SFF
The biologics sector is growing rapidly, with 22 products approved by the US Food and Drug Administration (FDA) in 20231. The global biological drug market was valued at $322.8 billion in 2021 and is projected to be worth $689.59 billion by 2030, growing at a compound annual growth rate (CAGR) of 8.8%2.
Biologics are generally administered via injection because of their size and sensitive nature. The size of biologics leads to bioavailability issues, making it more challenging to produce oral or inhalation formulations. The sensitivity of biologics also means they can be vulnerable to degradation in the gastrointestinal tract if administered orally. These factors mean that biologic drug products are usually formulated for injection, manufactured, filled, and finished in a sterile environment, following Annex 1 of the EU Good Manufacturing Practice.
As the biologics market continues to grow, alternative container formats for injectable products beyond traditional vial filling are being explored. Alternative container formats can help to ensure the unique needs of each drug product are met and patients receive optimal treatment. Each alternative format has different characteristics and advantages, making them suitable for specific therapies and use cases:
- Pre-filled syringes (PFS): Using single-dose biologic PFS can streamline administration, minimising the risk of incorrect dosing, helping reduce product waste, and opening up self-administration to a wider range of treatments.
- Blow-fill-seal (BFS): Lightweight plastic containers blow-formed, filled, and sealed in a sterile environment are ideal for offering single doses, enhancing self-administration, reducing product waste, and streamlining production and transport costs.
- Inhalation administration: Inhalation offers ease of administration advantages and enhanced patient comfort, making it beneficial for the localised treatment of chronic pulmonary diseases where patient compliance is crucial.
Container format selection depends on important factors, including product modality and administration route. Getting container selection right at the earliest phase of drug development helps to ensure product success and the delivery of treatments to patients. Partnering with contract development and manufacturing organisations can help developers to make informed decisions and optimise the performance of their biologics products.
To learn more, read the full article by our expert, Vincenza Pironti, Head of Business Development at Recipharm, exploring the key considerations when selecting a container format for sterile drug products.
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