drug shortage and disruption of supply of medicines to patients.

Maintaining the principles and framework of the first edition, ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) updates their application in the modern world including the increased importance of service providers, evolving approaches to software development, expanded use of software tools and automation, and modern approaches to managing infrastructure.

The session highlights the use of critical thinking by knowledgeable and experienced SMEs to define appropriate approaches.

Presentations delivered in this session will provide a foundation for the "**New GAMP 5** 2nd Edition roundtable" session which follows on after this session and will allow for a deeper dive into the detail of the Second Edition.

The use of Hydrogen Peroxide (H2O2) for decontamination of equipment and/or medical devices has traditionally relied on initial validation and periodic revalidation to check the efficacy of the process with biological indicators (BIs). Enzyme Indicators (EIs) are an innovative rapid tool for providing instant and quantitative feedback, of H2O2 efficacy by providing real time quantifiable data when applied to cycle optimization, qualification, continuous process monitoring and trouble-shooting.

This session will provide an overview of the technology and how it can be used throughout the validation phases whilst showcasing data from various pharmaceutical companies and their collective suggestions on applications and future usage of EIs. Presentations will demonstrate the EIs ability to aid, clarify and provide additional confidence of H2O2 cycles and also share details of how a working group has been established to provide a consistent approach to industry application of H2O2 decontamination including the use of EIs.

This session aims to provide a diverse set of perspectives on quality/regulatory topics as it pertains to late stage/commercial ATMPs (primarily autologous cell therapy). The goal is to bring industry and regulators together to discuss shared challenges and highlight learning opportunities for both as this field evolves. In particular, the presenters will provide a good view of what areas of opportunity exist - focus areas on capacity expansions/needs, aseptic processing challenges, raw material challenges, and inspection aspects are examples of the topics that would be mutually beneficial as well as of great interest to attendees. While technical challenges are at the forefront of this complex manufacturing environment, the regulatory and quality considerations associated with these need to be factored in so that health authority expectations can continue to be met. Further industry-regulator collaboration will aid in this effort.