2026 CRBE Summit East - Innovations in Controlled Release, Bioavailability Enhan

The pharmaceutical industry is undergoing a profound transformation, shifting from traditional batch processes to continuous manufacturing. This evolution is partly propelled by advances in Process Analytical Technology (PAT) and the foundational principles of Quality by Design (QbD). Transitioning to a SMART factory mode of operation, however, requires technological innovation, significant professional development, and the maturity of regulatory and management systems. The issue of data integrity breaches (BAD-I), with its historical implications and current prevalence, serves as a critical backdrop for understanding how to balance technological progress with the necessary professional and systemic maturity. This balance is essential to ensure the successful guidance of pharmaceutical manufacturing through this revolutionary phase. In this presentation, we will introduce a SMART framework designed to provide a common-sense foundation for navigating the complexities of pharmaceutical manufacturing’s evolution. This framework will offer ways to ensure that data integrity, technological advancements, and professional maturity move in concert toward a more efficient and compliant future.

Eudracap® capsules leverage functional polymer technology to deliver enteric and site-specific release without additional coating steps. These systems enable robust performance, reduced process complexity, and improved scalability. This session will examine formulation considerations, performance data, and applications across modified release strategies.

Room-Temperature Aerosol Dehydration (RTAD) is an emerging continuous drug product formulation platform that converts liquid biologics and vaccines into shelf-stable, bioactive powders without cold chain dependency. Developed at Princeton University and commercialized by Inaedis, Inc., this scalable cGMP-compatible process gently generates aerosols of sub-20 µm droplets that flash-evaporate at room-temperature conditions — preserving biomaterial potency while eliminating the harmful thermophysical and dehydration stresses inherent to
conventional spray drying and lyophilization.
From a formulation standpoint, RTAD uniquely bridges enabling thermal stability, controlled release and bioavailability enhancement for biologics. Technology allows precise control over particle morphology, size distribution, and excipient composition to tune drug release profiles and improve the bioavailability of high-molecular-weight therapeutics across multiple delivery routes. RTAD supports diverse therapeutic platforms including proteins, monoclonal antibodies, viral vectors, mRNA-lipid nanoparticles, live-attenuated vaccines, bacteriophages, and subunit formulations. Additionally, RTAD enables ultra-concentrated formulations of biologics, e.g., mAbs with >400 mg/mL, compatible with prefilled syringes and autoinjectors — reducing dose volumes and facilitating multi-antigen delivery with favorable pharmacokinetic profiles.
RTAD-produced thermostable powders accommodate versatile delivery systems aligned with the controlled release landscape: subcutaneous administration, inhalation via dry powder inhalers and nebulizers, transdermal administration, and. The continuous, scalable nature of the
aerosol dehydration process offers a promising alternative to batch lyophilization, opening new pathways for continuous biopharmaceutical manufacturing of thermostable solid-dose biologics.
This formulation platform addresses critical stability and manufacturability challenges across oncology, autoimmune diseases, gene therapy, and vaccination, while expanding therapeutic access through flexible, cold-chain-free delivery strategies that improve patient compliance and
enabling equitable global distribution of next-generation biologic therapies.

Lipid-based emulsions are increasingly used to enhance drug delivery, yet the impact of lipid digestion on permeation outcomes is often overlooked. This session examines how enzymatic digestion transforms emulsions into dynamic colloidal structures—such as mixed micelles and vesicles—that directly influence drug solubilization and transport across biological barriers. We will discuss why conventional in-vitro permeation models, when applied without accounting for digestion processes, may fail to predict in-vivo performance. Key factors including lipid composition, droplet size, bile interactions, and digestion kinetics will be highlighted. Attendees will gain practical insight into designing more biorelevant in-vitro permeation models that better reflect physiological conditions and support informed formulation development.

Nasal drug delivery is emerging as a powerful alternative for small molecules limited by poor bioavailability. This session explores the design of a universal nasal delivery platform engineered to overcome solubility, permeability, and stability challenges. Discover how smart formulation and device strategies can unlock rapid absorption, consistent exposure, and new therapeutic potential for molecules once considered undeliverable.

This session explores practical strategies for ASD development and manufacturing across a spectrum of molecule complexity, from straightforward to highly challenging. Formulation, scale-up, and manufacturing approaches will be discussed with case studies for a range of selected compounds. A case study including development of an extended release tablet for an ASD intermediate will be presented.

Long acting injectables offer a powerful approach to improve patient care and reduce global healthcare costs through reduced dose frequency and better medication adherence.  However, LAI product design requires a deep understanding of chemistry, manufacturing, and controls (CMC) aspects, including material properties, formulation, processing, and device characteristics. This session will review various formulation strategies that have been successfully applied to commercial LAI products and selection of an appropriate formulation technology guided by drug properties and the desired product profile.

Attendees will gain insights into the value proposition for LAIs in the pharmaceutical industry, different types of LAI dosage forms, and the technical challenges impacting formulation development and manufacture.

Excipient safety has become a growing focus for regulators, industry, and the public, particularly around topics such as nitrosamines, talc, titanium dioxide, and pharmaceutical colorants. This session will review the current scientific evidence and regulatory perspectives surrounding these widely discussed materials. By separating data-driven risk assessments from common misconceptions, the presentation will provide a clear overview of how excipient safety is evaluated and communicated in today’s evolving regulatory and public landscape.

PBBM and PBPK modeling are increasingly central to mechanistic understanding of drug absorption and systemic exposure. By linking critical material attributes, process parameters, and physiological variables, these approaches enable quantitative prediction of in vivo performance, virtual bioequivalence, and biowaiver strategies. This session will highlight recent advances in model-informed drug development (MIDD), including applications in complex formulations, nonlinear absorption, and regulatory decision-making.

Lipid nanoparticles (LNPs) have emerged as a transformative platform for drug delivery, yet optimizing their design remains complex. This session will explore how formulation strategies, lipid selection, and process parameters can be fine-tuned to improve stability, targeting, and delivery efficiency. Attendees will gain practical insights into overcoming key development challenges and unlocking the full potential of LNPs across a growing range of therapeutic applications.

Overcoming the Challenge of Processing Permeation Enhancers into Robust Drug Product.