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Aseptic Process Science & Technologies & New High Potent/Hazardous Aseptic Pharmaceutical Products

Richard Denk
Aseptic Process Science & Technologies & new high potent/hazardous aseptic pharmaceutical Products

The Aseptic Processing is facing the next generation of pharmaceutical products and GMP requirements. The Annex 1 draft is in the final stage and we expect the publication before the next ISPE Aseptic Conference in North Bethesda, MD. The Annex2/PICs updated version with the Questions to the Industry was sent out in September. Many of the questions are related to ATMPs. These are exciting times for all working in the Aseptic Processing sector. Barrier Technologies as RABS or Isolators are the most preferred solutions to keep the pharmaceutical product safe. New, promising oncology products require a high demand for cleaning in shared facilities as well as operator protection during manufacturing. Right now, around 1000 different products are in pre-clinical and clinical studies. Many of those will come to market in the next few years and the fabrication needs to be ready for it.

The 2020 ISPE Aseptic Conference March 2-3 at North Bethesda, MD will offer attendees several unique perspectives and case studies across three separate tracks. In the Aseptic Process Science & Technologies and Containment track, we will focus on the industry demand for innovations and safe and reliable technologies during fabrication. For the first time, we are launching a new session about Aseptic Process Science & Technologies with two important topics. First, Quality Risk Management of Gloves, which does allow a deep dive into the challenges and advantages that gloves in Barrier Systems provide. Gloves are always a topic of discussion from the regulatory authorities since they provide a certain risk to the product if they are not used properly. Quality Risk Management on Gloves will address critical areas of glove usage and how to avoid glove integrity failures and failures during operation. Second, Fast Surface Decontamination and Less vH2O2 Residues Inside the Aseptic Processing Barrier. Smaller batches, as well as new personalized medicines, require fast and reliable surface decontamination for safe Aseptic Processing with low hydrogen peroxide residues, which could interact with the pharmaceutical product. The scientific work on how to fulfill GMP compliance of robust and reproducible decontamination cycles will be explained.

2020 ISPE Aseptic Conference

Various case studies on highly hazardous/high potent operations will be presented during the two days of the conference from different companies like Fresenius Kabi, Oncotec, Gilead, Evonik, and Pfizer. The presentation from Fresenius Kabi provides a deep view of the process execution of two large filling lines for hormones and oncology products together with the compounding of the API. Multiple precautions have to be considered to protect the product as well as the operator. Cleaning requirements on surfaces within the fabrication of the aseptic product in Isolators and the operator protection during line set-up and operation will be the major topics discussed. The case study from Oncotec will be the second part of the session. In the meantime, Oncotec is running their high potent/hazardous filling line with robotics and the first lesson learns will be shared. Evonik and Gilead will talk about their modular aseptic fill and finish lines. Modularity and flexibility are keywords in aseptic processing. For small scale production and different primary packaging, maximum flexibility is required to meet patient needs. Both case studies will address this important topic. The presentation from Evonik does also includes a combined liquid and powder filling which provides a CMO the highest flexibility. Pfizer will offer another case study on aseptic powder operations with robotics.

Although I like all this scientific work and the case studies provided, my personal highlights of the Conference are the break-out sessions and the Group Round Table Discussions. This is the best way to talk about your specific concerns, challenges, and solutions with other companies and to learn from each other. For 2020 we have selected the following topics: surface decontamination with vaporized hydrogen peroxide, preventing cross-contamination and facility design for high potent/hazardous products.

The ISPE Aseptic Conference is the highlight for me in 2020 and I`m proud to be part of the Program Committee. I`ll do my best to serve your needs and interests on GMP, Science & Technology for Aseptic Processing during the 2 days and welcome you to join us and be part of the ISPE Aseptic family.

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