Thinking August 12, 2025

Why low volume pharma projects struggle to find the right assembly & packing partner – and how  Ensera fills the gap

Marcel Baumann
By
Marcel Baumann VP Sales Pharma USA

The market shift that’s changing everything

Precision medicine, orphan‑drug incentives and fast‑tracked biologics have flipped the traditional pharma‑supply equation on its head. Instead of blockbuster drugs that run for years, many launches now require only thousands or even hundreds of packs in total, often in multiple configurations and languages. Specialty drugs are the fastest‑growing segment of the market, creating a surge in demand for both small batches and low to medium volume projects. 

Why traditional CDMOs may turn you away

Large CDMOs optimize overall equipment efficiency (OEE) by keeping lines running at maximum speed for long stretches. Projects with lower volumes are often unattractive because they mean: 

  • More line changeovers and line clearances  
  • More product‑to‑product artwork and serialization changes 
  • Less margin to amortize set‑up and regulatory overhead across the product’s lifetime 

Under that business model, your 25,000 unit lifetime campaign, or a one‑off 5,000 unit replenishment order, could simply be uneconomical. Yet these projects are exactly what today’s specialty‑drug, orphan‑drug and life‑cycle‑management strategies demand. 

The hidden cost of “we can’t help you”

When your supply‑chain team spends months hunting for capacity, three things typically happen: 

  1. Timelines slip – Launch windows and clinical milestones drift while you wait in a queue. 
  2. Inventory risk rises – You’re forced to overproduce drug substance to protect against missed slots. 
  3. Quality compromises creep in – Last‑minute line transfers increase the probability of deviation. 

In other words, the real price of small‑volume work isn’t the piece‑part cost, it’s strategic delay. 

What a right‑sized partner looks like

A specialist in low‑ and medium‑volume projects should be built for agility first: 

Must‑have capability  Why it matters for low‑total‑volume programmes 
Manual‑to‑semi‑automated lines  Quick changeover and economically viable setup for 1,000 – 50,000 batches or entire life‑cycle runs 
Multi‑SKU, multi‑format expertise  Supports vials, pre-filled syringes, autoinjectors, kits and language variants without re‑engineering 
Global GMP footprint  Enables regional supply, even when lifetime demand is modest 
Cold‑chain storage  Allows handling of temperature‑sensitive biologics and combination devices 
Responsive tech‑transfer teams  Weeks, not months, from URS to PQ. This is crucial when total market demand is time‑sensitive and short‑lived 

Where Ensera fits

Ensera’s facilities and processes are designed around flexibility, not retro‑fitted to it. 

  • Final assembly and secondary packing of vials, pre‑filled syringes and autoinjectors from pilot lots up to mid‑commercial volumes. Grade B/C/D cleanrooms across Europe and North America. 
  • Manual, semi‑automated and fully automated lines that scale with your demand curve. Ideal whether you need a single 3 ,000 unit lot or a steady cadence of 20,000 units a year. 
  • 25 years of regulated packing experience and approved partner status with the world’s leading autoinjector platform suppliers. 

What that means for you

  • Speed to clinic or market. Rapid and effective tech transfers, giving you back precious development calendar. 
  • Lower total‑landed cost. Right‑sized lines + fewer write‑offs = visible P&L impact. 
  • Peace of mind. Our global Quality System and serialization infrastructure keep auditors, and your quality team, comfortable. 
Person with laptop in a medical lab.

Ready to de‑risk your next small‑batch or low-to-medium volume launch?

If your CDMO says your project is “too small to run,” talk to us. We built our business around the projects that others decline, and we’ve proven that small batches and limited lifetime volumes deserve big‑picture thinking. 

Fill in your details here and we’ll be in touch asap. 

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