PDA Week 2025 Posters

Artificial intelligence (AI) continues to evolve and propel businesses forward; however, the Life Science industry’s adoption of these technologies is delayed in comparison with other industries. AI technologies have the ability to greatly reduce cost and time to market of products, especially when applied to and integrated with the process validation lifecycle. Due to the nature of the highly regulated industry, these technologies also introduce a number of challenges to the industry, particularly when it comes to validating these solutions. This presentation aims to demonstrate how developing AI solutions integrates with the process validation lifecycle, while demystifying some of the nuances around various AI solutions and terminology. It also works to lay out comparisons between AI, multivariate statistics, and traditional Continued Process Validation (CPV) methods; highlighting the benefits of each and use cases where each solution may be preferred.

There is an understanding of how cleaning processes for pharmaceutical equipment used in aseptic operations are implemented not only for controlling drug product cross-contamination, but also for the initial reduction in bioburden prior to sterilization. However, there is limited guidance on bioburden limits for product-contact surfaces on equipment used to manufacture non-sterile products. This lack of information and regulatory requirements prompts questions on whether it is necessary to have a separate sanitization or disinfection step after cleaning of equipment product-contact surfaces for nonsterile drug manufacturing. Per USP  < 1115>, microbial limits and the design for cleaning and other associated processes should be based on risks assessed and the level of control necessary based on the product. It would be beneficial to implement processes that can address both product residual and microbial contamination of equipment surfaces. Multiple factors play into the design of an effective and efficient cleaning process. When adequate controls are implemented for the cleaning process and its associated factors, a separate sanitization or disinfection process may not be needed for product-contact surfaces when data is able to demonstrate that the cleaning process and the other preventive measures are able to control microbial contamination of those surfaces.

As the use of imaging devices and artificial intelligence (AI) gain traction in culture plate reading, the question of performance on detection of mixtures of organisms often arises. This is typically borne through traditional thoughts of validating alternative quantitative methods for micro-organisms to ensure methods do not demonstrate any interference or bias towards organism recovery or detection. This approach, however, may not be applicable to newer technologies. In the case of the APAS Independence, an AI-based culture plate reading system, testing of bacterial mixtures is not necessary. The system is designed to detect both bacterial and mold colonies ,with each colony being classified as a result of pixel level detection in an independent and uninfluenced manner. The pixel result is entirely based on the way the algorithm is developed, which remains agnostic to any species identification within bacterial or mold groups themselves and only requires differentiation between these groups at a high level.This poster will provide insights into imaging and AI-analysis tools to demonstrate how mixtures of organisms are detected, highlighting the independent nature of colony assignment. If the segregation of mold and bacterial colonies is important, additional specificity testing may be considered.

The shortage of skilled workers in the pharmaceutical and biotech sectors has become a significant barrier to industry growth and the success of new companies in local areas. Without a reliable talent pool trained in essential industry standards, companies struggle to meet regulatory requirements, operate efficiently, and scale their operations. This challenge highlights the pressing need for a collaborative approach between educational institutions, economic development organizations, and industry leaders to develop a steady supply of skilled professionals.

A key solution to this issue has been the implementation of GMP (Good Manufacturing Practices) Bootcamp programs, where industry leaders and colleges partner to offer hands-on training in foundational GMP concepts. These programs are designed to benefit new graduates, career changers, and others seeking stable, well-paying jobs by equipping them with skills that are immediately relevant to the pharmaceutical and biotech sectors. For companies, hiring workers already trained in GMP standards shortens onboarding times and reduces training costs, while local economic development groups benefit from a talent pipeline that attracts industry investment and fosters job growth. This collaboration not only addresses the skilled labor gap but also supports regional economic development by creating attractive, sustainable career opportunities in these growing sectors.

The R&D Quality (RDQ) Internship at Kite Pharma provided me with a comprehensive introduction in ensuring compliance with health authority regulations and fostering a quality-driven culture within clinical research and development. Key contributions included preparing for regulatory inspections by reconciling clinical trial timelines, conducting gap analyses, and developing mock inspection documentation. I also supported Standard Operating Procedure (SOP) updates to enhance consistency and developed engaging training materials, such as the Quality GCP Training Game, to strengthen employee understanding of Good Clinical Practices (GCP) across departments and functional areas. Additionally, I conducted a training gap analysis to assess current GCP audit report writing skills and support the future creation of team training materials. Overall, this internship reinforced the importance of quality in protecting patients, ensuring product reliability, and managing risks in the development of innovative therapies, and further fueled my interest in the field of Quality.

