Integrated Product Development
Time- and cost-effective product development and registration demand that CMC activities keep pace with the stage of development and that the risks are identified and mitigated. The characterization of new chemical entities, design of robust manufacturing processes, establishment of adequate controls and specifications, and management of the drug substance and drug product supply chains, from clinical development through commercialization, must be in sync with the stage of development, sponsor goals, and applicable laws and regulations. We provide development strategies that drive the overall product development process to meet milestones in a cost-effective manner and resources to oversee and execute activities.
Vendor Identification & Management
Selecting and efficiently managing vendors that are reliable as well as technically competent is one of the best tools available for minimizing the time necessary to develop and register a healthcare product. We support sponsors by providing recommendations, drafting detailed requests for proposals for accurate service bid obtainment, evaluating bids, and assisting in the determination of placing contracts. Contract manufacturers, laboratories, and suppliers require diligent oversight and management to prevent development delays and cost overruns and to ensure the quality of products and deliverables. We can act as the sponsor’s CMC team overseeing CMC development at contract manufacturing organizations to ensure timely project advancement.
Materials Characterization & Formulation Development
SciLucent guides sponsors in the critical exercise of materials characterization and the establishment of reference standards for new chemical entities as well as in the formulation of drug products from the IND-enabling stages of development through postapproval evergreening changes. We have experience with small molecule and biotechnology products and the full range of dosage forms and routes of administration.
Process Development, Optimization, Scale-up & Validation Oversight
Appropriately staged process development activities ensure the quality of the materials being produced and the reliability of the clinical supply chain as it moves from bench-top through scale-up to commercialization. We have experience with small molecule and biotechnology drug substance processes and the manufacturing of various drug product dosage forms. We provide guidance on process characterization and optimization studies, the management of scale-up and process changes, and the execution of process validation, all in order to demonstrate that manufacturing is well controlled and robust.
Establishment of Manufacturing Controls
Establishing adequate, stage-appropriate manufacturing controls is a delicate balance in cost-effective product development. Compliant manufacturing and obtaining adequate data are critical to support nonclinical and clinical activities. We assist in the development and justification of control strategies based on the specific therapeutic class, current regulatory expectations, and risks. This includes controls associated with small molecule starting materials, cell banks, potential genotoxic impurities, and the specific drug product dosage form.
Analytical Method Development, Optimization & Validation
SciLucent can oversee the development of appropriate analytical methodologies at contract vendors for use in the characterization and control of starting materials, drug substances, intermediates, and drug products. This covers the full lifecycle of analytical methodology including creation, optimization, transfer, and qualification/validation.
Supply Chain Management
Healthcare product manufacturers need capable oversight and development of clinical and commercial supply chain to ensure a continued supply of goods to the clinic and the market. We provide logistical oversight from the acquisition of raw material at the beginning of the process through to kitting and delivery of clinical materials to trial sites for developmental programs and 3PL warehousing for commercial products.
CMC Regulatory Affairs Support
As an investigational product moves closer to commercialization and final to market, the CMC information is collected, maintained, and updated for both the drug substance and drug product. We prepare CMC meeting requests and packages, quality sections of U.S. and ex-U.S. regulatory submissions, CMC information amendments and supplements, DMFs, and IMPDs.
with Manufacturing & Development experience include: