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European Biopharmaceutical Review

Recombinant Human Albumin




Stem cell and gene therapies are some of the most cuttingedge and sophisticated therapeutic developments. They offer attractive alternative approaches to widely used treatments in areas such as multiple sclerosis, metabolic diseases, cardiovascular disease, and liver disease. The field is burgeoning, but developers still face challenges, some of which can be addressed by using recombinant human albumin (rHA).

As a long-established ingredient of cell culture media, albumin is well recognised for its ability to facilitate growth of many cell types. With the industry expanding the use of high-quality, fully recombinant, cGMP excipients in cryopreservation and formulation of stem cell therapies, the manufacturing, formulation, and handling challenges associated with the development of cell therapies must be explored. The authors will also assess how the use of rHA in the culture, expansion/differentiation, cryopreservation, and formulation of stem cells compares with alternative approaches such as albumin(s) derived from human (human serum albumin [HSA]) or bovine (FBS) serums.

Overcoming Cell Therapy Challenges

Stem cell therapy, a type of regenerative medicine, promotes the repair response of diseased, dysfunctional, or injured tissue using stem cells or their derivatives. Cell therapy can face many challenges in regard to reproducibly optimising, controlling and scaling cell isolation, expansion, transformation, cryopreservation, and final formulation. From a processing angle, cell viability, growth rate, and reproducibility can all present serious issues for manufacturers. These can be affected by aggregation of the cells, shear stresses, and contact of the cells with surfaces. Additionally, the maintenance of cell identity and multipotency and the assurance of cell survival during transformation can also lead to setbacks during development. Regarding formulation, quality control of final products, storage and transportation, apoptosis, loss of identity, multipotency, and safety all present considerable challenges. The cost of goods to manufacture a cell therapy can also have an enormous impact on the long-term viability and sustainability of the therapy as a commercialised product.



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Dr Phil Morton is the Chief Technology Officer heading up Albumedix’s Technology Group. He has over 20 years’ experience in the biopharmaceutical industry within process and product development both in R&D and manufacturing environments. His experience ranges from developing and transferring purification processes to formulation development and characterisation of these processes and products. Phil holds a PhD in Biochemical Engineering from Birmingham University, UK, and followed this with post-doctoral studies at Cambridge University, UK.

Dr Daniel Shelly is Director of Business Development at Albumedix, responsible for business development and outlicensing of Albumedix’s core technologies and recombinant albumin products for manufacture, stabilisation, and formulation of small molecule, peptide, protein, viral, and cell therapeutics. Daniel spent 10 years in cell culture, vaccine and gene therapy, clinical development and manufacturing. He has authored several peer reviewed articles and book chapters and is an adjunct professor in the University of Cincinnati Clinical Master’s program teaching Biologics Discovery and Biotechnology Management, US. He has degrees from Lehigh University (BA), US, The College of William and Mary (MA), US, Florida State University (PhD), US, and the University of Cincinnati (MBA), US. He did his postdoc at the University of Cincinnati College of Medicine, winning the APS Physiological Genomics Fellowship and an NIH NRSA.
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Dr Phil Morton
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Dr Daniel Shelly
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