Thank you for Subscribing to Business Management Review Weekly Brief
I agree We use cookies on this website to enhance your user experience. By clicking any link on this page you are giving your consent for us to set cookies. More info
Thank you for Subscribing to Business Management Review Weekly Brief
By
Business Management Review | Sunday, November 28, 2021
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
Stay ahead of the industry with exclusive feature stories on the top companies, expert insights and the latest news delivered straight to your inbox. Subscribe today.
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:
Benefits for smaller developers include:
Check Out This : PROPTECH OUTLOOK
If one decides to outsource packaging for stability testing, here are some critical questions to ask:
More in News