In the end, it all comes down to manufacturing the drugs on a commercial scale. Many challenges have to be overcome. This year’s aseptic conference has dedicated two sessions to manufacturing case studies. The first of these contains three case studies with very different requirements that must be solved. What they have in common is that they will lead the way for the future:

1) How to introduce a lifesaving vaccine as fast as possible by finding the appropriate approach through all the stages of manufacturing.

2) The filling of high potent drugs into syringes where established processes like outside washing (of the vial) cannot be applied.

3) Embracing the diversity of packaging materials on a multi-purpose fill/finish line for many different kinds of ready-to-use containers.

This session will provide state-of-the-art examples and tools for process control and quality risk management. Presentations will cover topics from Continuous Process Verification (CPV) to strategies for creating a holistic understanding of the quality system; and Annex 1 approaches to risk activities, including risk assessment tools that will enable the contamination strategy goals.

As the demand for new drugs and medicines grows, pharma continuously looks for new ways to increase productivity, strengthening reliance on automated equipment and robotics. The next decade will shape the Facility of the Future on Automation and Robotics. In this session, these trends will be discussed. A German CDMO will share how they transformed their gloveless Robotic Aseptic Filling operations to fully digital. In another case study, we will familiarize ourselves with automation for the aseptic processing support and a vial line with fully automated lyophilizer loading with robots. These exciting presentations showcase the leading-edge technology and development of automation and are excellent examples for the Facility of the Future on Robotics. The audience will leave with a better understanding of how to achieve better production while ensuring quality and patient safety.

Contamination Control Strategy is a key concept in the new Annex 1, but contamination prevention is not new to the industry. It covers all aspects of aseptic processes, starting with the selection of equipment, its qualification and routine production. But re-thinking of existing processes and retrofitting to improve them and introduction of new solutions to existing problems are also key. In this session, attendees will hear about a tool to select the right equipment, how Kaizen can be used to improve aseptic processes and how barrier systems are made even safer.

Aseptic manufacturing is a critical part of gene and cell therapy production, and these products are often very sensitive and require aseptic conditions throughout the manufacturing process. Many of these products are administered directly to patients, so it is important to ensure that they are free of contaminants and any baseline bioburden is not increased by the manufacturing process. This session will showcase examples that highlight the innovative approaches that were studied and implemented for operating multi-product facility, with the ability to do quick changeover between products. The case studies will span from starting/critical material through Drug Product and cover different jurisdictions .

In the second Manufacturing Case Studies session, participants will be presented with multiple smaller scale manufacturing approaches. Discussion on the challenges of scaling up gene therapeutics will be presented from an operator’s perspective. The conditions to facilitate the production of ATMPs will be analyzed by one manufacturer of quickly deployable cleanroom spaces. In addition to these cases, we will hear from a manufacturer who is really focusing on improving the human condition by making life saving therapies more accessible from a financial standpoint.

Annex 1, the European Union’s revised GMP requirements for the manufacturing of sterile medicinal products will take effect on 25 August 2023. As the document will also be adopted by PIC/S and WHO, the requirements become global. Companies will have to start preparing for implementation immediately. Key questions are: How to properly incorporate the principles of Contamination Control Strategy (CCS) and Quality Risk management (QRM) in sterile drug manufacturing? Do aseptic fill-finish operations in RABS and isolators need to be redesigned, based on the new requirements? And how can the new, more precise requirements in Aseptic Process Simulations (APS) aka Media Fills be implemented? The participants in this panel discussion have been intimately involved in industry’s commenting of the draft versions of Annex 1 and can therefore give background information and behind the scenes insights on how this document was developed.