The topic of aseptic manufacturing remains as relevant to the pharmaceutical industry as it is to patients: new drugs in development are predominantly injection drugs and need to be sterile. In fact, sterile dosage forms will surpass all other dosage forms in value within the next years.
While the development of RABS and Isolators has kept us busy and still does, new modalities are emerging. We are dealing with high potent compounds that also require strict operator protection. ATMPs, “advanced therapeutic medicinal products” challenge us to re-think processes and develop new ones. Autologous and allogenic cell therapy bring drug substance and drug product manufacturing closer together and ultimately lead to the batch size of one filled unit. Robotic solutions in fill-finish have become more and more common, with robots performing tasks unheard of a few years ago.
Regulations are also evolving: 2020 saw the second commenting period on the EU Annex 1, with thought-provoking debates within the industry and with regulators around the globe: after all, PIC/S and WHO were heavily involved in this process.
And let’s not forget the thrills of developing, testing and producing the first SARS-Cov2 vaccines and therapeutics, all within 10 months. All of a sudden, we see our processes discussed in the media!
We will kick off the conference with a key note address from FDA’s Office of Vaccines Research and Review (invited). In combination with the industry key note talk by Jean Hu Primmer, Global Regulatory Lead, GSK Vaccines (Former Sr. Advisor, FDA for CBRN & Pandemic Influenza and BARDA Influenza division) we will get insights into the latest development around vaccines.
The conference will then break out into concurrent sessions on the different topics, always with plenty of time for questions and answers from the audience.
The topics in the break out sessions cover a broad range of aspects of aseptic processing, with real-life case-studies and lessons learned:
- ATMPs and New Technologies
- Contamination and Cross Contamination Control
- Facility Considerations for Next-Generation Sterile Product Manufacturing
- Containment: Understanding Why, When, and What Regulatory Agencies Expect
- H2O2: Not the Same old Topic
- Modular Robotic Fill/Finish Lines
- Single Use Technologies – Why all the hype? Is it really worth it?
- Process Safety
- Devices and Decontamination—Overcoming Challenges
- Regulatory View on ATMPs and Make vs. Buy
After commenting from ISPE and other organizations on the draft Annex 1 in July, numerous discussions have been held in industry and together with regulators, including a session at ISPE Annual Meeting with the rapporteur to EMA, Ali Sarakha from ANSM, Paul Gustafson from Health Canada, also representing PIC/S and others. We will report on the key learnings of these discussions in a plenary session.
The highlight of the conference will be the panel session with regulators again, all from different departments of the FDA, including Bob Sausville, an Aseptic Conference veteran. They will talk about the current challenges the industry is facing in this pandemic situation, both from a regulatory perspective as well as from development, testing, manufacturing and distribution of the new drugs and vaccines. The panelists will also take questions from the audience, so come prepared!
The 2021 ISPE Aseptic Conference will be address a multitude of aspects in a virtual setting, while keeping it as interactive as possible. Timing of the conference is ideal in that it covers working-hours both in the USA and in Europe, leaving ample time for participants to be there and still get their day jobs done.
To round it off, there will be a virtual exhibition with relevant suppliers of equipment and services, from lyophilizers and filling equipment to services like commissioning, calibration and consulting. The demo stage in the Partner Showcase will feature additional topics like serialization and block chain.
In the breaks from the education sessions, there is also a virtual ISPE Networking Lounge as featured in other recent ISPE events. Here, you can meet old friends and get acquainted with new people. (I had such a good time there during 2020 ISPE Annual Meeting & Expo with a group of students from the Philippines.)
This is the one event in 2021 that you cannot afford to miss if you are in the field of aseptic processing. Be there or be square!
Learn More
