Global demand for GLP-1 therapies is unprecedented, CDMOs must deliver speed, scale, and regulatory readiness at once.
From the rapid rise of GLP-1s (and related GIP/Amylin pathways) to tighter regulatory expectations, pharma companies face mounting pressure to manufacture faster, at scale, and in full alignment with Annex 1. Capacity constraints across drug product and delivery devices are real and expansion without compliance puts quality at risk. Traditional, rigid CDMO platforms can limit progress when adaptability is essential.
Download this article to see how leading CDMOs are modernising facilities, safeguarding quality, and building flexible, long-term partnerships to meet surging injectable demand.
What You’ll Learn Inside
- The Market Shift – Why GLP-1s are driving a once-in-a-generation spike in injectable demand and why capacity and device bottlenecks persist.
- The Compliance Challenge – How the revised EU GMP Annex 1 raises the bar on sterile operations, making regulatory readiness as critical as speed.
- Where CDMOs Fall Short – The limits of rigid, one-size platforms when products and partners need nuanced, fast-moving support.
- Future-Ready Solutions – How site modernisation, flexible facility design, and device compatibility enable scale without sacrificing quality.
- Real-World Results – Post-Annex-1 inspections passed and significant capacity (e.g., 80M+ vials/yr, 40M+ cartridges/yr, 600M+ syringes/yr) to meet global demand.
- 5 Must-Haves for a CDMO Partner – Regulatory readiness, injectable expertise, device assembly capability, rapid/controlled tech transfer, and strategic co-investment for capacity.
