Mastering Particle Size Analysis: A Step-By-Step Illustration of Techniques and Best Practices

Understanding the measurement of particle size distribution is crucial when developing methods for quality control and when demonstrating bioequivalence for complex generic drug products. However, development, optimization, and validation of these methods can be challenging due, in part, to the apparent and deceptive simplicity of particle size analysis.

This two-day workshop will include discussions during the performance of hands-on, step-by-step procedures demonstrating how techniques can be performed in a manner that considers all relevant perspectives and enhances our collective understanding on the topic.

Attendees will gain theoretical and practical knowledge relevant to performing particle size measurements across diverse and challenging products like emulsions and suspensions. In-person attendees will interact directly with academic experts, instrument vendors, and regulators to delve into use cases, best practices, and limitations of particle sizing methodologies. Specifically, the workshop will focus on common particle sizing techniques such as dynamic light scattering and laser diffraction, common deficiencies and challenges encountered during quality assessments, bioequivalence studies, and manufacturing process evaluations.

Choose your experience:

Virtual Attendees will have free access to all sessions of the workshop except the hands-on activities and small group (in-person only) working sessions. Virtual attendees will be able to:

• Attend all presentations and panel discussions
• Participate in all Q&A panel discussions by submitting questions online in real time to the speakers and panelists
• Enjoy free access to workshop recordings of presentations and panel discussions (not including the in-person only sessions)

In-person Attendees will enjoy all of the benefits of virtual attendance as well as interactive experiences featuring:

• Hands-on activities with particle sizing systems from different manufacturers i.e., live particle size measurements of diverse and challenging products
• Small group working sessions during which challenging scenarios will be simulated and guided exercises will illustrate how to navigate decisions during particle size method development and study design for challenging drug products
• Collaborative discussion and learning opportunities with FDA, academic, and industry experts

Workshop Topics

• Theoretical/conceptual understanding of common particle sizing methodologies
• Regulatory perspectives on quality control and bioequivalence for complex generic drug products
• Live demonstration of data acquisition and analysis procedures using dynamic light scattering and laser diffraction systems
• Critical considerations for method development, validation, and reporting
• Expert guidance and illustration of best practices for overcoming challenges

Audience

The workshop is designed for individuals seeking to enhance their understanding of particle size analysis and its critical role in ensuring the quality and efficacy of generic drug products. This workshop is ideal for professionals working in the pharmaceutical industry, particularly those involved in the development, quality control, and regulatory affairs of generic drug products. This may encompass roles such as formulation scientists, analytical chemists, quality control specialists, regulatory affairs specialists, and research and development professionals.

• Virtual Attendance is optimal for an audience that would like to access workshop content from anywhere, eliminate travel time and expenses, and who would like to have the flexibility to attend dynamic sessions/presentations at preferred times.
• In-Person Attendance is optimal for an audience that is interested in collaborative discussions and real-time engagement, immersive learning, interactive sessions, and group activities.

Registration Fees:

• This workshop is FREE for virtual attendees.

• The combined cost for the two-day workshop in-person attendance and activities is:
  • $350, in-person attendees – general
  • $150, in-person attendees – government (must have an email ending in “.gov” in order to register at this rate)

For in-person attendees, beverages and food for breaks will be provided; lunch is not included. A link will be provided closer to the event for ordering lunch each day.

For faculty and students from the University of Maryland, Baltimore; The Universities at Shady Grove; and University of Michigan, the workshop is free for in-person attendance. Other students, please email us for a reduced rate. Please contact us at (info@complexgenerics.org) and indicate which workshop you are interested in.

Continuing education (CE) credits will not be provided for attending this workshop. A certificate of attendance will only be provided to individuals attending the workshop in-person.

Introduction to the Workshop

This 2-day hybrid workshop addresses challenges in particle size characterization for complex generic drug products. It aims to enhance understanding of Dynamic Light Scattering (DLS) and Laser Diffraction (LD) techniques, tackle method development and validation issues, and provide hands-on experience with equipment. By bringing together industry experts, regulatory scientists, and instrument vendors, the workshop fosters collaboration to overcome hurdles in generic drug development, identify research needs, and improve regulatory guidance. Participants will gain valuable insights through theoretical presentations, practical demonstrations, and interactive discussions.

