iSpeak Blog

Agility & Innovations in Process Development and Manufacturing

Charlotte Enghave Fruergaard, PhD
Agility & Innovations in Process Development and Manufacturing

The needs of patients must always be at the forefront of what we do.

Many of our colleagues are taking on the challenge of rethinking the old ways. They are collaborating with each other and the regulatory agencies to take effective steps to remain at the forefront of regulatory science and innovation. Why? In order to ensure the continued delivery of effective medicines.

As we consider the future of pharmaceutical process development and manufacturing, we must use Agility to identify the emerging needs of patients, assess the impact of these needs to foster Innovation within process development and manufacturing, and develop good practices in Collaboration. In addition, there is also a need to be intentional: to shape the knowledge management landscape and recognize the inherent culture changes required to be agile in today’s world. Especially with our “changed” world affected by the COVID-19 pandemic, this becomes even more important.

2021 ISPE Annual Meeting & Expo

There are several emerging trends in pharmaceutical process development and manufacturing that will ensure that we can continue to deliver effective medicines to meet the needs of the patients. Moving into the future we need to consider advancement within Aseptic Facilities and Tech Transfer and using Control Strategies, Data Analytics and AI to reduce risks and enhance quality. The Process Development and Manufacturing Track will cover these topics and more at all stages of the product lifecycle.

There are countless aging sterile injectable facilities around the world that continue to operate on the edge of regulatory failure. They continue limping along for years, squeezing though audits based on extensive data reviews and the application of increased procedural controls. Upgrading or improving these facilities and equipment is paramount to meet today’s sterile injectable manufacturing standards. There are five Process Development and Manufacturing Educational Sessions at the 2021 ISPE Annual Meeting to educate and inspire discussion about this topic.

One session will cover both the regulatory risks and potential consequences with aging facilities as well as how to create a business case to justify the need for the facility or equipment upgrades.

Another session will focus on technologies associated with the future state of Fill-Finish manufacturing covering a wide variety of technologies such as innovative processes using modern technologies and intelligent modular concepts, the development of an innovative cGMP-compliant and flexible production cell based on isolator technology, and technological highlights to cover major challenges for the aseptic handling of viral vaccines under BSL2. Three different projects pushing the boundaries of Fill-Finish to show Agility, industry Collaboration and successful Innovation in new technologies will be presented.

A successful tech transfer is crucial for getting quality products to the patients. Three different presentations will cover Tech Transfer and share valuable information that can help to ensure successful tech transfer and can lead to accelerated project timelines, waste reduction, and improve profitability.

The Control Strategy has become more and more important and many different control strategies must be effectively designed, developed, and implemented to secure robust manufacturing and product quality throughout the product’s lifetime. The label ‘Control Strategy’ is used widely and for different purposes. This session will focus on Control Strategies and on demystifying the difference between control strategies as well as understanding the impact of modern DoE and how the maturity of control strategies supports fast, robust, and seamless batch and continuous product manufacture in a connected and digital world.

Check out the Process Development and Manufacturing Track at the 2021 ISPE Annual Meeting & Expo to see what we have in store.

Agility. Collaboration. Innovation.

Register Now!