Cell therapy formulation

Albumedix’s Recombumin®, recombinant albumin products offer a safe solution for optimized cell performance and improved variability control in the manufacture and formulation of cell therapies.

Cell therapy, such as immune cell and stem cell based therapies offer attractive alternative approaches to more widely used treatment options. However, before these can become suitable as effective therapies there are several manufacturing, formulation and handling challenges that need to be overcome. Of these, product heterogeneity is one of the main concerns and can arise during the entire value chain, from upstream culture and cell preservation, to cell therapy administration. Consequently, pharmaceutical companies are striving to understand and control cell viability and variability.

Traditionally, serum and human serum albumin (HSA) have been found to be useful stabilizers in cell culture media and preservation media. However, due to regulatory concerns over blood-borne contaminants (mycoplasma, viruses, and prions), potential issues with reliability of supply and the performance variability of HSA and undefined serum, there is an increased demand for a more defined animal origin-free recombinant alternative. Given the superior safety profile of Recombumin® and demonstrated drug stabilization performance, it provides an ideal, low-risk stabilizer for cell culture and formulation.

Both in upstream and downstream cell suspensions Recombumin® serves multiple purposes:

  • Nutrient carrier to  cells ensuring optimal growth conditions
  • Stabilization of cell membrane and co-formulated proteins
  • Radical scavenger against free radicals
  • Viscosity modulator in culture media
  • Buffering for media toxins

Coupled with the unrivalled technical expertise of Albumedix, these attributes give cell therapy and stem cell media developers the possibility to control batch-to-batch variations through higher tolerance to stress, while improving cell viability and morphology.

Recombumin® is provided by Albumedix, a trusted and reliable technology supplier, which has the scientific, technical and regulatory expertise needed to support you in developing your cell therapy.

Albumedix’s Recombumin® products have been validated by our partners across several therapeutic indications and cell types and are currently being used globally in the clinical development of cell therapies.

 

 

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