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Developing a Robust and Scalable cGMP Protein Manufacture Process

Background

A UK customer had an interferon product produced in a cell line licensed from a company in Asia. The customer did not have the internal resources to manufacture the product and needed a CMO whose staff had experience in cytokine production.

Objectives

Cobra was commissioned to develop a robust and scalable manufacturing process that would deliver a product to meet the EU pharmacopoeia quality standards, and to produce protein for Phase I clinical trials.

Challenge

After technology transfer, Cobra’s scientists applied their expertise and innovative molecular biology skills to efficiently re-clone the gene into an accredited cell line suitable for cGMP manufacture. They then developed and validated a scalable process.
During process development, Cobra scientists discovered that the product was partially acetylated in E.coli meaning non-compliance with

EU pharmacopoeia quality standards. This was a new discovery as only animal cell lines were previously thought to acetylate recombinant proteins.

Method / Solution

The Cobra team designed and developed an innovative, scalable HPLC method to remove this contaminant.
Cobra’s account manager ensured that regular meetings were held with the customer to keep track of this complex program and ensured excellent communication with the scientists, the customer and the regulatory authorities. The well coordinated effort between the parties helped to ensure an efficient and rapid execution of the program.

Benefit

Multi-gram quantities of the protein product were delivered to the customer on schedule and with the necessary regulatory documentation for Phase I clinical trials.

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