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

Figure 2: An overwrapping system is used for double bagging the product.
Modifying manufacturing
On the production side, two factories located 600 km (more than 370 miles) apart needed to be coordinated. The production lines at both factories, in Parets del Vallès (Barcelona) and Murcia, were modified to meet customer demands and ensure compliance to FDA regulations.

At the facilities in Parets del Vallès, where the end product is manufactured, a series of modifications were made. Artificial vision equipment was installed in the dosing line to control the primary bag and in the packaging area to control the correct insertion of the prospectus into the individual box, in compliance with FDA regulations. The robotic palletizer that deposits the product in autoclave trolleys was adapted prior to entering the terminal sterilization phase (see Figure 1). Due to the properties of the material used for double bagging the product, it was necessary to adapt the artificial vision equipment that transmits the coordinates to the automatic palletizer. Figure 2 shows the automatic overwrapping system used for double bagging. Other production processes, such as secondary packaging, are in the process of being automated. A single boxing machine that will be able to handle the required production for this customer will be installed.

Changes were introduced at the production plant in Murcia, where the primary bag and the twist-off valve are produced. In-line printers for the thermal images of the primary bag were modified to meet the labeling requirements for the different countries where the product will be sold. In addition, the twist-off valve mold was redesigned, and the corresponding validation was conducted. All these modifications required efficient coordination between the different production areas involved, so that they could be properly implemented on time.

Handling last-minute issues
A few weeks prior to launch, the regulatory authorities of one of the countries where the product was to be launched requested a full analysis of all the raw materials included in the first commercial lots. This request involved making an analytical transfer from the client to Grifols. Although the responsibility of the CMO was initially limited to the identification of the analytical profile index, the CMO adapted and undertook this additional step of raw material analysis to speed up the project.

Partnership leads to success
The difficulties that appeared during the course of the project did cause some delay, but because a margin of a few months had been planned, Grifols was able to manufacture and monitor the lots before the deadline. The client thus won the race against the clock and launched the generic product on the US market.

Marga Viñes is senior product manager of Grifols Partnership, a business area of Grifols International, Barcelona, Spain, marga.vines@grifols.com.


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