Aldevron – Innovative Manufacturing: Dedicated to the Cell and Gene Therapy Industry

• Move from research grade to cGMP without having to rebuild your approach at each stage  
• Make early decisions that still hold up as requirements increase  
• Reduce delays by keeping materials, processes and teams aligned  
• Use GMP‑Source™ grade as a practical step between research and full cGMP  
• Keep a clearer, more controlled path as your program progresses

Most programs don’t run into issues at the start—they run into them when things need to scale. 

What worked well early on doesn’t always translate cleanly into cGMP. Processes need to be revisited; materials don’t quite line up anymore, and teams end up going back over the same ground just to keep things moving. 

There’s usually nothing wrong with the science—it’s how the pieces were set up. 

A better way to approach it is to think about the full path earlier. 

At Aldevron, research grade work is set up with what comes next in mind. That makes it easier to carry decisions forward, rather than having to redo them later. As programs move on, GMP‑Source™ grade gives you a way to move into early clinical stages without jumping straight into full cGMP, while keeping everything aligned. 

From there, cGMP manufacturing sits within the same quality framework, so the transition isn’t a reset—it’s a continuation. 

It’s just a more joined up way of working. 

Less rework, fewer surprises, and a bit more control as things get more complex. 

Start in a way that still works later 

What you set up in research should carry through to cGMP 

Don’t rebuild at every stage 

Keep decisions, data and processes moving forward 

Use GMP‑Source as a step, not a jump 

A more practical way to bridge into early clinical work 

Keep things aligned as you go 

Fewer handoffs mean fewer delays 

Stay in control as it scales 

One framework across stages makes progression more predictable