Orphan Drug Commercialization on the SA25 Filling Line

Orphan drug manufacturing presents unique challenges—small batch sizes, high complexity, and the need for precision at every step. At BioCina, we’re committed to supporting innovative biotech companies by providing flexible, world-class solutions tailored to niche and underserved markets.

Our state-of-the-art SA25 GMP filling line, located at our Perth facility, is designed specifically for small-scale commercial production. Fully automated and Annex 1 compliant, it delivers precision aseptic filling with the highest standards of quality, safety, and reliability.

With over 30 years of manufacturing excellence and regulatory approvals for over 98 countries, BioCina is a trusted partner in delivering critical therapies to patients who need them most.

Our Orphan Drug Capabilities:

Small Batch Flexibility: From 0.5L to 500L (100 to 20,000 units)
Multiple Formats: Glass vials, pre-filled syringes (PFS), cartridges
Fill Volumes: Ranging from 0.5mL to 50mL
Advanced Features: Nitrogen blanketing, fully automated aseptic fill, Annex 1 compliance

BioCina is built to serve where others hesitate. With a 97% on-time delivery rate and a relentless focus on quality, we treat every orphan batch with the urgency and care it deserves. Let us help bring your therapy to life—faster, safer, and with confidence.