
The need to take advantage of new technologies and explore new ways for process control and efficiency permeates all areas of pharmaceutical manufacturing. Recent emerging technologies in aseptic processing such as advanced isolators, robotics, and increased automation have changed the industry and reduced contamination risks for sterile products. Simultaneously, modern therapies - new, targeted approaches to treatment resulting in small-batch aseptic products - are proving more difficult to sterilize and handle and requiring faster speeds to market. Furthermore, the updated Annex 1 will impact the manufacture of sterile products, setting new requirements for Quality Risk Management, Contamination Control Strategy, and Data Management and Compliance for Computerized Systems. The requirement to re-think the existing standards is becoming more urgent.
Thus, as we slowly navigate to the post-COVID world and return to normal, ISPE’s Aseptic Conference wants to realign our focus. We welcome you to participate at the 2023 ISPE Aseptic Conference to learn and share progress, success stories, best practices and lessons learned. See you in North Bethesda, Maryland!
Given the impact of the evolving pandemic, an aging population, the increase in diseases with unmet needs, and an unprecedented rise in chronic diseases, the need for a constant focus on collaborative innovation and agility will shape Pharma’s priorities in the foreseeable future. ISPE will be the leader to set the pace for knowledge sharing that speaks to the current and future needs of the industry.
The 2023 ISPE Aseptic Conference reviewers are requesting proposals aligning with the following content areas:
Applying harmonized approaches to innovative design solutions and project delivery strategies to ensure that quality therapeutic products are brought to market in an efficient manner to improve patient health. This includes manufacturing process improvement, the business strategies, and technology associated with the future state of manufacturing.
Regulatory and quality challenges, learnings, and opportunities which might include the current speed to market expectations, pandemic management, drug shortages, and the regulatory focus on data integrity and sterile manufacturing.
The impact and potential utilization of new technologies, processes, and disruptions on operations and logistics of the production of all types of therapies.
Emerging and evolving technologies and practices that are helping drive a revolution in medicinal therapies, analytical techniques, manufacturing paradigms, medical devices including novel methods to deliver the next generation of drugs to patients.
Examples of possible submissions/case studies/use cases could be any of the following:
These presentations are to be made part of a larger session by the Program Committee. Presentation should focus on new and innovative trends, a specific real-world strategy or campaign, a “how-to" presentation intended to help attendees gain a better understanding of the initiative and best practices that they can apply to their day-to-day objectives or overall missions.