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Conquering Challenges of 21st Century Small Batch Clinical Aseptic Manufacturing

Keith W. Weseli, CPIP
Conquering Challenges of 21st Century Small Batch Clinical Aseptic Manufacturing

The world is getting smaller due in no small part to the technological advances. Pharmaceutical Manufacturing is moving in parallel with this trend—smaller batch sizes and personalized medicines are the trend on the horizon. But some producers, small has always been their business.

The 2020 ISPE Aseptic Conference March 2-3 at North Bethesda, MD will offer attendees some several unique perspectives and case studies across three separate tracks. On Tuesday March 3, 2020, the Aseptic Track will present three separate case studies that tackle the challenges that producers in the clinical sterile manufacturing world must overcome. Small scale manufacturing must be flexible and efficient, making the most of limited resources. These manufacturers have different requirements than full-scale, commercial manufacturing, but ultimately need to fulfill the same standards concerning aseptic handling. Prime examples of this are the compounding pharmacies, academic institutions and hospitals. This session will look more closely at the challenges faced for these operators and will explore the solutions that they found. Come hear about how Teva and the University of Iowa implemented project solutions to serve the needs of their diverse client base. Learn how 503B compounding pharmaceuticals overcome hurdles to regulatory compliance.

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Technology is one means of achieving this flexibility these small-scale manufacturers’ business models demand. Flexible filling technologies will be examined in the context of a fast-tracked project case study. The facility owner will share their lessons learned in implementing flexible filling and three years of production with this technology. In this case, the project resulted in the company having end-to-end manufacturing capability in one facility. Clinical biological production, cell banking, bulk production and final filling is all under one roof giving the R&D organization ultimate flexibility. This presentation will demonstrate how engineering, technological solutions and a modern Quality Risk Management approach allowed the project to be delivered rapidly—less than 12 months between equipment on site to the completion of initial qualification aseptic process simulations (media fills).

The second case study is also focused on implementing a science and risk-based approach to qualify the equipment implemented in for a phase 1 / phase 2 clinical manufacturer. This project is using multiple fill lines and separation schemes to deliver multiple flexibility for their over 80 customers, consisting largely of small and virtual companies. Batch sizes can be as small as 500 units, which allowed the owner to serve this niche customer population that was often overlooked by larger CMO/CDMO organizations. The new facility involved in this case study allows the presenting organization to move from traditional aseptic filling to fully automated isolated filling, with vaporized hydrogen peroxide decontamination of the isolators and the rooms. The project team is utilizing the verification approach espoused in the recent release of Revision 2 of ISPE Baseline Guide 5, Commissioning and Qualification. Attendees will learn how this project is utilizing equipment vendor testing protocols and execution support to trace through a requirements traceability matrix to full qualification requirements to focus the verification effort and allow the physically disparate project team stakeholders to deliver for the owner. The legacy facility has to be kept in operation until the new facility is suitable for production—presenting unique challenges to the design and operation team that will be shared with the audience.

The tragic events of 2012 at New England Compounding heightened the regulatory scrutiny associated with compounding pharmacies, as state pharmacy boards were proven to not have the ability to properly regulate these operations which have the potential to endanger public health. 503B compounding pharmacies are those outsourcing facilities which manufacture large batches with or without prescriptions. This additional manufacturing capacity eases some of the pain of the healthcare system struggling with drug shortages. However, the entrants into the 503B compounding space are not traditional manufacturers and are not accustomed to the rigors of current Good Manufacturing Practices or holistic quality systems.

Attendees will hear a final case study in this session that will address some of the challenges that these organizations have faced in implementing the controls and practices necessary for regulated manufacturing. Manufacturers take procedural control, aseptic technique, cleaning practices, documentation practices for granted—not so for 503B compounders. The presentation will show how one compounder implemented these basic quality practices to make the regulatory transition successfully.

You will not want to miss the learnings presented by these three separate but related owner/operators this coming March.

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