Chlorine dioxide gas (CD) sterilization is an alternative modality to ethylene oxide as well as other sterilization modalities and is of high interest to the EPA and FDA due to both its sustainability as well as effectiveness.  The dry method of generating chlorine dioxide gas was developed within Johnson and Johnson and generates a greater than 99% pure form of chlorine dioxide gas.  CD gas is an oxidizer which is non-carcinogenic, non-explosive at use concentrations and can perform sterilization at ambient temperature. The presentation will discuss the elements that need to be considered when selecting packaging for a product being sterilized with chlorine dioxide gas.  It includes an explanation of what packaging is most suitable for certain product categories as well as packaging suggestions for products with unique restrictions such as absorbable products.  The poster will also include expert analysis from material manufacturers on test data on the suitability of chlorine dioxide with their materials.  Additionally, residual levels and cytotoxity is analyzed to further indicate compatibility after processing.

A comparative study of Polysorbate adsorption to membrane filters for Fill & Finish applications, considering a potentially upcoming restriction of the use of PFAS based membranes, such as PVDF.

Navigating the complexities of compliance in the biopharmaceutical landscape—particularly for cell and gene therapies—requires innovative and effective solutions. In response to these challenges, Syner-G | Sequoia have developed a Quality Risk Management (QRM) Playbook aimed at standardizing and enhancing the adoption of quality and risk management practices across global operations. This Playbook ensures operational excellence through streamlined processes, advanced technologies, and an engaged workforce;One of the key benefits of implementing this Playbook is a transformative shift in organizational culture towards a proactive QRM approach, fostering a collective sense of quality and ownership among teams, particularly in multi-site environments. This cultural evolution not only reduces the risks associated with drug development but also redefines compliance activities by highlighting their critical role in ensuring patient safety. By embracing a practical and effective methodology to quality risk management, organizations can reshape compliance from a perceived obstacle into a strategic advantage, leading to better outcomes for the business and improved patient care.This poster will discuss how the QRM Playbook empowers teams to refine their compliance strategies and advance their drug development initiatives.

The pharmaceutical industry is constantly evolving, driven by technological innovations aimed at enhancing efficiency, quality, and adaptability in drug manufacturing processes. This presentation highlights the success story of flexible fill and finish platforms over the past decade and introduces groundbreaking advancements shaping the next generation of pharmaceutical manufacturing, such as new container transfer solutions and the next generation of isolated pharma machinery. It also includes regulatory aspects like EU GMP Annex 1 and addresses the requirements relating to novel medicinal products and their individual properties. By exploring these technological advancements, the presentation aims to provide insight into the transformative potential of these innovations in optimizing drug manufacturing processes, ensuring product quality, and meeting the evolving demands of the healthcare landscape.

Analytical testing and an appropriate sampling method are instrumental in confirming that equipment surfaces have been adequately cleaned during cleaning validation or verification activities. Surface swab sampling is performed manually by directly holding the swab (hand swabbing) or attaching the swab to the end of an extension pole (remote swabbing). This study evaluated the performance of a prototype automated swabbing device constructed from configurable microcontrollers, microelectronics, and electromechanical components against representative manual sampling methodologies.Automated swab sampling of pharmaceutical manufacturing equipment offers several advantages over hand swabbing or remote swabbing, including decreased variability, the necessity for swab qualification of operators, increased accuracy versus remote swabbing, and decreased risk to personnel. To determine if automated swabbing can replace the current state of the art in manual swabbing, The Hyde Analytical Laboratory performed a comparative analysis of manual swabbing methods, hand and remote, and an automated swabbing method using a prototype device developed by Swabbot Solutions. This case study tested the three swabbing methods using multiple replicates, concentrations, representative soils, and controls to gauge the relative recovery performance of the accuracy and variability of each method.

Sterilization of sensitive drug delivery devices such as pre-filled syringes can be significantly enable by implementing Vaporized Hydrogen Peroxide VH2O2 (VHP) Low Temperature Sterilization for the process application. Utilizing VH2O2 has been widely used in biodecontamination of e.g., Pharmaceutical manufacturing spaces, isolators and lyophilizers for over 30 years, and terminal sterilization of sensitive combination products and other medical devices by VH2O2 also increasingly for the past 20 years. The 2022 published ISO 22441 for process validation, adoption by FDA and several other countries and FDA moving VH2O2 sterilization to Established Category A are strengthening its position. The near future EN 17180 for VH2O2 sterilizer equipment will provide specific guidance for implementing to pharmaceutical manufacturing process. Further, the work on VH2O2 specific biological indicator standard ISO 11138-6 and upcoming revision of the AAMI TIR 17 for guidance on material compatibility for sterilization modalities, will provide additional help and guidance.This presentation will provide guidance on all key elements of equipment and process validation of VH2O2 sterilizers and developed processes and recommendation on steps of application implementation, and also puts focus on key requirements of conformance and related materials and documentation, in the light of typical product applications sterilized by VH2O2.

