Robert W. Lee, Ph.D., Senior Vice President of Business Development at Agno Pharma, will deliver a comprehensive presentation on November 20, 2025, addressing the formulation and process development strategies required to support GMP manufacture of sterile NanoCrystal suspensions. With over 34 years of pharmaceutical industry experience, Dr. Lee brings exceptional depth of knowledge to this technically complex topic that addresses one of the pharmaceutical industry’s most persistent challenges: formulating poorly water-soluble active pharmaceutical ingredients (APIs) for injectable delivery.​​

The presentation will explore NanoCrystal technology, an innovative drug delivery platform originally developed through collaboration between Sterling Winthrop Pharmaceuticals Research Division and Eastman Kodak. This groundbreaking technology leverages nanosized drug particles to dramatically increase surface area and dissolution rates, enabling the creation of sterile injectable formulations for APIs that would otherwise be unsuitable for parenteral administration. Dr. Lee was one of the founding members of NanoSystems, the pioneering drug delivery company focused on formulating water-insoluble drugs using high-energy media milling.​​

Addressing Critical Pharmaceutical Development Challenges

The fundamental problem Dr. Lee will address is the low aqueous solubility of many active pharmaceutical ingredients, which historically required the use of organic cosolvents, solubilizing agents, coarse suspensions, or pH extremes—all approaches that can introduce physiological incompatibility, toxicity concerns, or patient tolerability issues. NanoCrystal technology offers an elegant alternative by creating drug particles with radii in the nanometer range, dramatically increasing the relative surface area available for dissolution.​

This approach enables several critical advantages for parenteral drug products, including increased bioavailability through enhanced dissolution rates, the feasibility of sterile processing, enablement of intravenous injection for water-insoluble APIs, and the potential for long-acting injections via intramuscular and subcutaneous routes. The technology has proven particularly valuable for developing extended-release injectable formulations, where particle size can be carefully controlled to achieve desired pharmacokinetic profiles.​

Commercial Success and Clinical Applications

Dr. Lee’s presentation will showcase numerous commercially successful parenteral NanoCrystal suspension-based products that have achieved regulatory approval and market success. These include products for treating schizophrenia, pain management, inflammatory conditions, and contraception across multiple routes of administration including intramuscular, intravenous, intra-articular, and subcutaneous delivery. Notable examples include Invega Sustenna and Invega Trinza (paliperidone palmitate), which demonstrate how NanoCrystal technology enables once-monthly dosing of antipsychotic medications through controlled particle size design for extended release following intramuscular administration.​

The first GMP sterile NanoCrystal suspension, developed in 1995 using naproxen at a remarkably high concentration of 400 mg/mL, successfully demonstrated that these formulations could be manufactured aseptically and achieve critical clinical endpoints including absence of injection site irritation and pain on injection. This pioneering work established the foundation for subsequent commercial product development.​

Technical Expertise in Formulation and Manufacturing

The presentation will delve into the chemistry, manufacturing, and controls (CMC) considerations essential for successful NanoCrystal suspension development. Dr. Lee will address formulation development strategies, emphasizing the critical importance of understanding API solid-state characteristics and recognizing that formulation and manufacturing processes are inseparable components of successful end-product development. Key formulation components include stabilizers—which represent a fundamental difference from solution formulations—buffers, tonicity modifiers, antioxidants, antimicrobial preservatives, and cryoprotectants for lyophilized products.​

Manufacturing approaches utilizing high-energy media mills will be covered, highlighting the scalability of these systems and their suitability for commercial GMP production. Dr. Lee will discuss various sterilization strategies appropriate for NanoCrystal suspensions, including terminal sterilization via gamma radiation or heat, 0.2-micron filtration for ultra-small particles, and aseptic processing using sterilized ingredients and equipment. Notably, certain NanoCrystal suspensions can undergo terminal heat sterilization with minimal particle size growth, offering significant advantages for product stability and regulatory compliance.​

Pharmacokinetic and Pharmacodynamic Considerations

A significant portion of the presentation will address in vivo performance, pharmacokinetics, and pharmacodynamics of NanoCrystal formulations. For intravenous administration, Dr. Lee will discuss important considerations including the use of in-line filters and infusion rate optimization to minimize acute hemodynamic effects. The relationship between particle size and pharmacokinetic profile will be explored, particularly for intramuscular administration where larger particle sizes can extend duration of action by controlling the rate of dissolution and absorption from the muscle bed.​

Agno Pharma’s Leadership in Sterile Injectable Manufacturing

Dr. Lee’s presentation takes place in the context of Agno Pharma’s position as a world leader in sterile API and aseptic suspension manufacturing, including both coarse and nano suspensions. The company operates FDA-approved cGMP manufacturing facilities and has successfully passed six FDA inspections over a ten-year period. Agno Pharma’s Bethlehem, Pennsylvania facility features commercial aseptic fill lines, Grade A suites for sterile clinical supply, and specialized capabilities for handling high-potency compounds.​​

The company’s proprietary aseptic nanomill technology represents a significant advancement in sterile manufacturing capability, addressing the challenge that many nano and coarse suspensions are not amenable to terminal sterilization. This technology is scalable from development through commercial manufacturing, enabling seamless technology transfer as products advance through clinical development.​

Industry Recognition and Expertise

Dr. Lee’s career trajectory reflects deep expertise across all aspects of pharmaceutical development and manufacturing. He received his Ph.D. in Physical Bioorganic Chemistry from the University of California, Santa Barbara, and has held senior leadership positions at multiple pharmaceutical companies including Novavax, Lyotropic Therapeutics, IMCOR Pharmaceutical, Sterling Winthrop Pharmaceuticals, NanoSystems, and élan Drug Delivery. He has built de novo research and development organizations at multiple companies and maintains strong academic connections, including his appointment as Adjunct Associate Professor of Pharmaceutical Chemistry at the University of Kansas.​

His areas of expertise encompass preformulation, drug delivery, formulation development, analytical sciences, sterile manufacturing, and technology evaluation and development. This comprehensive technical knowledge combined with corporate management and business development experience positions Dr. Lee as an authoritative voice on the practical implementation of advanced drug delivery technologies in commercial pharmaceutical manufacturing.​

Advancing Patient-Centric Drug Delivery

Dr. Lee’s presentation on NanoCrystal suspension technology addresses a critical need in modern pharmaceutical development: creating patient-centric dosage forms that improve therapeutic outcomes while minimizing tolerability concerns. NanoCrystal suspensions offer the potential for pharmaceutically elegant formulations that are aqueous-based, isotonic, neutral pH, and contain minimal excipients, while achieving remarkably high API concentrations up to 500 mg/mL. For long-acting injectable applications via intramuscular or subcutaneous routes, larger particle sizes can be strategically employed to extend duration of action, reducing dosing frequency and improving patient adherence.​​

The November 20 presentation will provide pharmaceutical development professionals with comprehensive insights into the formulation strategies, manufacturing processes, sterilization approaches, and in vivo performance considerations essential for successfully developing sterile NanoCrystal suspension products. Dr. Lee’s extensive experience founding and leading development organizations, combined with his deep technical expertise in this specialized area of drug delivery, makes this presentation an invaluable resource for scientists and business leaders working to advance poorly soluble compounds through development and into commercial manufacturing.​​

To download the presentation here 2025 1120 APV Presentation Robert W. Lee.