Product Development Plasma Products

Contact person: Anky Koenderman PhD

The product development strategy of Sanquin Plasma Products aims primarily at maintaining the state-of-the-art level of its plasma derivatives portfolio and production processes. To that end, the product and process development program is regularly evaluated and updated if needed. Besides, opportunities for development of new (plasma) products are being explored in feasibility studies which may evolve into full-blown development projects when considered to be economically feasible.

Our Activities

 

Development of new products

Holotransferrin and Apotransferrin

Project leaders: H. ter Hart and I. Prins
Development of a manufacturing process for holotransferrin was realized in close collaboration with L. von Bonsdorff, Sanquin Oy, Finland. Holotransferrin will be used by Mebiopharm for a new drug product, Oxaliplatin-encapsulated transferrin-conjugated PEG-liposomes for targeting Oxaliplatin (I-OHP) to colon cancer cells via cancer manifesting transferrin receptors. Clinical studies using this new product are started in 2009 and are ongoing.

As spin-off of the development of holotransferrin, an apotransferrin product was developed. Apotransferrin was manufactured using the manufacturing installation for holotransferrin as well. A clinical study with this product was started in 2010.

Inter-Alpha Inhibitor Protein

Project leader: H. ter Hart
In close collaboration with ProThera Biologics, East Providence, USA a project was started to develop a manufacturing process for an Inter-Alpha Inhibitor Protein (‘IAIP‘) product. Feasibility of the use of prothrombin complex concentrate (PCC) as starting material was shown and characterization of the IAIP-product manufactured from PCC was performed.

FVIII/vWF concentrate

Project leader: G.J. Derksen 
A project to develop a second, intermediate pure, FVIII/vWF product besides Aafact in close collaboration with dr. R. Laub from CAF-DCF (Brussels, Belgium) is ongoing. To guarantee virus and prion safety, three reducing steps were developed and implemented in the manufacturing process: SD-treatment, UVC and dry-heat treatment. Large scale manufacturing of this FVIII/vWF product for characterization purposes, virus validation studies and pre-clinical studies is planned. 

 

Improvement of plasma products

Development of new formulations

Project leaders: A. Koenderman and I. Prins
Cetor®, a high-purity C1-inhibitor product and Cinryze™, C1-Inhibitor product manufactured from USA plasma, are used for the treatment of hereditary angioedema (HAE). For both products studies are started to develop a new formulation for subcutaneous administration.

Virus and prion safety of plasma products

Project leaders: H. ter Hart and I. Prins (i.prins@sanquin.nl)
To update the virus and prion safety of several plasma products, the use of new virus removal filters was studied in feasibility studies. It is shown that a new filter can be implemented in several manufacturing processes (a.o. Nanogam®, GammaQuin® and Cofact®) to obtain state-of-the-art virus removal. 

 

Characterization/ new indications

Project leader: A Koenderman
In collaboration with the Dept of Immunopathology, studies on IgG products are ongoing to study dimer formation and polymerization of IgG and its significance in the occurrence of adverse events in patients and the role of glycosylation of IgG for its biological activity.
To improve the use of plasma products characterization studies were started to further characterize Sanquin’s current products Cofact®, Aafact®, Nanogam® and Cetor®/Cinryze™ and the experimental products Holotransferrin and Apotransferrin.

To develop new indications for Cetor® collaborations were started with research groups of the University Medical Center Utrecht and the Radboud University Nijmegen Medical Centre.

Up to now there is no efficacious treatment available for severely affected trauma patients. A human LPS model has been used to mimic the cytokine response of trauma patients and to study a possible role of C1-Inhibitor on the cytokine response. The ’VECTOR Study‘ (In vivo effects of C1-esterase inhibitor on innate immune response during endotoxemia in human) was performed. It was shown that C1-Inhibitor reduces the pro-inflammatory cytokines and increases the anti-inflammatory cytokines studied. New studies are planned for 2011. 

 

Key publication