Case Studies in Pharmaceutical Project Management

A technical forum featuring Catalent Pharma Solutions, SAFC, and Neuland Laboratories.
Feb 01, 2012
Volume 2012 Supplement, Issue 1

Effective project management is an invaluable competency in a successful outsourcing relationship. Catalent Pharma Solutions, SAFC, and Neuland Laboratories, offer examples of successful project management, respectively in blow/fill/seal operations, viral-product manufacturing, and real-time project management in API manufacturing.

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Project management underpins successful relationships between contract technology and service providers and their sponsor companies. As pharmaceutical companies increase their level of outsourcing, it becomes increasingly important for contract technology and service providers to provide not only the technical capabilities needed to execute a given project, but the management skills to deliver a project on time, to specifications, and with the necessary communication to prevent or mitigate project delays. To illustrate the importance of project management in outsourcing, several industry members provided case studies on how to coordinate, organize, and implement a successful project. Participating in this technical forum on project management are Norman Weichbrodt, strategic account manager at Catalent Pharma Solutions; Nick Johnson, marketing manager at SAFC; and Saharsh Rao Davuluri, president of contract research at Neuland Laboratories.

Blow/fill/seal manufacturing

Norman Weichbrodt, strategic account manager at Catalent Pharma Solutions

Catalent Pharma Solutions is a provider of drug and biologic development services, delivery technologies, and supply solutions. Effective project management is the cornerstone of being a complete provider of services ranging from development of new products to technical transfer of existing products. Building the proper project team and employing the correct methodology for handling a complex project is the foundation on which success is achieved.

In July 2010, Catalent was approached by a major pharmaceutical customer to transfer an ophthalmic product approved for sale in Europe to Catalent's blow/fill/seal (BFS) manufacturing site in Woodstock, Illinois. The successful technical transfer of the manufacturing process for this product would potentially lead, following FDA approval of the product already made in the European facility, to approval of the drug for manufacture and sale in the United States.

Project scope. The actual scope of this project was much larger for the Woodstock facility than a simple technical transfer. The project required the following:

  • A complete renovation of a formulation and filling suite, including a new separate air-handling system
  • Designing, building, and qualifying an automated formulation skid
  • Upgrading an existing BFS filling machine to match the capacity requirements for the product
  • Designing, building, and qualifying new vial molding and filling systems to duplicate the existing European design
  • Qualifying the room, formulation skid, BFS machine, and secondary packaging to produce stability and process-validation batches to support the customer's submission and approval timeline
  • Developing and approving the required documentation for supply-chain, manufacturing, and quality assurance functions to meet the production timeline
  • Analytical-method transfer for chemistry and microbial testing
  • Complete process-validation protocols, test plans, and final reports to meet the submission timeline.

Cross-functional teams. To manage a project of this scope, the Catalent New Product Development (NPD) group and the site-management team agreed to form a group of cross-functional resources. The team members served as the primary representative of their functional area for the project and were assigned for the duration of the project. The project team consisted of a project manager from NPD, an engineering project manager, a development scientist, an operations specialist, a validation specialist, a quality-assurance product specialist, a technical writer, and various contract resources as required. A strategic account manager had overall responsibility for the project team. The establishment and use of an expanded core project team of cross-functional resources was a new approach for Catalent's Woodstock facility, but the scope and timeline for this project and the Catalent goal of meeting customer needs required an innovative solution.

The project was divided into six major activities: the room, the formulation skid, the BFS machine, method transfer, secondary packaging, and documentation. The NPD project manager was the owner of the overall project timeline. Each major activity was included in a Microsoft project schedule and maintained by the project manager. The engineering project manager handled all activities involving the renovation of the filling suite, making use of contractors from design through construction and qualification. He also participated in the design and construction of the formulation skid, primarily focusing on the software development. The development scientist and the operations specialist focused on the design of the formulation skid and the interface of the skid with the BFS machine to ensure the system had the proper design and controls to replicate the process already being used in Europe. The validation specialist developed the installatoin qualification, operational qualification), and product qualification protocols and had oversight of all factory acceptance testing (FAT) and site-acceptance (SAT) activities. The technical writer and the quality-assurance product specialist worked with the NPD project manager to manage the change-control process for the project and to complete all the required documentation, including material specifications, standard operating procedures, and manufacturing batch records. The NPD Project manager also provided oversight of the analytical method transfer, development of secondary packaging materials, and the documentation of project activities.

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