Opening Plenary Session | In this opening session, representatives from FDA and from industry will give their high-level perspective on where the Pharmaceutical Industry is heading. The COVID-19 crisis saw drastic changes in the way of working, but also tremendous efforts from the pharmaceutical industry to develop therapies and vaccines for SARS-Cov2 infections. Rapid development, commercial upscaling and distribution are needed to deliver to the patients. Ways of working need to be rethought, procedures developed and implemented at high speed.Session Leader(s):
Intersection of ATMPs and New Technologies | Advanced Therapy Medicinal Products (ATMPs), are medicines for human use that are based on genes, tissues, or cells. ATMPs offer novel ways to treat a variety of diseases, and in some instances can be curative. As ATMPs move out of the clinic and become commercialized, manufacturers face traditional challenges of scale-up, transfer and the application of new technologies. This session will explore this intersection. You will hear from experts in the field who will provide valuable technical insight and case studies to the participants.Session Leader(s):
The ISPE Student Chapter (SC) Munich is currently working on an industry project named "Biosafety Project" together with all other ISPE D/A/CH Student Chapters. The aim is to develop a guideline on how to define organizational and technical measures for keeping the operator and environment safe when manufacturing cell and gene therapies (CGT) - whilst fulfilling GMP requirements at the same time. In the first presentation the current work of the team regarding Biosafety requirements and implementation is presented, current obstacles are discussed, and future steps are shown. Operator Safety was one of the major goals to combine the flexibility to handle liquid and lyo products with fully isolated equipment, to guarantee the highest degree for a BSL 2 Viral Vaccine Fill and Finish Facility. The major hurdles from a project execution perspective will be presented from Bavarian Nordic/CDMO.Session Leader(s):
Facility Considerations for Next-Generation Manufacturing | Facility Considerations for Next-Generation Sterile Product Manufacturing | The rise of advanced therapy medicinal products has taken the industry by storm over the past few years. This session will look at the engineering challenges that these products present to facility designers and operators. Flexibility is a key with the reduced batch size associated with these products. This session will address how this needed flexibility can be designed into ATMP manufacturing facilities.Session Leader(s):
Containment - Understanding Why, When, and What Regulatory Agencies Expect | For10 years - the Risk Based Manufacture of Pharmaceutical Products has defined expectations for cross contamination control to protect patients. Understand what cross contamination control: why it is needed, when it is needed, how to determine the extent of what is needed, and what the regulatory environment is regarding cross contamination control to protect patients. This protection translates into requirements to also protect operators.Session Leader(s):
Revision of EU GMPs Annex 1: What Impacts Can We Expect as an Industry? | 2020 saw the commenting of the draft Annex 1, which included many changes to the 2017 version. In this session, we will cover the commenting process both from the ISPE and the PHSS perspective. Selected topics will be discussed in detail. Based on the outcome of the session with regulators from the 2020 ISPE Annual Meeting, we will give an outlook on the implementation of the final guidance issued by EMA.Session Leader(s):
H2O2: Not the Same Old Topic | H2O2 decontamination has evolved over the years. As aseptic processing has progressed within isolators and within operating rooms, H2O2 has evolved to be used not only as equipment decontamination but also as room decontamination. As ATMP processing has progressed in the past few years, H2O2 has taken on new importance. How should you use H2O2 and what do you need to understand? This panel knows.Session Leader(s):
Modular Robotic Fill/Finish Lines | The use of robotics is a hot topic in pharma, particularly in the area of fill/finish. While robots are able to accomplish numerous tasks, in aseptic processing, their use is primarily for container handling or replacing a classical transport system. They provide very smooth individual transport and, from a line perspective, a completely modular approach. More and more experts are claiming this is not enough. Robotics can and should do more like settle plate handling, trouble shooting, gloveless operation, quick change over, easy efficient cleaning/washing, increased product and operator safety to name some of the possibilities. The need for expanding the use of robotics into a variety of functions was a key topic of discussion during last year’s Aseptic Conference. This year’s session has been designed to continue that conversation and learn from industry experts who are moving forward with implementation.Session Leader(s):
Single Use Technologies - Are they sustainable? | Over more than two decades, the pharmaceutical industry has increasingly adopted single-use technologies primarily to simplify manufacturing and seemingly to reduce cost; however, the need to reduce environmental burden has a huge impact on these facilities. This session will focus on single-use technologies for gene and cell therapy facilities, while considering the impact on sustainability.
Our first presenter will investigate the impact of single-use with respect to proper cleaning, disposal, and handling, and how it relates to vaccine production including Industry 4.0 and implementation of the 6R's.
Our second presenter will discuss the unique nature of Advanced Therapy Facilities including the advantages and disadvantages of single-use and modular clean room technology as well as flexible manufacturing for gene and cell therapies.
Process Safety | Robust and safe processes are the foundation of pharmaceutical manufacturing. Changes to processes are inevitable, but often result in increased risks. New processes such as those associated with changes in raw materials or transfer of production to other sites have to be managed properly. In this session, two different examples will demonstrate which methods and structured approaches can be used to effectively maintain process safety, even when they involve major changes.Session Leader(s):