FOYA Category Winner Presentations|
Get an in-depth look at the latest, state-of-the-art developments being implemented, the winning projects, and see how excellence was delivered through agility, collaboration, and innovative thinking. Featured presentations include the 2021 Facility of the Year Awards Program Winners.
Facility Integration - Takeda Pharmaceuticals International AG
Project: NINLARO The Grange Castle Factory P2 Facility
Operational Excellence - ElevateBio
Project: ElevateBio BaseCamp
Project Execution - Janssen Sciences Ireland
Project: BioCork2 – Large Scale Fed Batch Facility
Process Intelligence and Innovation - Takeda Pharmaceuticals International AG
Project: Packaging Building and Automatic Line Clearance
Social Impact - Government Pharmaceutical Organization
Project: Thailand Self Sufficient for Pandemic Vaccines; Influenza and COVID-19
Operational Agility: COVID-19 Impact - Gilead Sciences, Inc.
Project: Gilead Sciences, Inc., Center for Innovative Drug Research (CIDR)
Operational Agility: COVID-19 Impact - Grand River Aseptic Manufacturing
Project: Grand River Aseptic Manufacturing Large-Scale Fill-Finish Facility
Honorable Mention - Biocon Biologics Limited
Project: Biocon Biologics Manufacturing (B3) Project
Honorable Mention - Locus Biosciences
Project: Commercial Phage Production Facility Upfit
Honorable Mention - Raymond G. Perelman Center for Cellular and Molecular Therapeutics
Project: Raymond G. Perelman Center for Cellular and Molecular Therapeutics
As one of the fastest-growing and most dynamic companies in its industry, the Nephron Pharmaceuticals Corporation story is one of resilience and growth – through vertical integration and on-shoring PPE, Nephron has not only realized the importance of domestic manufacturing, but is actively taking the steps to create a real, and lasting solution. Nephron has turned within, utilizing cutting edge workforce development to create opportunities in technology, innovation and automation as we continue the construction of three new state of the art facilities, including a vaccination production wing, a Nephron Nitrile glove plant, and a COC syringe facility.
Concurrent Session: New Approaches to Process Agility and Reliability|Over the past decade the adoption of Pharma 4.0 technologies and the challenges of accelerating new therapies while meeting regulatory and business expectations for process robustness and reliability have driven new approaches in the industry. The sector’s accelerated response to the COVID pandemic was both enabled and sped up by these foundational innovations. This session will look at some of these responses and share the broader use of agile automation and data analytics to deliver more capable and reliable operations. The session includes a novel parenteral PAT case study that illustrates how the convergence of analytical and process technologies is delivering real value and ensuring a reliable supply of medicines to patients.
Concurrent Session: Fill Finish|This session will focus on technologies associated with the future state of Fill-Finish manufacturing. The presentations in this session cover 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.
Concurrent Session: Digital Innovation - Ensuring Quality and Regulatory Compliant Solutions|This digital innovation session allows attendees to discover how to cost effectively/efficiently validate and ensure the quality of their machine learning (ML) and software automation projects, while collecting and establishing the necessary evidence to withstand regulatory scrutiny. From a newly formed GAMP5 framework to computer systems/software assurance for automation, this session provides easily understandable and practical approaches behind the “mystery” of compliance for such novel digital technologies. Not only does the session give you tangible information to use in your next project, but it also breaks it down into the details you need. This includes ML as a sub-component of your overarching system(s), recommended risk-based life cycle deliverables, and right-sized scalable efforts to put your time and money where it matters most.
Concurrent Session: QRM/CQV - Best Practices and Lessons Learned|This session will address the development of standardized templates, application of risk-based concepts, and examples of implementation by Bayer and Amgen. In addition, the session will provide case studies demonstrating design with qualification in mind. Join the discussion and hear more about best practices, industry use-cases, and utilizing a system of lean integrated CQV.
Concurrent Session: Drug Shortages and Meeting Supply Chain Challenges|During the pandemic, supply chain issues and drug shortages were discovered across many industries, including biopharmaceuticals. Drug shortages have the potential to be one of the most impactful supply chain challenges to the health of people throughout the world and are a topic of significant interest to manufacturers, regulators, policymakers, health care professionals, and, most importantly, patients. The slow pace of post-approval changes can also impact the supply chain and has the potential to create drug shortages. While the purpose of post-approval changes is typically to improve the quality of the product by incorporating a new understanding of the drug or process, approval of these changes can take months or years. Using a Digitalization Toolbox beginning with Process Development and throughout the pharmaceutical lifecycle enables a flexible change management of the product through a robust Control Strategy. The optimal toolbox includes software and analytical tools to address knowledge management, holistic process understanding and the process monitoring and quality control across the development steps; a Holistic Control Strategy approach. This session will cover these topics and discuss how experiences with the COVID-19 pandemic provided an opportunity to further reduce drug shortages and improve the time it takes for post-approval changes to be implemented. Additionally, analytical models can help to maintain and manage complex supply chains from the start of development in order to shorten the time to patient. Finally, the session will open the topic of Holistic Control Strategy approach to increase processing efficiency and control across drug development.
Concurrent Session: Path to a Global Quality Dossier - Part 1|Industry has observed vastly different and region-specific CMC submission requirements and quality standards which can cause delays in approval of new medicines to patients worldwide. A related challenge is the differing global Post Approval Change requirements that can risk continuity of supply of medicines. The ideal state is a global quality dossier that can be assessed by multiple regulators and provides for a single, approved dossier that is globally maintained. This would allow faster access of medicines to patients around the world, reduce the risk of supply shortages, help resource constrained regulators to rely on each other’s expertise and provide less regulatory burden to industry. ICH Quality guidelines provide a firm foundation, and ICH Q8-Q12 outline key principles that cover product development by incorporating principles of risk assessments, pharmaceutical quality systems, and lifecycle management. In this two-part session, key aspects of a potential path to a global quality dossier will be presented. In part 1, presentations will focus on control strategy, a globally harmonized, risk-based quality overall summary and an update on Accumulus.
Concurrent Session: Increasing Facility Flexibility through Improving Turnarounds and New Product Introduction|The timelines involved in the introduction of new therapies often requires the creation of additional capacity while avoiding significant new capital investments. Maximising the productivity of existing assets is key to that response and the ability to reduce the time taken to complete cleaning and turnarounds can add real value. Similarly faster product introduction can be enabled through standardisation of quickly adaptable and adoptable single use process components and their associated automation systems. The three presentations in this session will share real world examples of companies delivering on those objectives and realising significant value.
Concurrent Session: Tech Transfer|This session will focus on three critical areas for successful tech transfer. The first presentation will provide insight to working with and establishing the right team for positive collaboration with a CDMO. The second presentation dives into a specific process and walks through steps to avoid common pitfalls in designing and transferring a cleaning process for manufacturing. The final presentation unlocks the concerns around continuous product and data flow from discovery through manufacturing exposing potential savings in time and costs. Concurrent Session: Tech Transfer|Concurrent Session: Tech Transfer|Concurrent Session: Tech Transfer| The valuable information will help ensure successful tech transfer and can lead to accelerated project timelines, waste reduction, and improve profitability.