Is it Feasible to Outsource Packaging for Stability Studies?
Business Management Review |
Developers might also purchase small-scale systems to manufacture packaging for balance assessments 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 (personalized), as in patient-specific autologous cell and gene therapies. A transformation from manufacturing to agile, small-scale personalized 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 aluminum 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 scaled up the product.
Stability studies are necessary for material selection, process validation, and medication lifecycle studies. While post-commercialization studies will use the finished product and packaging, expedited studies require a quick turnaround of 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:
Cross-contamination prevention when manufacturing powerful or experimental drugs
No need to swap lines for small batches
No need for extra tooling
No delays due to stability chamber availability.
Benefits for smaller developers include:
No need to buy equipment or infrastructure
No auditors, no licenses
Achieve milestones faster
Smaller developers' workers often have biological, chemical, or medicinal backgrounds but may lack extensive knowledge of packaging procedures.
If one decides to outsource packaging for stability testing, here are some critical questions to ask:
How fast can one turn around?
Cost? Note that packaging may include additional charges like design services and tooling.
Minimum order? This topic should be raised early in supplier qualification as small-batch packaging may not be their forte.
Where is the stuff? Some materials have extensive lead periods, so search for a supplier who has a wide range of material grades.
Material selection skill? Working with a provider who can guide one through the various material grades is beneficial.
Design experience? A good provider will quickly grasp needs and meet them with existing tools, lowering overall project costs. Having worked in larger production environments can help create a scalable package.
Cleanroom prowess? Understanding the environmental possibilities will help decide the supplier's drug capabilities.
Testing for leaks? Non-destructive leak detection is helpful for stability trials since it guarantees all packs are leak-tight before stability, removing package integrity as a risk/concern if outliers are discovered.
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