Aldevron Breakthrough Blog

GMP Protein Manufacturing: Aldevron Delivers Excellence

Aldevron has offered off-the-shelf GMP protein products since 2017, but our customers are often surprised to discover that we can also manufacture custom GMP proteins.

In fact, we’ve been making custom E. coli proteins since 2009. We’re always ready to support new clients with protein development – starting with just a DNA sequence and progressing through the process to GMP manufacturing.

Why use Aldevron for custom proteins?

First and foremost, we have over a decade of experience in E. coli expression and purification. Many of our scientists are founding members of Aldevron’s protein unit, and we’re able to leverage their expertise to save time on development.

Another big reason is our competitive timelines. We're not as large as many companies in the industry, which means we’re flexible about our development process. We don’t force custom proteins through rigid platform experiments – we work off the scientific data. As a result, we can typically move from process development to manufacturing a GMP product in only 12-14 months.

How do we start on your custom protein?

We typically start with one of two paths when manufacturing custom protein. The first path is a full development process — starting with as little as an electronic DNA sequence. Alternatively, if our client already has a process in place, we can take that to GMP manufacture through a technology transfer.

We take an iterative approach to projects, with the first step being to scope out the work. The next piece of the puzzle is to create a technical work plan outlining the specific steps needed to get the project to completion. This is when our customers are blown away by our depth of knowledge as demonstrated through the experiments we choose and the quality of the work that we do.

What happens during development?

Our standard development process kicks off with codon optimization, gene synthesis and cloning. We identify the best expression conditions for that protein through a multi-condition shake flask expression screen. The highest expressing conditions are repeated in a larger expression volume.

The next step is to optimize protein expression in our E. coli host strain for fed-batch fermentation. The goal is to, not just develop the process, but to ensure scalability and reproducibility at a manufacturing scale. To do that, we build on the shake flask expression results by testing with several different fermentation conditions and move forward with the best one. We can scale up at volumes of 20L to 1,000L.

At each stage, we benefit from our scientists’ years of experience as well as cutting-edge analytical tools. We take a Quality by Design approach to our research-scale studies, testing multiple different factors at the same time to ensure we understand how the parameters will impact the client’s critical quality attributes.

Each customer’s production is supported by a custom QC panel, and we offer stability studies and secure storage services as well.

What about complex proteins?

We wish every protein project was straightforward, but – unfortunately – that’s not always the case. We have decades of combined experience in expressing, purifying and stabilizing inclusion bodies and other complex proteins. Whether you’re developing a simple protein, or a more complex one, you’re safe in our hands.

Aldevron: A perfect fit for your project?

With some of the fastest timelines in the industry, we’re able to get our customers to GMP manufacturing in months – bringing new therapeutics to patients more swiftly.

If you’re a company working on E. coli-based projects at a 20L to 1,000L operating scale, then we may be a perfect fit for you.

Get in touch to find out more!

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Justin Byers

Justin Byers

Justin Byers is Aldevron's Client Relations Sr. Manager for GMP Custom Protein Services and has a demonstrated history of working in the biotechnology industry. He is responsible for building strategic long-term relationships by understanding clients’ technical requirements, clinical and commercial goals, and promoting appropriate custom manufacturing solutions. He collaborates with our commercial teams by creating strategic plans, technical marketing collateral, and sales training material for GMP Custom Protein Services. Byers earned his Bachelor of Science in Biochemistry and Molecular Biology from Illinois State University.

Topics: Protein, Clinical Grade Manufacturing/cGMP