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Biopharmaceutical formulations for pre-filled delivery devices
Jan Jezek1, Nicholas J Darton, Barry K Derham
1Arecor Ltd., 2 Cambridge Science Park, Cambridge, CB4 0FE, UK. jan.jezek@arecor.com
Pre-filled syringes offer convenient biotherapeutic delivery but pose formulation challenges. Careful material selection and advanced formulation strategies are crucial for ensuring drug stability in these devices.
Area of Science:
- Pharmaceutical Science
- Biotechnology
- Materials Science
Background:
- Pre-filled syringes (PFS) are gaining popularity for biotherapeutic delivery due to convenience and cost-effectiveness.
- Technical challenges include device design and developing stable liquid formulations compatible with PFS.
- Assessing material compatibility and optimizing process conditions are critical for biotherapeutic stability in PFS.
Purpose of the Study:
- To review key stability considerations for biotherapeutics in pre-filled devices.
- To discuss the impact of stress conditions and packaging interactions on biotherapeutic stability.
- To highlight the role of formulation in controlling biotherapeutic stability within PFS.
Main Methods:
- Literature review focusing on biotherapeutic stability in pre-filled devices.
- Analysis of physical and chemical stability under various stress conditions.
- Examination of formulation strategies for enhancing stability.
Main Results:
- Biotherapeutic stability is influenced by interactions with the primary packaging system.
- Stress conditions can impact both physical and chemical integrity of biotherapeutics.
- Formulation plays a pivotal role in maintaining stability.
Conclusions:
- A long-term shift towards polymer primary packaging for drugs is anticipated.
- Formulation is critical for successful biotherapeutic products in PFS, especially with concentrated biologics.
- Novel formulation technologies will be increasingly important for PFS development.
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