AAPS PharmSci360 2025

AAPS PharmSci360 2025

 

Monday itinerary Tuesday itinerary Wednesday itinerary 

Henry B. Gonzalez Convention Center  
San Antonio, TX 

Stop by Booth 2931 and strengthen your compendial strategy with USP 

Visit our booth to discover how proactive engagement with USP can enhance your regulatory strategy and support global market success. Learn when and why to collaborate on standards development, how involvement in the process can reduce compliance risks by aligning your current regulatory requirements to future compendial requirements. Quality medicines benefit everyone: your organization gains competitive advantage while patients receive safe and effective treatments. 

Don’t miss this opportunity to connect with USP experts and take a strategic step toward shaping the future of quality standards. Stop by and speak with USP experts— equip yourself today for more confident submissions tomorrow. 

View the full agenda: https://aaps2025.eventscribe.net/index.asp

USP participation 

Monday, November 10 

12:00 PM – 1:00 PM  
New Horizons in SFC and AQbD: Faster, Greener Solutions from Development to Delivery  
Location: 360 Stage #1, Exhibit Hall  
Paolo Lecchi, Ph.D., USP  
Brian Domanski, Shimadzu Scientific Instruments, Inc.  
Niray Bhakta, MS, The University of Texas at Arlington 

Drug development and analysis across modalities relies on separation technologies, from synthesis and purification to ADME/DMPK to final QA/QC. While SFC has long played a role in Pharma and Biopharma, the versatility, ease of use, and complementarity of tools for the technique are experiencing a renaissance. SFC can reduce or eliminate use of hazardous solvents, creating sustainable, efficient separations that minimize potential harm to users and the environment. In this session, we examine SFC as alternative for normal phase monographs, AQbD method development tools to optimize separations of peptide therapeutics, and other emerging uses of SFE-SFC and SFC-MS. Join us for a discussion of how SFC can provide faster, greener, and better separations for therapeutics from development to delivery. 

Learning Objectives: 

  • Understand how SFC can be used in Pharma and Biopharma for diverse roles in applications supporting development to quality analysis.
  • Define the advantages of SFC and SFE with respect to environmental impact, separation efficiency, and alternate selectivity.
  • Discuss how AQbD method development and robustness testing tools for SFC allow easy integration alongside traditional HPLC workflows. 

2:30 PM – 3:30 PM  
M1430-02-13 Diethylene Glycol and Ethylene Glycol Challenges: Compendial Approach and Emerging Standards  
Manufacturing and Analytical Characterization - Chemical Poster Session  
Tong (Jenny) Liu, Ph.D., USP  
Catherine Sheehan, DRSc, MS, MS, USP 

Purpose: Since 1937, poisoning cases caused by contaminated or adulterated diethylene glycol (DEG) and ethylene glycol (EG) in medicines have been reported worldwide. See Table 1. (1-11) In response, the US Food and Drug Administration (FDA) and USP have been collaborating to address these serious public health issues. From 2007 to 2013, USP updated seven high-risk excipients, including Glycerin, Propylene Glycol, three Sorbitol solutions, Maltitol Solution and Hydrogenated Starch Hydrolysate, by adding the EG/DEG test to the Identification (ID) section of these monographs, consistent with the requests from the FDA. Additionally, a general chapter < 469 > ETHYLENE GLYCOL, DIETHYLENE GLYCOL, AND TRIETHYLENE GLYCOL IN ETHOXYLATED SUBSTANCES was developed in 2013-2014. >Tragically, between 2022 and 2023, over 300 fatalities—primarily children—occurred again in several countries due to EG/DEG contamination or adulteration of these high-risk excipients. Therefore, the World Health Organization (WHO) issued several alerts (1, 4–11), and the US FDA released a guidance in May 2023 for immediate implementation of industry to test high-risk excipients for EG and DEG (12). USP is currently employing multiple approaches, including both compendial and iterative approaches – emerging standards, to address the FDA’s February 2023 letter concerning the revision of the Polyethylene Glycol (PEG) monograph (13) and another FDA request to publish a validated EG/DEG testing method for liquid oral dosage forms. This poster will detail the proposed methods outlined in Chapter < 470 > Determination of Ethylene Glycol, Diethylene Glycol, and Triethylene Glycol in Polyethylene Glycol and the EG/DEG testing methods for dosage forms that are intended to be published as emerging standards. Representative chromatograms will also be included to illustrate the methods. 

