Inhalation

catalent.com standard terms and conditions will require agreement and, in some cases, negotiation between the two parties. With outsourced projects where production of clinical sup- plies is involved, additional documents such as Clinical Supplies and/or Quality Agree- ments may be required. For work involving cGMP studies or production of clinical sup- plies, it is also advisable, where possible, to per-form a Quality Assurance (QA) audit of the facility being evaluated to ensure that there are no regulatory concerns about plac- ing work with the selected CRO. Once the quote is signed and all other nec- essary legal agreements in place, the CRO will assemble a project team and outline the key program objectives, deliverables, and milestones. They will then establish a pro- ject timeline in preparation for project initi- ation. Following a kick-off meeting with the customer to finalize agreements on the pro- gram objectives and project timelines, the actual laboratory work can begin. In plan- ning for success, it is key that both parties agree upon an effective development pro- cess that encourages teamwork and a coor- dinated cross-functional development path for the program, while providing a forum for addressing and correcting any issues within the program as early in the development cy- cle as possible. The objective of a well-designed product develop-ment process is to facilitate good business decisions and timely management oversight throughout the program lifecycle; to provide the customer with assurance that required tasks, deliverables, and documen- tation will be completed prior to program maturity; and to provide an essential gating mechanism such that program budgets and resource allocation needs can be examined in a timely manner. By relating functional responsibilities to key program activities, horizontal integration of vertically organized functions is encouraged, resulting in a uni- fied team approach to development. The authors would like to thank Robin Spiv- ey and David Wilcox, Senior Scientists in Re- search & Development; Sterile, Respiratory & Analytical Services. Craig Davies-Cutting is Director of Research and Development at Catalent Pharma Solutions, P.O. Box 13341, Research Triangle Park, NC 27709. Tel: +1 919 465-8430. Craig.Davies-Cutting@ catalent.com. Dean McKinney is Director, Busi- ness Development at Catalent. Tel: +1 919 465- 8215. Dean.McKinney@catalent.com. Stages of a typical product development project Feasibility Determine feasibility of developing formulation in the requested dosage form(s). Objectives: • Evaluate/screen formulation options • Establish analytical methods • Provide materials for early pre-clinical studies (if requested) Product Proof of Concept Establish product concept for pre-clinical and early clinical studies (Phase I and Phase IIa). Objectives: • Evaluate formulation compatibility with primary packaging options • Qualify analytical methods for Phase IIa clinical studies and establish cleaning verification method(s) • Provide materials for pre-clinical, Phase I and Phase IIa studies (as required) Product Optimization Product optimization—all product strengths (API, formulation, packaging) for Clinical Phase IIb studies Objectives: • Refine formulation and primary packaging and/or device to achieve product development targets • Additional analytical methods qualification for Phase IIb clinical studies (if required) • Provide materials for Phase IIb studies (as required) • Verify timing of Phase III readiness Process Scale-up Commercial-scale process defined for Clinical Phase III/registra- tion batch production Objectives: • Validate analytical methods with final product(s) • Optimize production process • Scale-up manufacturing process to not less than 1/3 commercial batch size • Validate cleaning methods for process equipment • Provide materials for Clinical Phase III/registration studies Product Registration Studies Generate supporting data and write product dossier Objectives: • Conduct Registration stability studies • Conduct Developmental Pharmaceutics studies • Prepare Registration Dossier including stability package • Validate Full-Scale Manufacturing Process-if required for EU • Complete validation of cleaning methods for process equipment • Provide materials for registration stability Commercialization Preparation for product launch Objectives: • Respond to regulatory deficiency questions and support PAI • Process validation/Produce commercial launch supplies 19

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