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HomeCompaniesShamrock BioPharma (Demo)
Shamrock BioPharma (Demo) logo

Shamrock BioPharma (Demo)

VERIFIED
Sterile fill-finish & biologics manufacturing from Galway, Ireland
Galway, Ireland Biotech 240 employees Founded 2012 shamrock-biopharma-demo.ie ↗
3 Products & services
3 Certifications
2 Sites
240 Employees

About Shamrock BioPharma (Demo)

Who we are

Shamrock BioPharma is a Galway-based contract manufacturer specialising in sterile fill-finish and lyophilisation of biologic medicines. From our 12,000 m² campus at Ballybrit we support clinical and commercial programmes for partners across Ireland, the EU and the United States.

This is a demonstration company profile used to showcase the Priya Life Science corporate portal.

Capabilities

  • Aseptic vial and pre-filled syringe filling (batch sizes 2,000–120,000 units)
  • Lyophilisation cycle development and commercial freeze-drying
  • ICH-compliant analytical, stability and sterility testing
  • Cold-chain packaging, labelling and QP release

Quality first

Our site operates under an HPRA-issued EU GMP licence and passed its first US FDA pre-approval inspection in 2025 with no critical observations.

“Quality is not a department here — it is the production line itself.” — Dr. Aoife Brennan, CEO
Sector
Biotech
Headquarters
Galway, Ireland
Founded
2012
Employees
240
Markets served
Ireland, EU, United States
Facilities
2 sites

Milestones

2012
Founded in Galway
Company incorporated with a 12-person team and a single clinical filling line at Ballybrit.
2017
First HPRA GMP licence
Commercial manufacturing authorisation granted for sterile fill-finish.
2021
Lyophilisation expansion
Line 2 commissioned, adding 30 m² of freeze-drying shelf capacity.
2025
US FDA inspection passed
First pre-approval inspection completed with no critical observations.

Leadership Team

Dr. Aoife Brennan

Chief Executive Officer
Former VP of Biologics Operations at a top-10 pharma; founded Shamrock BioPharma in 2012 to bring commercial fill-finish capacity to the west of Ireland.
inLinkedIn

Dr. Marcus Chen

Chief Scientific Officer
Leads lyophilisation cycle development and analytical sciences. 18 years in sterile product development.

Niamh Gallagher

VP, Quality & Regulatory Affairs
Qualified Person (QP) and former HPRA inspector; owns the site quality system and regulatory strategy.

Products & Services

All Manufacturing Development Quality
Manufacturing

Sterile Fill-Finish Services

Aseptic vial and pre-filled syringe filling for clinical and commercial biologics, batch sizes 2,000–120,000 units.

asepticvialsPFS
Development

Lyophilisation Development

Freeze-drying cycle design, scale-up and commercial lyophilisation for temperature-sensitive molecules.

lyophilisationfreeze-drying
Quality

Analytical & Stability Testing

ICH-compliant release testing, stability programmes and sterility assurance from our on-site QC laboratories.

QCstabilityICH

Certifications & Awards

EU GMP Certificate
Issued by the HPRA — sterile medicinal products
ISO 13485:2016
Quality management — combination products
Pharma Industry Awards 2025
Fill-Finish Site of the Year — Finalist

Facilities

In the News

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