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Developers may purchase small-scale equipment to manufacture packaging for stability tests in-house or outsource production. Manufacturers should weigh the advantages and disadvantages of both techniques.
FREMONT, CA: Personalised medicine targets therapies to specific patient groups (stratified) or individuals (personalised), as in patient-specific autologous cell and gene therapies. A transformation in manufacturing to agile, small-scale personalised production will be required to deliver these medicines promptly. This new reality will be enabled by Industry 4.0, which combines connectivity, advanced analytics, automation, and advanced manufacturing technologies. Fast, efficient, small-batch packaging is critical in this new paradigm.
The significance of material selection
Stability studies are crucial for regulatory approval and novel medications where material selection can be difficult. It is usual for developers to over-specify their blister-pack material. They may know from previous experience that aluminium provides the best barrier; therefore, they may request it regardless of material sensitivity.
Contract packaging vendors can advise on material selection and suggest alternatives such as high barrier thermoform, less expensive materials, faster to form, more accessible to fill, and smaller. Stability studies will then determine what barrier is required, such as thermoform or cold form. Trials with different blister packing materials could save time and money when the product is scaled up.
Stability studies are necessary for material selection, process validation, and medication lifecycle studies. While post-commercialisation studies will use the finished product and packaging, expedited studies require a quick turnaround, small-batch packaging to ensure compliance and effectiveness.
Factors to consider while outsourcing
Whether CDMOs or small-cap companies create pharmaceuticals, outsourcing packaging for stability studies must be carefully considered. In both circumstances, the benefit of outsourcing may outweigh the risk of protecting intellectual property (particularly with experimental, high-value medications).
Among the primary advantages of outsourcing packaging for stability studies for CDMOs are:
Benefits for smaller developers include:
If one decides to outsource packaging for stability testing, here are some critical questions to ask: