As the complexity of combination products and delivery systems grows, so does the challenge of selecting suitable components, requiring a deeper understanding of integration, compatibility and regulation constraints.
Glass primary packaging is at the core of any drug delivery injection system playing a crucial role, as it is the main point of contact between the drug and the device, yet its importance is often overlooked.
Connecting the three dimensions of the container-closure system ― glass component, drug formulation/substance and rubber component ― represents a challenge for biopharma companies.
Thanks to our unrivalled glass expertise, SG US Technology Excellence Center can cover one of the most binding and critical decisions: the glass container choice from the early stage up through the integration into devices.
SG US Technology Excellence Center works to ensure a two-fold compatibility level:
Opening in Boston, Massachusetts in 2020 will provide biopharma companies with integrated analytical services and effective project management to support the drug development, its commercial and lifecycle management helping them navigate regulatory bodies requirements and overcome container-closure systems hurdles.
Analytical services to test primary container for quality, compatibility, and compliance with regulatory standards and its integration into medical device
Medical device testing on functionality and performance characterization. Understanding of the core technology, sub-assembled components functionality and primary container interaction through tailored methods and simulation/math modelling
Prototyping, and lab-scale manufacturing of primary containers and drug delivery systems
Small scale fill & finish (non GMP, not FHU), and assembly dedicated exclusively to stability/pre-aformulation screening studies to support selection of CCS/device solutions & EVT/DVT functional testing
SG US Technology Excellence Center services are provided either in-house or through a consolidated network of trusted partners, all managed under one single point of contact and accountability.