With increased demand on sealed packed, pre-sterilized ready-to-use (RTU) components like Syringes & Vials, the ebeam technology is used as Annex 1 compliant transfer technology with surface sterilization for transfer of the RTU to higher grade A environment like Isolator

The digital transformation of pharmaceutical manufacturing brings about several opportunities and challenges in ensuring data integrity, one of the foundational elements of GxP compliance. As automated systems, advanced analytics, and interoperable digital tools become intrinsic parts of the operation, so too does the risk of vulnerabilities in data. This presentation covers the overall framework for mitigating these risks using a risk-based approach to data governance and integrity management.Key topics will include building resilient data governance frameworks, leveraging automation for proactive monitoring, and ensuring data traceability throughout the product lifecycle. Practical case studies will demonstrate how risk-based strategies enhance compliance, drive operational efficiency, and align with regulatory expectations such as FDA, EMA, and global GxP standards.This session bridges the gap between compliance and digital innovation, equipping attendees with actionable strategies to protect data integrity while optimizing manufacturing processes. Whether you are involved in quality assurance, regulatory affairs, or manufacturing science, this presentation will empower you to confidently navigate the complexities of the digital age.

Proposal DescriptionGene therapies hold tremendous potential, yet manual operations, product loss, and high costs impede patient access to vital treatments. The fill/finish processes are pivotal in optimizing drug product availability. Precision is paramount in formulating, filling, and packaging the therapies to preserve their efficacy and integrity. These challenges are leveraging advanced technologies like the adaptable Optima FillCell. This flexible and modular system streamlines operations, reducing reliance on manual labor and mitigating the risk of errors and contamination. Real-time monitoring and data analysis provide crucial insights, empowering manufacturers to optimize production parameters and minimize wastage, ultimately increasing the number of viable drug vials. By enhancing efficiency and maximizing overall yield.

The BIOSECURE Act, along with the recent election, stands to influence the reshoring of biomanufacturing activities in the United States, significantly impacting the growth of international technology transfers. However, these technology transfers are complex, requiring careful coordination across regulatory, quality, operations, and technical disciplines. When executed between international sites, these transfers become even more intricate due to varying regulatory requirements, compliance landscapes, and operational constraints. The resultant stress placed on people, processes, and technology results in an increased likelihood of misalignment, knowledge gaps, and inefficiencies that can negatively impact project timelines, budget, and ultimate product quality. In this poster, we will discuss a refined International Technology Transfer Playbook that we have developed to successfully approach technology transfer planning and execution. Included are strategies for comprehensive scope planning, successful knowledge and process transfer, risk management, validation, operational infrastructure, and training/proficiency requirements, which lay the groundwork for successful project delivery. Through practical examples, we will illustrate how this framework leads to successful outcomes for both companies and patients. Through deliberate planning and coordination, companies can accelerate commercialization timelines while maintaining product quality and compliance, extending their reach in global markets.

