Developing a drug delivery system around the API Effective drug delivery development starts with understanding the molecule and its intended application. The target product profile defines requirements such as dose, administration route, release duration and relevant quality attributes. These requirements guide the selection of formulation technologies and the design of early feasibility studies. The objective is to identify a delivery approach that can accommodate the API while supporting the required product characteristics. Suitability must be established experimentally, since performance with one molecule does not automatically translate to another. For programs requiring sustained release following injection, long-acting injectable development introduces additional considerations related to the interaction between the API and its delivery matrix over time. Drug delivery challenges for peptides and biologics Peptides and biologics can present specific challenges because their molecular properties may make them sensitive to formulation and processing conditions. Depending on the API, temperature, solvent exposure, mechanical stress or changes in the local chemical environment may affect molecular integrity. These considerations become particularly relevant when an API is incorporated into a polymer matrix intended to regulate release over an extended period. The formulation environment may change as the matrix absorbs water, swells or degrades. Three questions are central to early development: Can the API be incorporated into the delivery system while retaining its relevant quality attributes? Can the formulation accommodate the required drug loading and target release profile? Can the selected approach be developed into a reproducible manufacturing process? Answering these questions requires a combination of formulation experiments, analytical characterization and an understanding of the selected delivery technology. SynBiosys® biodegradable polymer technology Innocore’s proprietary SynBiosys® platform is based on biodegradable multi-block copolymers containing hydrophilic and hydrophobic domains. The hydrophilic, PEG-containing domains absorb water and swell, while hydrophobic crystalline domains provide physical cross-links that contribute to the integrity of the polymer matrix. This polymer architecture allows formulation scientists to investigate the relationship between matrix composition, hydration, swelling, degradation and API release. These properties are relevant when developing sustained-release systems for peptides and biologics. SynBiosys® provides a technology platform for formulation development, rather than a universal solution for every molecule. The appropriate polymer composition, dosage form and processing conditions depend on the API and must be evaluated through molecule-specific studies. From delivery platform selection to formulation development Selecting a drug delivery technology requires balancing API compatibility with the intended product characteristics. Polymer composition, dosage form and manufacturing method all influence the options available to a development team. Microsphere-based formulations are one approach to sustained drug delivery. The API is incorporated into polymer particles, with release behavior influenced by factors such as drug distribution, matrix structure, water uptake and polymer degradation. During pharmaceutical formulation development, candidate formulations can be evaluated and refined against the target product profile. This may involve investigating polymer compositions, drug loading, processing conditions and the resulting release characteristics. The selection process is iterative. Analytical findings may identify a stability concern or release limitation that requires adjustment of the formulation or reconsideration of the delivery approach. Discuss your drug delivery development program Contact Innocore Analytical evaluation and manufacturing feasibility A drug delivery system must be characterized beyond its initial formulation composition. Relevant testing may include API content, molecular integrity, physical attributes and in vitro release behavior, depending on the dosage form and development stage. Analytical development provides methods to assess these characteristics and compare candidate formulations. For peptides and biologics, it may also be necessary to investigate whether the API retains its required molecular integrity during processing and release. Manufacturing requirements should be considered alongside formulation performance. Through process development, relevant processing parameters can be investigated for their influence on product attributes, reproducibility and potential scalability. Considering analytical and manufacturing requirements early helps establish whether a promising laboratory formulation provides a suitable basis for further development. An integrated approach to drug delivery development Drug delivery development benefits from close coordination between polymer science, formulation development, analytical characterization and process expertise. Decisions made during early feasibility work can affect subsequent formulation optimization and manufacturing requirements. Innocore brings these disciplines together to support pharmaceutical and biotechnology companies investigating polymer-based delivery systems for peptides and biologics. Development activities can be connected with broader CDMO services as programs progress toward subsequent manufacturing stages. This integrated approach supports informed development decisions based on the characteristics of the API, the target product profile and the experimental evidence generated throughout the program. Frequently asked questions about drug delivery development What is drug delivery development? + Drug delivery development involves designing and evaluating systems that deliver an API according to defined product requirements. It includes assessing API compatibility, formulation characteristics, release behavior and manufacturing considerations. How does drug delivery development differ from formulation development? + Drug delivery development focuses on selecting and developing the delivery approach, including the underlying technology and intended release behavior. Formulation development focuses on the composition and optimization of the specific dosage form. The activities are closely connected and often overlap. Why is polymer selection important for sustained-release drug delivery? + Polymer composition and structure can influence water uptake, swelling, API transport and degradation. These characteristics may affect the release behavior and formulation environment of a polymer-based delivery system. Can drug delivery systems be developed for peptides and biologics? + Peptides and biologics can be investigated for polymer-based drug delivery development. Their suitability depends on molecular stability, required dose, formulation compatibility and the intended product characteristics. Discuss your drug delivery development program Developing a suitable drug delivery system requires an understanding of the API, the intended product and the formulation technologies available. Innocore supports pharmaceutical and biotechnology companies with polymer expertise, formulation science and analytical development for sustained-release applications. Contact Innocore to discuss the technical requirements and potential drug delivery approaches for your molecule. Contact Innocore