Specialized CDMO services for complex injectable formulations Innocore’s CDMO approach is centered on the technical requirements of the molecule and its target product profile. Rather than treating formulation development and manufacturing as separate activities, relevant process and analytical considerations are incorporated as the formulation progresses. Innocore’s specialization in peptides, biologics and biodegradable polymer systems provides a focused development environment for investigating these requirements. For programs involving sustained API release, long-acting injectable development requires particular attention to polymer behavior, molecular integrity, drug loading and release reproducibility. These characteristics influence both the selection of a delivery approach and the manufacturing strategy. CDMO capabilities across the development process Different stages of pharmaceutical development require different technical capabilities. Innocore combines complementary services to support the progression of a candidate formulation while maintaining continuity of formulation and process knowledge. Service Development focus Drug delivery development Evaluating delivery technologies and polymer systems against API properties and target product requirements. Pharmaceutical formulation development Investigating formulation composition, API compatibility, drug loading, stability and release behavior. Analytical development Developing methods to characterize the API, dosage form and relevant quality attributes. Process development Investigating manufacturing parameters, process reproducibility and scalability. Technology transfer Transferring formulation, analytical and process knowledge between development and manufacturing activities. GLP and GMP manufacturing Supporting manufacturing activities appropriate to the program’s development stage and applicable quality requirements. The scope of each program depends on the API, dosage form, development objectives and required manufacturing activities. Individual services can be considered within a broader development strategy. Polymer-based drug delivery expertise 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 contribute physical cross-links and structural integrity. These polymer characteristics are relevant when investigating sustained-release formulations for peptides and biologics. The relationship between polymer composition, API properties and release behavior must be evaluated for each formulation. Through drug delivery development and pharmaceutical formulation development, Innocore investigates how the selected polymer system and formulation parameters can be aligned with the intended product characteristics. The technology platform provides a foundation for development, but molecule-specific studies remain necessary to establish compatibility and technical feasibility. Connecting analytical and process development Analytical evidence is essential when comparing candidate formulations and understanding the effects of development changes. Depending on the API and dosage form, relevant characteristics may include molecular integrity, drug content, physical attributes and in vitro release behavior. Through analytical development, suitable methods can be established to evaluate these characteristics and support formulation decisions. At the same time, process development investigates how manufacturing conditions influence critical product attributes. Parameters affecting particle formation, mixing, material handling or other dosage-form-specific operations may become important as a formulation progresses. Considering analytical and process requirements together helps development teams evaluate whether promising formulation results can be reproduced and developed further. Discuss your CDMO development requirements Contact Innocore Technology transfer and manufacturing support Progressing from development experiments toward manufacturing requires the transfer of technical knowledge, not simply a formulation recipe. Relevant information may include material specifications, processing parameters, analytical methods, product attributes and documented development findings. Technology transfer supports the continuity of this information as manufacturing activities change in scale, equipment or quality requirements. Depending on the program and its development stage, Innocore’s manufacturing services may include GLP manufacturing and GMP manufacturing. The appropriate manufacturing approach and applicable quality framework must be established for the intended use of the material. Integrating manufacturing considerations into earlier development activities helps identify potential limitations before a program advances to its next stage. Working with Innocore as a CDMO partner CDMO collaboration begins with understanding the molecule, the development stage and the technical questions that need to be answered. A program may require an initial feasibility assessment, optimization of an existing formulation or support in preparing a process for subsequent manufacturing. Innocore’s integrated capabilities allow formulation, analytical and process considerations to be evaluated within a coordinated development approach. The scope of work is defined around the requirements and uncertainties of the individual program. For pharmaceutical and biotechnology companies developing sustained-release formulations, this provides a way to connect early formulation decisions with the technical requirements of later development and manufacturing activities. Frequently asked questions about CDMO services What does a pharmaceutical CDMO do? + A contract development and manufacturing organization provides development and manufacturing services to pharmaceutical and biotechnology companies. The scope may include formulation development, analytical testing, process development, technology transfer and manufacturing, depending on the provider’s capabilities and the program’s requirements. What types of development programs does Innocore support? + Innocore specializes in polymer-based sustained-release drug delivery, particularly for peptides and biologics. The technical scope of a project depends on the API, dosage form and intended development stage. Can a CDMO support a project before a final formulation has been selected? + Yes. Early development activities may include API characterization, feasibility assessment and formulation screening to determine which approaches warrant further investigation. Why is an integrated CDMO approach relevant for long-acting injectables? + Long-acting injectable performance depends on interactions between the API, delivery matrix, formulation parameters and manufacturing process. Coordinating these disciplines helps development teams evaluate changes against the complete product requirements. Discuss your CDMO development requirements Innocore supports pharmaceutical and biotechnology companies developing complex sustained-release formulations for peptides and biologics. Its polymer technology, formulation expertise and analytical, process and manufacturing capabilities can be combined according to the requirements of the development program. Contact Innocore to discuss your API, development objectives and the CDMO services relevant to your project. Contact Innocore