Methods: In response to the FDA’s 2023 letter regarding PEG, USP issued several General Announcements and conducted a stakeholder survey between 2023 and 2024. These efforts aimed to gather feedback, collect batch data across various PEG grades, and obtain available EG/DEG testing methods from industry. As a result, the PEG monograph revision proposal was published in PF 50(3) [May – Jun. 2024] to include the EG/DEG test in the ID section with appropriate specification limits. (14) Since the existing EG/DEG testing method in Chapter < 469 > is not ideal for frequent ID testing because of high column temperature and long run time, a new standalone general chapter < 470 > was developed, as part of an iterative approach.(15) The new chapter < 470 > was published in PF 50(5) [Sep.-Oct. 2024] to propose several EG/DEG testing procedures for stakeholders to evaluate the equivalency and interchangeability of these methods and use them as alternative methods as necessary. USP also published an EG/DEG toolkit that is free for all interested stakeholders (16). In addition to testing high-risk excipients for EG and DEG, the US FDA laboratory has developed and validated a gas chromatography–mass spectrometry (GC-MS) method for detecting EG/DEG in liquid cough, cold, and allergy products containing glycerin. In collaboration with the FDA, USP plans to publish this method as an emerging standard. USP recently received several additional EG/DEG testing methods for oral drug dosage forms, including GC with flame ionization detection (GC-FID), GC-MS, and high-performance thin-layer chromatography (HPTLC). USP also plans to publish these methods using the emerging standards approach. 

Results: Five EG/DEG testing procedures for PEG have been proposed in the new Chapter < 470 >. The highlights of these methods have been summarized in Table 2. As shown in Table 2, different column temperature and run time of each method affect the column lifetime and its suitability for frequent ID testing. Additionally, each method is only suitable for a certain range of PEG molecular weight. Four EG/DEG testing methods for oral liquid dosage forms are summarized in Table 3 and will be published as emerging standards on the USP website. To showcase the above methods, representative chromatograms will be displayed on the poster. 

Conclusion: USP is taking multiple approaches to support stakeholders in addressing the significant public health risks posed by EG/DEG contamination/adulteration. By leveraging compendial standards and emerging standards, USP offers tools that enable stakeholders to implement effective quality control testing of EG/DEG for high-risk excipients and drug dosage forms. The approaches include: Compendial standards: 1) Update the high-risk excipient monographs by adding the EG/DEG test to the ID section that stakeholders must implement to comply with the current Good Manufacturing Practice (cGMP) requirements according to US Food, Drug & Cosmetics Act. 2) Create a standalone chapter < 470 > to provide analytical methodologies for stakeholders to evaluate and select based on their intended use. The methods are not mandatory if the chapter is not cross-referenced in monographs. Emerging Standards: Publish methodologies for EG/DEG testing in drug dosage forms through an emerging standards approach. While not mandatory, these emerging standards serve as early-stage tools to engage stakeholders and explore potential pathways toward the development of official compendial standards. 

References: 

Read more

Acknowledgements: This poster was based on the work of the USP 2020-2025 Complex Excipients Expert Committee. The views expressed in this poster are those of the authors and do not reflect official views and policies of the USP, USP Council of Experts, or the authors' institutions. Tuesday, November 11, 2025 Mentor Breakfast USP Sponsor 

Tuesday, November 11, 2025 

Mentor Breakfast USP Sponsor 
Tuesday, November 11, 2025 
7:00 AM - 8:30 AM   
Location: Stars at Night Prefunction 

As gene therapy advances toward broader clinical applications, the need for robust quality standards and harmonized regulatory frameworks has become paramount. This session will explore the quality assessment of gene therapy, specifically the standardization of analytical methods for adeno-associated virus (AAV) vectors. For AAV-based therapies, the session will delve into analytical standardization challenges for raw materials, titer determination, empty-full analysis and process impurities. It will highlight efforts to reduce variability across laboratories and ensure data comparability, supporting the development of consensus-based standards for vector identity, purity, and potency.

