GE Healthcare and the Bio Affinity Company (BAC) have extended their biopharmaceutical partnership to develop purification media for Factor VIII (FVIII) for the treatment of haemophilia A.
In the third project since the companies announced their collaboration in biopharmaceutical purification in October last year, GE Healthcare will be working with BAC to develop and market affinity chromatography media for the purification of therapeutic recombinant Factor VIII.
The FVIII product, developed using BAC's CaptureSelect ligand technology, should be available to customers through GE within a matter of months.
According to BAC CEO Laurens Sierkstra, the highly specific purification media offers several advantages to manufacturers:
"This is a generic media, so will hopefully offer big advantages to the end-user," he said in an interview.
"It's an over-the-counter product so saves the manufacturer having to produce the media themselves, and offers not only a cost-benefit and ease of buying, but the media are highly robust and can be recycled even more times than many manufacturers may be used to."
The CaptureSelect technique is based on affinity ligands created by a technology based on camelid-derived single domain antibody fragments. Manufactured using a high-yielding proprietary yeast-based expression system, these ligands offer increased stability and broad antigen-specific binding compared to traditional affinity ligands, according to the company.
The technique can be applied and customised for use in the manufacture of a variety of biopharmaceuticals, including recombinant proteins, antibodies, antibody fragments and viruses.
GE and BAC have already worked on two projects previously, the first being an IgG select ligand that is due to be launched officially in June, and an adeno-associated virus (AAV) purification product that is already available on the market through GE.
This latest product is intended to enable efficient process-scale purification of FVIII for the prevention and treatment of bleeding in patients with haemophilia A, also known as Factor VIII deficiency or classic haemophilia.
"Our biopharmaceutical manufacturing customers are demanding greater and greater process efficiency to reduce costs and increase throughput, while maintaining high yields and product authenticity," said Klas Allmér, director of the custom designed media group at GE Healthcare.
"We have been impressed with our previous collaborations with BAC and look forward to further extending our product range to include highly-specific recombinant FVIII purification ligands."
The large-scale processing products produced through BAC's technology platform are currently available exclusively through GE, though the company has also shown an interest in bringing smaller scale products onto the market independently, and is currently in the process of developing a "complete antibody toolbox technology" for the industry, according to Sierkstra.