iSpeak Blog

Aseptic Project Execution: Impact & Responses to COVID-19

Keith W. Weseli, CPIP
medical Syringe

It was March 2020 and my first year serving on the ISPE Aseptic Conference Planning Committee. I was brimming with excitement of the possibility to introduce speakers and facilitate discussions at this conference I had enjoyed and learned from multiple times as an attendee. Little did I know how much I would get to participate, as my fellow committee members were restricted from traveling to the event. All this due to the spread of the coronavirus. During the conference, I learned the correct way to greet an adult is with a fist bump. With videoconferencing capability and some scrambling, we were successfully able to provide the in-depth technical information and knowledge-sharing that everyone is accustomed to with the ISPE Aseptic Conference.

Our society has experienced an unprecedented amount of uncertainty resulting from the COVID pandemic. I share this small example above from the beginning of the pandemic to highlight how small that problem looks in retrospect. As someone who has spent most of his career delivering projects to increase and/or upgrade pharmaceutical manufacturing capability, I (among many others) was concerned that projects would grind to a halt. As we all know (now), the pandemic became our industry’s call to arms and accelerated the demand for the potentially lifesaving products our industry produces in improving the human condition and the projects that facilitate these solutions in parallel.

2022 ISPE Aseptic Conference

At the upcoming 2022 ISPE Aseptic Conference, I will have the distinct privilege of leading a session with two presentations dealing with project execution during the pandemic. With long lead times now the norm, as a side effect of the pandemic and the need to maintain uptime, owner companies may elect to utilize and upgrade existing facilities and equipment, rather than purchasing new. Les Edward, Vice President and Business Development and Brian Smith, Director of Project Management, both of SKAN US will deliver a case study on retrofitting a Restricted Access Barrier System (RABS). In the case presented, production downtime had to be minimalized. With this goal known going into the project SKAN and the user company developed innovative solutions by combining their regulatory expertise, process, equipment knowledge, creativity to design compliant upgrades for the future and to ensure higher sterility assurance levels. SKAN engineered and installed (3) RABS retrofits to the existing productions line. Each line was a different layout with different features that required different solutions. Their combined experience in aseptic manufacturing, current and new Aseptic Guidelines allowed them to design unique features on each line. I will be looking forward to the hearing the design solutions that facilitated ergonomic operation and airflow while minimizing overall facility downtime. Certainly, utilizing existing facilities and equipment is faster from a supply chain standpoint, but often presents design challenges that are not fully understood until the implementation phase. Hearing these solutions from the equipment designers’ perspective will certainly be fascinating.

The second presentation will be equally captivating. Society demanded the availability of COVID vaccines as soon as humanly possible. This required novel approaches to minimize the time to market of these products’ society was counting on. Andrew Spasoff, Senior Director Quality from AstraZeneca will lift the curtain on vaccine development, with his presentation “Pre-PPQ Vaccine Lots - They Weren't So Crazy After All.” Normally, any lot manufactured prior to the start PPQ could not be used for commercial distribution. Since the COVID-19 pandemic was not normal, AstraZeneca developed a novel approach to overcome the challenges of short development and tech transfer timelines to speed safe and efficacious vaccine doses to patients. Andrew’s presentation will discuss compliance, GMP and regulatory considerations that were fundamental to the success of this approach. We will all get a chance to learn about the challenges AstraZeneca faced, internally and in interfacing with global regulatory bodies and their expectations. Most importantly, the presentation will outline how a similar approach could be utilized for future vaccines and therapies.

These two presentations are just a small sample of all the content that will be available for attendees to delve into over the two days in Bethesda in just a few weeks. Technical presentations on robotic solutions to aseptic processing will be another set of “can’t miss presentations.” We will hear about the technological advances that align with the expectations of the forthcoming EU GMP Annex 1 revision. Specifically,

  • Eliminating the risk of humans by implementing automated monitoring technologies and RMM
  • Executing PUPSIT with a multi-purpose flexible gloveless robotic filling line
  • Using robots to replace human operators
  • Applying quality by design approach to meet a holistic contamination control approach

The regulatory roundtable is also a consistent highlight for me. The FDA will be represented along with multiple OUS regulators. The forum allows the regulators to truly dialog with industry and be extremely transparent on trends and expectations. It an opportunity that the regulators have historically been extremely “real” with the audience, allowing attendees to take back real time trends for their companies to consider in their facilities.

I really hope I will see you in Bethesda on March 14-15th!

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