By 2020 biologics are expected to be 27% of the overall drug market versus 22% registered in 2013: this progressive growth of biologics, including biosimilars, are driving the need for new container platforms suitable for more concentrated drug formulations, featuring higher viscosity, complex and sensible compounds.
The evolution in the drug development approach entails that the primary packaging containers industry has to help and support providing to pharma companies flexible solutions to cut TCO and to reduce the time-to-market starting from the early development stage.
In 5-15% of cases, drug formulations have a high to very high sensitivity to one or more of the components of the primary container; the main issues consist of:
- Silicone oil droplets/ particles release
- Drug/surface interactions leading to protein aggregation or glass delamination
- E&L issues with rubber components
To better understand the impact related to the change from one glass barrel to another during development stages (e.g. from a Vial to a PFS), Ompi has conducted 30 in-depth interviews with pharma industry experts: the result showed that delays associated with failed stability tests in PFS have a huge impact on delays to the market.
The Alba Platform has been design to bypass all the above-mentioned issues and it represents the latest innovation in the pharmaceutical primary packaging container industry dedicated to highly sensitive biologics and to ophthalmic drugs.
Alessio Bonati
Head of New Product Development
Master’s degree in Electronic Engineering from the University of Ferrara and MBA degree from Bologna Business School. Mr. Bonati has worked in the last 11 years for international companies in several different businesses, but with roles always related to portfolio management and business development.
He is currently Head of New Product Development EZ-fill in Ompi, a pharmaceutical glass primary packaging company, responsible of new product developments for all the business lines related to Ompi’s portfolio, from ampoules to vials, from cartridges to syringes, in "ready to use" format.
- New container platform for biologics and ophthalmic drugs with high sensitivity to primary packaging interaction
- Ultra Low Particle Level, reduced extractables and leachables and no delamination propensity for vials
- Container platform suitable to de-risk the drug development process
- Sterile RTU containers and process
- R&D Manager
- Packaging Development Manager
- Buyer
- Supply Chain Manager
- Quality Manager
- Engineering specialist
- Chemical Analysis Specialist
- Biotechnology Developer
