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Design of a Process and Phase III Manufacture in 15 Months

Background

A US-based public biotechnology company, with extremely aggressive timelines, approached Cobra with the task of making significant modifications to a process to be transferred from a third party manufacturer for the manufacture of a BL2 containment-level microbial organism that had traditionally been grown on a meat-derived media. 

Objectives

The aim was to bring current technology to the process, increasing robustness and regulatory compatibility, suitable for Phase III manufacture of a product granted orphan status by the FDA.

Challenge

The challenge was to manufacture a cell bank, design a process for manufacturing the protein product using animal-free media and produce sufficient quantities and grade of material to support toxicology and regulatory bridging studies. During the development it
 

was apparent in the absence of meat-derived media that the target protein was being degraded by constitutively expressed proteases.

Method / Solution

Cobra’s process development team devised a scalable robust process suitable for Phase III manufacture to combat the degradation issues observed so that the product would meet the required specification. Once the process was defined, Cobra completed a scale-up development run, an engineering run and the Phase III GMP run within 6 months. Cobra worked closely with the customer through regular visits at both company sites and also welcomed the permanent placement of a Client representative on site at Cobra to expedite joint decision-making during the programme.

Benefit

The customer was able to provide material for their toxicology study and Phase III clinical trial in an ambitious time frame of 15 months using an improved process that was more acceptable to the FDA.
This product is now available commercially in Europe and the US.
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