Premier Association Sponsor: PDA
April 25 – 27, 2023
Javits Center, NYC

Stage 1 On-Demand Sessions

Stage 1 On-Demand Sessions

Unlocking value from Manufacturing Data using CPV, PAT, and converging innovations

Pharmaceutical companies generate massive volumes of data every day – all of which could become a strategic advantage for compliance, manufacturing, and new product introduction. But many struggle connecting data in a meaningful way to extract value like improvement in drug quality, streamlining new filings, and scaling new products. Additionally, most do not have a unified portal for analytics, nor interactive dashboards to signal optimal manufacturing setpoints. Our NextGen approach of rapid contextualizing of ALL enterprise manufacturing data across the spectrum – from real-time machine data to scanned batch records delivers a seamless cross-functional intelligence platform for CMC, quality, regulatory, technical operations, and data science. Value realization ranges from a) $1M - $4M in pre-commercial per product line to b) an ROI of $1M - $10M per plant per year using CPV and PAT.

Formulation and Process Development of Lipids, Polymers, and Nanoparticle Drug Products

The selection and manufacture of functional excipients is required to assemble the nanoparticles that are being used to deliver various payloads (mRNA, pDNA, etc.) for genetic therapeutics and more. In this presentation, we will dive into how these lipids and polymers are ultimately chosen based upon their characterization data, and then we will move into how the formulations are optimized, scaled up, and eventually moved into the cGMP environment to make finished drug product. From formulation to patient, we will examine the major unit operations and the data required to enable the next phase. With Lipid Nanoparticles (LNPs) set as the default drug delivery vehicle for mRNA, we will discuss why this is and other nanoparticle/nanocarrier alternatives, such as: exosomes, polymeric nanoparticles, suspensions, emulsions, and more.

Manufacturing in the age of disruption: trends, challenges, and the future

The life sciences industry is experiencing a major shift. Scientific breakthroughs. New ways of accelerating from R&D to manufacturing. New models for partnership and collaboration. A whole new mindset, which puts drug developers in favor of more innovation, more speed, and more flexibility in the name of more lives saved.

For that breakthrough science to mature into sustainable, commercial-scale operations, we need significant changes in drug manufacturing. In this presentation we will touch on different approaches to manufacturing such as high-density manufacturing, hyper flexible adaptable manufacturing, centralized vs distributed manufacturing and global deployment. Learn about trends and challenges associated with modern drug manufacturing and explore a fast and agile solution that reimagines the traditional GMP cleanroom to accommodate the future of manufacturing.

Drug Product from R&D to Product Launch: Addressing Supply Chain & Capacity Issues

Advancing a new drug product from R&D through to clinical trials and then on to product launch takes a lot of planning. Customize your approach with the latest information regarding capacities, trends, and approaches for an effective drug product productions (Formulation, Filling, and Packaging). Learn about impacts from supply chain disruptions, regulatory changes, and capacity constraints. Evolve your business for the different approaches needed for the many flavors of personalized medicine and how that is hugely different from biotherapeutics drug products, generic drug products, and vaccine manufacturing. For over 35 years, CRB has led the way in working with our clients' business cases to plan, design, procure, manage, integrate and build the facilities that produce drug products for your family.

Effective and Innovative Use of Digital Technology in accordance with Pharma 4.0™

The pharmaceutical industry has not always been quick to adopt new automation or digitalization technologies, but Pharma 4.0™ is quickly changing that philosophy. With realized benefits like minimized production downtime and increased throughput from predictive analytics, eliminated reliance on repetitive-task human labor through robotics, and reduced facility footprint needs from mobile and cloud technologies, there are mounting business cases taking Pharma 4.0 mainstream. However, creating a sustainable, value-led approach that meets regulatory oversight and valid security concerns is critical in the successful adoption of new technology within your manufacturing process—so how do you get there? What does a practical roadmap to digitalization look like? And how does the implementation of digitalization impact the design of your facility?

This presentation will guide listeners to create their own informed, value-led path toward digitalization. Additionally, we’ll discuss questions and goals that lead to a strong 4.0 strategy as well as provide a comprehensive overview of the current state of Pharma 4.0 possibilities.

Next Steps for Lean Lab - Real-Time Testing of Pharmaceutical Water for Production

Online water monitoring has become prevalent in the pharmaceutical and biotechnology industry to provide a real-time measurement of water quality; however, in order to release water into production with an online instrument, the online water monitoring system must be properly validated in accordance with compendial requirements for real-time testing (RTT). Current state laboratory practices and online monitoring require the isolation of grab samples for compendial testing and release. This introduces the potential of contamination and delays the release of water into production. RTT eliminates these inefficiencies, saving pharmaceutical and biotechnology companies time and money.

