Developing and bringing a biological drug to market is very expensive and involves risks in every stage of the project. Primary packaging is an integral part of the drug and selecting the right packaging components is crucial for the success of the project. Drug developers and manufacturers who do not understand the full impact of primary packaging on their drug product are taking a significant risk in terms of product stability, patient safety and regulatory scrutiny. The new biological drugs also demand innovative primary packaging solutions.
Learn about the next generation of packaging solutions for biological drugs to avoid the common pitfalls and put your biological drug on a “fast track” to success.
• 1-3 days deliverytime for secondary packaging
• No minimum/No maximum quantity
• Near-site/On-site production
• Lower cost per box
• An innovative answer to cGMP Annex 1 requirements on vial sealing
• Improving process efficiency by suppressing vial crimping
• Creating an integrated ecosystem to enhance adoption of RayDyLyo
• Ready to Use packaging components: Market evolution
• Moulded Glass Vials RTU: why do we need them?
• The strengths of moulded and especially with new products
• Value Proposition of SGD Pharma Sterinity Platform
• How artificial intelligence helps to optimize respiratory therapies by improving adherence and inhaler technique
• How to make medical information clear and improve patient engagement with connectivity and digital solutions
• Importance of compliance for treatment efficacy
• Innovative devices for nasal delivery: Advancia, new generation pump platform
• Correlating enhanced compliance and patient experience
• How QbD process differs from traditional process in terms of focus, approach, and quality assurance
• How QbD process is needed in order to meet demands of advances in: biologic and complex small-molecule drug products, high-value treatments, stricter regulations, and self-administration systems
• How QbD process can be applied to design and manufacture of plungers, resulting not only in plungers of higher quality, but better performance.
• Overview of VH2O2 low temperature terminal sterilization process and applications
• How to approach process validation in low temperature terminal sterilization applications
• Overview of VH2O2 low temperature material transfer decontamination applications
• How to approach validation of atmospheric VH2O2 material transfer chambers
• System integration of a prefillable syringe in an autoinjector
• Safe and effective drug delivery to patients
• Benefits of system integration and lessons learned after 8 years of BD Physioject™ commercialization
Packaging quality control is a delicate process, especially in pharma where regulatory bodies rule and customer safety comes first. Automation is proven to dramatically decrease the likelihood of text mistakes in regulatory submissions, inconsistencies in digital artwork files early in the revision process, and print defects/ typos on the printed samples before going to market. Recalls may still be a reality in this day and age, but so are tools that protect against them.