In this symposium, attendees will hear perspectives about shaping quality expectations and analytical methodologies, including how standardized, fit-for-purpose testing approaches can be integrated into existing workflows and how to navigate the interface between innovation and regulatory compliance. There is a lack of harmonized analytical standards for AAV products, leading to inconsistent quality data and regulatory uncertainty. This session addresses the implementation of standardized approaches in line with regulatory expectations.
Learning Objectives:

  • Understand best practice AAV product analytical control strategies.
  • Compare analytical methods for AAV characterization to select appropriate techniques.
  • Discuss standards that support the development and implementation of effective quality assessment protocol
     

10:30 AM – 11:00 AM  
Location: 221 AB  
Advancing AAV Standards in Gene Therapy  
Ben Clarke, PhD, USP 

As gene therapy advances toward broader clinical applications, the need for robust quality standards and harmonized regulatory frameworks has become paramount. This session will explore the quality assessment of gene therapy specifically the standardization of analytical methods for adeno-associated virus (AAV) vectors. For AAV-based therapies, the session will delve into analytical standardization challenges, particularly capsid characterization and genome titration. It will highlight efforts to reduce variability across laboratories and ensure data comparability, supporting the development of consensus-based standards for vector identity, purity, and potency. Through an expert panel discussion, attendees will hear perspectives from scientists, regulators, and industry professionals actively shaping quality expectations and analytical methodologies. The panel will explore how standardized, fit-for-purpose testing approaches can be integrated into existing workflows and how to navigate the interface between innovation and regulatory compliance. 

This session aims to bridge the gap between high-level regulatory guidance and practical laboratory implementation, empowering participants with actionable insights to strengthen their quality systems in alignment with the evolving gene therapy landscape. 

There is a lack of harmonized analytical standards for AAV products, leading to inconsistent quality data and regulatory uncertainty. This session addresses the implementation of standardized approaches in line with regulatory expectations 

Learning Objectives: 

  • Analyze critical quality attributes and regulatory guidance for AAV products to assess compliance strategies.
  • Compare analytical methods for AAV characterization to select appropriate techniques across development phases.
  • Identify components of effective quality assessment protocols that meet current regulatory expectations for gene therapy products. 

Wednesday, November 12  

11:30 PM – 12:30 PM  
W1130-02-12 Sustainable Separation: Supercritical Fluid Chromatography as a Modern Replacement for Normal Phase Chromatography  
Manufacturing and Analytical Characterization - Chemical Poster Session  
Paolo Lecchi, Ph.D., USP 

12:00 PM – 1:00 PM  
Science Meets Strategy: Building Business Development Careers from Research Roots  
Location: Careers 360, Exhibit Hall  
Career Center Moderator: Allison Elizabeth Radwick, PhD, USP 
Career Center Speaker: Joe Flynn, BS, COMMEX Consulting  
Career Center Speaker: Ami Patel, MS, BOYDS 

This session examines the strategic career transition pathway from research science to business development and sales roles within contract research organizations (CROs), contract development and manufacturing organizations (CDMOs), and laboratory products/instruments companies. As the life sciences industry continues to expand, these organizations increasingly value professionals who combine deep scientific knowledge with commercial acumen, creating unique opportunities for scientists seeking career evolution beyond the laboratory. 

The session will explore the distinctive value proposition that research scientists bring to business development positions, including their ability to engage in high-level technical conversations, quickly grasp client challenges, and translate complex scientific needs into appropriate solutions. We will examine how scientific expertise enhances credibility with clients, enables effective qualification of opportunities, and facilitates the building of trusted advisory relationships rather than transactional sales interactions. 

Participants will gain insights into the specific skills and competencies required for success in business development roles, including those that may already exist within their scientific toolkit and those that require deliberate development. The presentation will address common transition challenges, from adopting commercial mindsets to building business acumen, and provide practical strategies for addressing these gaps. We will explore various entry points into business development careers, from application scientist and technical support roles to account management and specialized sales positions. We will illustrate diverse career progression paths taken by scientists who have successfully made this transition. 

By bringing together insights from both successful career transitioners and hiring managers, this presentation aims to equip research scientists with actionable strategies for pivoting their careers toward the dynamic intersection of science and business. 

Learning Objectives: 

  • Analyze how specific scientific expertise and research experience create distinctive value in business development roles across CROs, CDMOs, and instrument companies.
  • Evaluate personal strengths, skill gaps, and preferences to identify optimal business development roles and organizational environments aligned with individual backgrounds.
  • Transform research accomplishments and technical expertise into compelling narratives that demonstrate commercial potential to hiring managers and potential employers.