To implement RTT there are various elements that must be considered to build quality by design into the process and mitigate patient risk, process risk, and business risk. This discussion will provide insight into the elements necessary for validation and successful implementation of RTT.

The Future of Aseptic Connections in Cell and Gene Therapies

In a market where efficiencies, cost savings, repeatable processes and safety are vital, cell and gene therapy companies must routinely evaluate their processes and analyze where improvements can be made, even down to the way they are managing fluid transfer.

In the presentation, we will examine the total cost of ownership of tube welded connections and single-use aseptic connectors. Evaluating criteria such capex, raw materials and utilities but also layering deeper into considerations such as training, downtime, validations, and connection speed.

Comparability Study Considerations for Cell Therapies

Cell therapies, while inherently complex, have a great potential to advance quickly through clinical trials, and because of this, it is important to apply lifecycle requirements much earlier than other biologic products. Because of the inherent complexity of cell therapies, fast track approval paths, and the need to optimize processes as new data becomes available, it can be a challenge for drug developers to establish comparability plans that address regulatory requirements. One of the keys to ensuring success is a defendable, scientifically justified demonstration that process changes are applied in a controlled manner that preserves the integrity of the product. In this session, we will explore what comparability means for cell therapy, the regulatory requirements to help us ensure success, and strategies for ensuring a clear path to approval for these products. In the context of fast track success, it is important to establish good science so that our patients can benefit as soon as possible.

Developing a Pragmatic Disinfection Program – Beyond the Cleanroom Core

Day to day operating costs for pharmaceutical manufacturers are high due to the highly regulated cGMP environment they must operate in. The risk of getting things wrong can also be catastrophic. Companies must therefore determine the best activities for disinfection for their facility. Whilst impacting on operational efficiency, the benefits from a good contamination control strategy include robust approach to disinfection, operator safety and consistency of quality in production.

Being aware of and reducing negative impacts from disinfection approaches should also be a priority and these include application restriction of hazardous chemicals, reduction of chemical residue, and limitations of chemical over usage.

This presentation shares a pragmatic disinfection program for cleanroom areas beyond the aseptic Grades A and B, accounting for risk determination and sound science, adequate cleaning, good disinfectant application tools and skills, environmental awareness, and safety.

Delivering on Virotherapy Manufacturing Capacity – Considerations for Facility Design and Project Execution

The market for viral therapies is expected to see a double digit compound annual growth for the next five years. To meet the market demand, viral vector manufacturing capacity is projected to grow at a rate of 18.5%. In this presentation, we will discuss building capacity to support live virus and viral vector production versus working with manufacturing partners with state-of-the-art facilities.  We will discuss specific facility design considerations and modular approaches to delivering on the capacity need.  The focus of the presentation will be a case study that highlights a state-of-the-art virotherapy manufacturing facility completed in just 13 months, due in part to the use of modular pre-fabricated clean rooms.

Implementing Membrane-Based Water for Injection Production

Since the mid-1800's Water for Injection (WFI) has been produced via distillation; a reliable but heat-intensive and costly process that was mandated by pharmacopeias across the globe.

Technology evolution, beginning in the 1970's and in subsequent decades, resulted in our ability to dependably produce WFI using alternate, less costly, methods. However, the world-wide pharmaceutical community was unable to reach consensus that would allow these new techniques to be widely utilized. Recently, the European Pharmacopeia approved the use of membrane technology for WFI production. This change created a harmonization between the United States, Europe and Japan leaving the Chinese Pharmacopeia as the only major pharmacopeia still requiring distillation. WFI created using membrane technology is an important change that can have a huge impact on facility optimization efforts since, in many instances, it can significantly reduce the demand for steam and chilled water at sites that rely on WFI.

Advancement in Bioprocess Film

Bioprocess film is one of the critical components for bioreactors, mixing vessel, media and product storage containers etc.  The presentation reviews the challenges in bioprocess film development and manufacturing, and how they may impact the performance and application results of bags and containers.  Comprehensive design and development approaches of a new bioprocess film are discussed to address the pain points of current bioprocess film applications.  The performance and benefits of the bioprocess film to end users of bags and containers are delivered through technical data and risk based assessment approach.