DeepDivers

After 35 years in pharma, and involvement in one of the largest successful product transfers I’ve seen (27 trial batches. Zero commercial failures.), here’s the truth:

Product transfers succeed because of people — not just processes.

Here’s what actually sits behind every smooth transfer 👇

Step 1: Scope your CMO / Partner Properly

Before you even think about transferring a product, ask the hard questions:

• Does this site truly understand the science?
• Do they have the manufacturing capability?
• Do they demonstrate the right quality mindset?

👉 Capability assessment is non-negotiable.

Skipping this step just pushes risk downstream—where it’s far more expensive.

Step 2: Trials are Everything

Run them. Always.

My recommendation: start at ~50 % of commercial scale.

It’s the sweet spot where:

• Real risks emerge
• Failures are still manageable
• Learning happens fast

Every failure in trials is one less failure in commercial production.

That mindset alone changes outcomes.

Step 3: Regulatory & Stability Readiness

This is where confidence is built and proven.

• Dossiers
• Stability studies
• Documentation and data integrity

You’re demonstrating that the product will perform consistently, under real conditions, not just on paper.

Step 4: Commercial Launch Readiness

Now it’s execution time:

• Shelf-life supported by stability data
• Finalised artworks
• Supply chain fully aligned

At this point, launch readiness should feel boring… because the hard work is already done.

The Real MVP: The Project Manager

The best PMs aren’t the loudest technical voice in the room.

They:

• Create structure
• Enable honest conversations
• Let experts do their best work

Facilitation beats domination. Every time.

The Human Element Most Transfers Get Wrong

The best product transfers aren’t the ones with perfect Gantt charts.

They’re the ones where:

• 🤝 Donor and receiver teams genuinely trust each other
• 🧠 Joint planning sessions are brutally honest
• 🛑 People feel safe saying: “We don’t know this yet”

Technology helps.
Processes guide.
But people deliver.

Over to you

What’s been your biggest product transfer challenge?

• Trust between sites?
• Trial batch sizing?
• Regulatory timing and pressure?

Drop your experience below—I’d love to hear what’s worked (and what hasn’t).

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Authors Note: Wilson Prasad also known as user name muefatiaki1966 is trying to leverage his extensive experience within the industry to educate and invoke discussion for topics of interest.