Optimizing Development, Manufacturing, and Technology Transfer in the Outsourced Relationship - Pharmaceutical Technology

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Optimizing Development, Manufacturing, and Technology Transfer in the Outsourced Relationship
The author analyzes a project for an injectable drug for which a new drug application was submitted to FDA as a case study of a multifaceted collaborative approach between a CMO and a sponsor.

Pharmaceutical Technology
pp. s38-s42

Planning the project
With the team in place, a schedule was determined for internal project follow-up and client communication. A crucial element was a project plan report to monitor progress on the milestones defined in a Gantt chart (a production control tool used in project management that provides a graphical illustration of a schedule to help plan, coordinate, and track specific tasks in a project). Another element was a global communications plan to review progress in the form of a twice-monthly meeting involving R&D, manufacturing, regulatory, quality, marketing, and project management teams.

In addition to this meeting, team meetings (between 2 and 4 each month) provided an update on the tasks being performed and helped identify any problems in the course of the project plan. Team meetings with the client (twice-weekly conference calls) were held to review the plan, make any adjustments, or introduce changes. In addition, management committees met as needed to make strategic decisions and evaluate changes that affected the initial planning.

These communication channels between the production areas (R&D, quality control, and manufacturing) and the client were vital to meet the tight schedule proposed by the client for launching the product in both the US and Europe, which involved a minimal time-to-market after FDA dossier approval.

Overcoming hurdles
Unexpected events can threaten to disrupt a schedule. At the initial stages of any project, particularly during the development phase, there is greater uncertainty in relation to how the latter stages will progress. The probability that problems will arise is also greater.

The first setback occurred during the analytical transfer due to the difficulty of the analytical methods. Grifols solved this by arranging for the customer to visit the facilities to make certain adjustments to the analytical methods in the high-performance liquid chromatography (HPLC) equipment.

Figure 1: A robotic palletizer deposits the product in autoclave trolleys. (All figures are courtesy of the author.)
Later, when Grifols had already defined the manufacturing process, chosen the material to produce the bags, manufactured the lots to include in the registration process, and started the stability studies, higher levels of impurities than expected were detected during the first accelerated stability studies. The incident was reported immediately to the client, and both teams set to work to provide a solution to the dilemma.

Materials for producing the bag that had originally been ruled out for other reasons were reconsidered and ultimately proved more compatible. At the same time, investigations led to the source of the impurities. As a result, the entire project was overhauled: new tasks were incorporated, new protocols were designed, and additional studies were performed. Grifols was given a month to reschedule the project and adjust the budget. Both teams worked in synergy, maintained a positive outlook, and collaborated by generously offering human and technical resources to keep the project afloat. No one lost any time looking for culprits or making accusations; everyone got on with the job of finding solutions in a race against the clock.


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