SFF
Driven by the increasing prevalence of eye diseases, the ophthalmic drug delivery market is projected to be valued at $23.4 billion by 2030, growing with a compound annual growth rate (CAGR) of 8.3% from $12.1 billion in 2021 [1]. Ocular multi-dose containers are the most common ophthalmic delivery method, typically containing 10-15 mL of product for multiple uses over a prolonged period.
However, ophthalmic manufacturers and drug developers are increasingly exploring unidose container formats as alternatives to standard multi-dose to provide more convenient delivery options in the growing market. Blow-fill-seal (BFS) is an innovative technology that can be used to produce unidose containers for the sterile fill and finish of ophthalmic therapies.
The potential of BFS in ophthalmics
In BFS, polymer pellets are used to form, fill and seal plastic containers in a single, automated process. BFS containers are filled with a single dose of product then immediately and automatically sealed, forming an air-tight, sterile container with a reduced reliance on preservatives and minimised contamination risk. As the BFS process occurs in a sterile, enclosed area inside the BFS line without human intervention, BFS containers can meet the demands of ophthalmic drug products.
As the eye is highly sensitive, ophthalmic drug products and container systems must be manufactured in sterile conditions for patient safety. Microbial contamination can lead to eye infections and particulate contamination can irritate or damage the eye. Containers must also maintain product sterility and prevent leakage throughout the entire product lifecycle.
However, when exploring alternative container formats such as BFS, ophthalmic drug developers must consider formulation development, analytical method development and product-filling at both pilot and commercial scale. Partnering with contract development and manufacturing organisations (CDMOs) can provide the expertise, experience and facilities to help with the development and manufacturing of BFS ophthalmic products.
To discover more about BFS in ophthalmics, read the full article by our expert, Vincenza Pironti, Head of Business Development at Recipharm, which explores how ophthalmic treatment delivery can be enhanced using BFS unidose.
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