iSpeak Blog

Balancing Speed and Quality: Strategies for Excellence in Life Sciences Manufacturing

Niranjan S. Kulkarni, PhD
Amanat Kaur
Robert E. Perks, MSc, CEng
Ryan Paul Mazur
AM23 Audience

As with all aspects of our life sciences industry, understanding how we can best meet the needs of patients with the timely delivery of life saving and sustaining products is of paramount concern. During the years since the global pandemic, the expectations and pressures on the pharmaceutical industry with respect to development, speed to market, quality and sustainability have increased exponentially — all while maintaining, or preferably reducing, the cost of goods. This year’s Manufacturing, Quality Control (QC), and Operational Excellence content track aims to address some of the many components that go towards realizing those expectations.

As always, the presentations will provide perspectives from pharmaceutical manufacturers, integrators, product developers, and vendors with specific case studies that can be applied or transferred for pertinent applications. The sessions will improve attendees’ understandings of the technologies available in the marketplace; showcase examples of real-life implementations; share experiential lessons learned, and provide the opportunity to meet, question, and learn from others in the industry.

The sessions in this content area are focused on:

Reliability and Quality

The first session of the Manufacturing, QC, and Operational Excellence content track will explore various aspects of reliability in medical products, specifically combination products. The presentation will cover key aspects of reliability and operational efficiency in pharmaceutical manufacturing, emphasizing the importance of integrating reliability engineering throughout the lifecycle of medical and combination products. From initial user needs to product design, risk management, and continuous improvement based on patient feedback, reliability is essential for ensuring product performance and patient safety. The session will also provide an opportunity to understand the latest thinking around the implementation of advanced analytics for alarm management and prioritization and demonstrate how advanced analytics can be used to consolidate and optimize alarm handling, enhancing operational efficiency and fostering global collaboration. The last session will focus on how digital and AI tools can add a new dimension to the quality decision making process.

Leadership and Culture

In order to achieve operational excellence within any area of the industry, leadership must understand and champion the cultural transformation required to address the rapid changes necessary to meet the new paradigms of the industry. An organization's culture is crucial for success in changing environments and globalization, with cultural transformation yielding significant returns on investment. New technologies, processes or procedures are not implemented in a vacuum. They are about the leadership and cultural changes required for their successful implementation. Effective cultural change requires strategic planning, emphasizing growth, loyalty, innovation, and employee happiness. The new paradigms in manufacturing also require a deep understanding of the impact on the workforce, the personal engagement, and leadership required to make lasting improvements.

Presentations titled “Leading a Culture of Collaboration and Growth,” “The Human Side of Manufacturing,” and “Impactful Technical Leadership in a Changing World” will explore the human side of manufacturing and operational excellence and the requirements to lead and train the workforce of the future.

Facility Design

Facilities must be state of the art — even though the facility design is changing faster than facilities can be built or retrofitted. Facilities must by product-specific but also flexible, low cost, environmentally sustainable, expandable, and efficient.

State-of-the-art facilities implement the latest technology, offering extensive multi-product capacity and flexibility to future-proof its manufacturing capabilities for products currently under discovery and development. All of this is accomplished with the latest GMP standards and good engineering practices, ensuring a commitment to patient safety. The session will address some of these topics with presentations and discussions from experts in facility design.

This session “ISPE Baseline® Guide for Oligonucleotide Facility Design,” presented by three of the document’s authors, will provide an introduction to the new ISPE Baseline Guide. Attendees will learn how significant increases in commercial approvals for the oligonucleotide modality over the past five to seven years have resulted in a subsequent increase in production capabilities, especially batch sizes.

The last presentation in this facility design-focused session will cover the merits of ballroom and connectivity concepts in facility design. Many biopharmaceutical companies are conservative, perceiving high regulatory risks in designing open ballroom facilities with closed processing, especially for simultaneous multi-product manufacturing. A case study will be presented that demonstrates a fully open ballroom concept with process closure, supported by comprehensive risk assessments and data.

2024 ISPE Annual Meeting & Expo

AI and Digitization

The session “AI/ML Strategy and Opportunities in Pharma Tech Ops” will delve into the ever-expanding opportunities for artificial intelligence (AI), machine learning (ML), and digitization in the industry. The case studies for all these revolutionary concepts have grown exponentially as the industry realizes that these game changers are no longer nice-to-have options — they are necessary to improve product quality and manufacturing excellence. The first presentation will share insights into the journey of integrating digital transformation, advanced data analytics, and operational excellence, with a particular focus on AI/ML, which has been strategically pioneered to deliver significant business value. Specific AI/ML use cases including predictive and adaptive manufacturing process controls, scheduling optimization, and generative AI (GenAI), will be explored. The challenges and opportunities of applying AI/ML in the evolving, regulated pharma industry will also be addressed.

The second presentation, “Data Integrity (DI) by Design through Automated Data Capture Strategy,” will demonstrate an implementation model for a policy mandating automated data capture for all GMP output data. Such a model involves assigning DI classifications, aligning instruments to these classifications, assessing instruments based on vulnerabilities like falsification and pre-testing, and addressing any gaps. The audience will be exposed to challenges incorporating this approach in existing facilities and the successes in designing data integrity controls into new processes and installation.

The last presentation, “Digital Twins and AI in Biopharma Manufacturing,” will showcase cutting-edge concepts of federated digital twins and AI, where interconnected digital twins share data, insights, and learning. This creates a holistic virtual representation of biopharma operations and their critical business parameters, enhancing predictive analytics and operational efficiency across multiple facilities. This forward-looking perspective on the integration of digital twins and AI demonstrates how these technologies drive innovation, efficiency, and excellence in biopharma manufacturing.

503B Compounding

There is a growing interest in 503B Compounding. “Panel: 503B Compounding and ISPE Guide” will feature an expert panel discussing 503B compounding with an introduction to the new ISPE Guidance Document on the topic. The audience will be exposed to practical aspects of implementing a robust deviation and investigation program for compounding pharmacies as well as gain actionable insights into effectively managing compliance, navigating challenges, and maintaining high-quality standards. The panel will also cover regulatory perspectives that shape 503B compounding practices, offering valuable viewpoints from seasoned professionals on current regulations and their impact on the industry.

This session is designed for professionals at all levels of pharmaceutical compounding, regulatory compliance, and quality assurance, ensuring that attendees from various backgrounds can benefit from the insights shared. The panel aims to foster a deeper understanding of the intricacies involved in 503B compounding, providing expert guidance and practical strategies for navigating this complex field

Everyone is encouraged to attend these informational sessions and interact with the presenters and colleagues. ISPE looks forward to seeing you at the 2024 ISPE Annual Meeting & Expo in Orlando, Florida.

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