Ensuring the integrity of parenteral drug packaging is critical for maintaining product sterility and patient safety. This poster presents case study data on two applications of non-destructive, deterministic Container Closure Integrity Testing (CCIT) technologies: Vacuum Decay for IV bags and MicroCurrent (HVLDmc) for pre-filled syringes. The first study evaluates the effectiveness of Vacuum Decay Technology in detecting micro defects in 200mL and 300mL IV bags. A statistical footprint was established using thirty negative controls, followed by testing IV bags with defects ranging from 5μm to 20μm. Results confirm reliable detection of 20μm leaks in both sizes, with a demonstrated sensitivity down to 10μm at six standard deviations (LOD6SD) in 300mL bags. The study further validates the robustness of Vacuum Decay by showing consistent leak detection across various defect locations and sample orientations. The second study assesses the repeatability of the HVLDmc technology in detecting defects in pre-filled syringes over four weeks. Weekly testing confirmed consistent identification of negative controls, while all positive controls were detected in the first two weeks. In weeks three and four, two positive samples were not detected, possibly due to defect variability or clogging effects. These findings highlight the robustness of HVLDmc while emphasizing the need to understand defect characteristics and influencing factors. Key Takeaways: Gain a deeper Understanding the role of two technologies in parenteral packaging integrity testing. Effectiveness of Vacuum Decay for IV bags; Vacuum Decay Technology reliably detects leaks as small as 10μm in 300mL IV bags with a statistical confidence level (LOD6SD). Leak detection is consistent across various defect locations (bag body and ports) and sample orientations within the test chamber. Demonstrates non-destructive and deterministic testing for IV bag integrity.
Repeatability of HVLD MicroCurrent for Pre-Filled Syringes. HVLDmc provides a reliable method for leak detection in pre-filled syringes over a multi-week study. Practical Implications for Parenteral Drug Manufacturers. The importance of repeatability studies in CCIT to ensure robustness and reliability. Considerations for sample preparation and defect consistency when implementing these technologies reinforces compliance with regulatory expectations for deterministic, non-destructive integrity testing.

Autoinjectors facilitate self-administration of subcutaneous (SC) medications. Despite their benefits for patients and healthcare systems, experimental research on how they impact drug dispersion and absorption is limited. This study investigates how autoinjector injection parameters influence plume growth, morphology, and diffusion during and post injection.We investigated three commercial autoinjector models of a similar design with varying delivered volumes (0.5 mL, 1 mL, and 2 mL) injected into excised pork belly tissue. Synchrotron radiography provided high-resolution, real-time 2D visualization of plume dynamics during injection, while the 3D morphology of the depot post-injection was captured with a synchrotron CT. Our results show that plume growth is non-linear, with an initial rapid phase slowing over time. The final plume volume exceeds the delivered dose by 25%, reflecting depot spread within the tissue. Regardless of autoinjector model or injection volume, the plume predominantly expands horizontally (parallel to the tissue), with the aspect ratio increasing throughout the injection and reaching a final value of approximately 4. Post-injection diffusion appears to be driven more by tissue properties than by the autoinjector design parameters. These findings provide a foundation for refining autoinjector designs, developing more accurate computational models to predict drug absorption, and optimizing SC delivery systems.

Large-volume auto-injectors and wearable devices exceeding 2.25mL play a crucial role in the transition from hospital-based intravenous (IV) treatments to self-administrated drug delivery via subcutaneous (SC) injection.  These devices are especially pivotal in the treatment of oncological, immunologic, and neurodegenerative diseases, where they are often tasked with delivering high-viscosity and delicate biologics to patients in need. Ensuring the highest standards of quality and purity in elastomers, along with flawless functional performances, is imperative to guarantee the reliability of administration and patient safety. A balance of functionality, machinability, and product safety are essential for the entire device system to function.  In this presentation, we will delve into the technical hurdles encountered in designing and manufacturing larger coated plungers for pre-filled syringe (PFS) and cartridge containers intended for device integration. We will showcase our journey from conceptualization to commercialization of these coated plungers, as well as evaluating their performance throughout the entire value chain to the patient. Additionally, we will underscore the significance of fostering an open collaboration with the container manufacturer and among the additional stakeholders involved in the development of the final combination product.

Viral clearance by virus-retentive filters is a crucial step in many biomanufacturing process streams, including production of monoclonal antibodies and cell culture media.  Studies with model viruses or bacteriophage are needed to determine whether a specific filter should be categorized as a small or large virus retentive filter.  In this study, viral retention and flowrates were compared between Meissner’s 50 kDa and 500 kDa SepraPor® Hollow Fiber (HF) Ultrafiltration (UF) membranes used for Tangential Flow Filtration (TFF).  These filters were challenged with ~10 million plaque forming units (PFU) of the small bacteriophage ΦX174 suspended in deionized (DI) water.  It was determined that the 50 kDa SepraPor® HF UF membranes gave log-reduction values (LRVs) ≥ 5 with flowrates ranging from 15.9 to 46.7 mL/min at 15 psi constant pressure.  The 500 kDa SepraPor® HF UF membranes gave LRVs ≤ 0.74 with flowrates ranging from 8.8 to 286 mL/min.  These results show that Meissner’s 500 kDa SepraPor® filter membrane does not retain ΦX174 in water and does not function as a small virus retentive filter, while the 50 kDa SepraPor® filter membrane gives robust clearance of ΦX174 and can be categorized as a small virus retentive filter.