DAY 1:

Session 1:  DLS Theory, Practice, and Regulatory Perspectives

Format: Presentations (Virtual and In-Person Attendees)

• This session provides a comprehensive overview of DLS technology, exploring its fundamental principles and practical applications in particle size analysis. Industry and regulatory scientists will delve into the current challenges associated with analyzing and assessing particle size studies, particularly in the context of characterization-based bioequivalence approaches. The session will also cover critical aspects of method validation and highlight common deficiencies observed in regulatory submissions, offering valuable insights for both researchers and industry professionals.

Session 2:  Vendor Perspectives for DLS

Format: Rapid fire presentations and a Panel Discussion with Q&A (Virtual and In-Person Attendees)

• In this dynamic session, seven DLS instrument vendors will present rapid-fire overviews of their latest technical developments and measurement best practices. These presentations will focus on innovative solutions to overcome common issues in particle sizing. Speakers will discuss critical considerations that guide users in selecting and operating DLS equipment effectively, providing real-world examples to illustrate the context of use. The session will conclude with an engaging panel discussion, allowing attendees to delve deeper into the topics covered throughout the morning.

Session 3:  DLS Equipment Demonstration

Format: Laboratory demonstration and discussion (In-Person Attendees Only)

• This hands-on session offers in-person attendees a unique opportunity to work directly with DLS equipment from seven manufacturers. Participants will be divided into small groups, rotating through demonstrations of suitable particle size study procedures. Vendor representatives will guide attendees through the intricacies of method development, highlighting common pitfalls and how to avoid them. This practical experience will provide invaluable insights into the nuances of different DLS systems and their applications in complex generic drug development.

Session 4: Small Group Working Session

Format: Small group working session (In-Person Attendees Only)

• In this collaborative session, attendees will work in small groups to tackle real-world challenges in particle size analysis. Guided by experienced moderators, participants will engage in in-depth discussions on multiple topics including measurement considerations, method development, method transfer, validation strategies, data analysis techniques and reporting.

DAY 2:

Session 5:  LD Theory, Practice

Format: Presentations (Virtual and In-Person Attendees)

• This session provides a comprehensive introduction to LD technology, exploring its theoretical foundations and practical applications in particle size analysis. Expert speakers will delve into the current challenges associated with LD-based particle size studies, offering insights into best practices and potential pitfalls. Attendees will gain a deeper understanding of LD principles, enabling them to make informed decisions when selecting and implementing this technology in their research or industrial settings.

Session 6:  Industry Perspectives on Particle Size Measurement

Format: Presentations (Virtual and In-Person Attendees)

• Industry experts will share their experiences and insights on the challenges faced in developing generic products, with a focus on particle size measurement. Speakers will discuss critical aspects such as technology selection, method development, and validation processes. The session will also explore the emerging role of artificial intelligence and machine learning in knowledge management for regulatory submissions. A key component of this session will be a discussion on potential hurdles in preparing submission packages and areas where additional FDA guidance could be beneficial.

Session 7:  Vendor Perspectives for LD

Format: Rapid fire presentations and a Panel Discussion with Q&A (Virtual and In-Person Attendees)

• This session mirrors the format of Session 2, focusing on LD technology. Four LD instrument vendors will deliver concise presentations highlighting their latest technical developments and measurement best practices. These talks will address common challenges in particle sizing and offer innovative solutions. Speakers will discuss critical factors that guide users in selecting and operating LD equipment effectively, providing practical examples to illustrate real-world applications. The session will conclude with a panel discussion, allowing attendees to engage with experts and explore the topics covered in greater depth.

Session 8:  LD Equipment Demonstration

Format: Laboratory demonstration and discussion (In-Person Attendees Only)

• Similar to Session 3, this hands-on session provides in-person attendees with the opportunity to work directly with LD equipment from four leading manufacturers. Participants will rotate through small group demonstrations, gaining practical experience with various LD systems. Vendor representatives will guide attendees through suitable particle size study procedures, highlighting the strengths and considerations of each system. This session aims to deepen participants’ understanding of LD technology and its application in complex generic drug development.

Session 9: Small Group Working Session

Format: Small group working session (In-Person Attendees Only)

• This session includes vendor-led discussions on pre-workshop sample measurements, including cyclosporine ophthalmic emulsions, phytonadione injections, iron sucrose injection, triamcinolone injectable suspensions, and microcrystalline cellulose. Vendors will share challenges encountered during these measurements and propose solutions. Participants will then engage in small group discussions, collaborating on particle size method development, validation, data analysis and reporting.

Session 10: Waypoint Exercise

Format: Small group working session (In-Person Attendees Only)

• The workshop will conclude with a comprehensive summary of key lessons learned and a forward-looking discussion on addressing identified challenges in the near future, setting the stage for continued progress in the field.