2023 ISPE Aseptic Conference
Conference Overview
Please Note:
- All full-access registration (virtual & in-person) includes access to speaker presentations, on-demand content, and other conference material.
- NOTE: Material is only available from those speakers/companies that permitted distribution.
- Registrants will receive email notification when the on-demand content is available.
- On-demand content is accessible for 90 days.
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 the new 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!
Featured Speakers
Attendee Prospectives
Featured Topics
- Annex 1 Solutions and Implementation
- Robotics and Digitalization
- Manufacturing Case Studies
- Process Control and Quality Risk Management
- ATMPs/Cell & Gene Therapies
- Contamination Control in Aseptic Processing
- Decontamination and Single-use Systems
- Improvements and New Technologies in Aseptic Manufacturing
- Microbiology, Cleaning, and Training
- 3 Discussion Groups: Aseptic Processing, Contamination Control, and Barrier Technologies
What to Expect
The #1 event for aseptic and sterile manufacturing professionals that has been setting the pace for over 30 years.
- Gain first-hand insights on the newly revised Annex 1, including discussions with ISPE members and stakeholders who provided comments on the draft
- Identify the impact and potential utilization of new technologies, including robotics and digitalization trends
- Examine harmonized approaches to innovative design solutions and project delivery strategies
- Engage directly with regulators about regulatory and quality challenges, learnings, and opportunities
- Explore emerging technologies and practices that are helping drive a revolution in aseptic manufacturing
Overview:
- 7.5+ hours of dedicated networking time.
- 11.5+ hours of dedicated education sessions & learning opportunities.
- 5+ hours of additional sessions available on-demand after the conference. 16.5+ hours total of education from all conference sessions.
- Expansive Expo Hall.
- Expo Hall giveaways & engagements.
- Growth opportunities for Students, Women in Pharma and Emerging leaders.
- 90-minute concurrent sessions with audience interaction.
- Conveniently located in North Bethesda, Maryland.
- Unique perspectives from both industry and regulatory speakers to obtain a wholistic understanding of the trends and issues impacting the Sterile Manufacturing practices.
Conference Highlights
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iSpeak BlogATMPs, Cell and Genetic therapies - or whatever other jurisdictions use – have come a long way. I am unsure how many of us have forgotten the early failures and setbacks. There was a time, in the early years, when serious side effects, such as deaths, endangered the field. It prompted the regulators to halt research, introducing various constraints and safeguards. In Europe, it felt like every...
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iSpeak BlogIt’s hard to imagine life without instantaneous weather and time; however, some readers of this blog may know when weather, some years ago, was a mystery, and accurate time required a call from a pay phone to verify the correctness of your new Timex© watch!
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iSpeak BlogIt has been a long journey from the development of primarily manual aseptic processes to fully automated systems that do not require manual intervention. Looking back in history, it was a step-by-step development forward to the current contamination control strategy (CCS) many decades ago. The risk of contamination of a sterile product from the environment (room) and the people who do work in...
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iSpeak BlogBuilding off of the success of the 2022 ISPE Aseptic Conference, the program committee has developed a robust program covering key areas in aseptic manufacturing, processing, and filling for students, emerging...
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iSpeak BlogMulti-Use Filling Line for RTU Syringes, Vials, Cartridges and Bulk Vials - Photo courtesy of INCOG BioPharma Services
The definition of technology is “the set of knowledge, skills, experience, and techniques through which humans change, transform and use our environment in order to create tools, machines, products and services that meet our needs and desires.” A...
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iSpeak BlogISPE Aseptic is one of those conferences where the depth of knowledge astounds me. When I started attending and speaking at the ISPE Aseptic Conference in the 2000s, I came to grow and learn. -
iSpeak BlogIt is a great honour and pleasure for me as the 2022-2023 ISPE Board Past Chair and Chair of the 2023 ISPE Aseptic Conference Program Committee to give you a first glimpse at the program and of the information and...
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iSpeak BlogThe 2023 ISPE Aseptic Conference will devote one entire day to case studies related to aseptic manufacturing projects. For us, seeing the real-life challenges that the industry is facing and how project teams...
