Peak serum: implications of serum supply for cell therapy manufacturing

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From: Regenerative Medicine(Vol. 7, Issue 1)
Publisher: Future Medicine Ltd.
Document Type: Report
Length: 3,692 words
Lexile Measure: 1510L

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Author(s): David A Brindley [**] 8 , Natasha L Davie 1 2 4 5 , Emily J Culme-Seymour 4 6 , Chris Mason 1 4 , David W Smith 7 , Jon A Rowley 7

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biomanufacturing; bioprocessing; cell therapy; commercialization; fetal bovine serum; manufacturing; process optimization; serum

The cell therapy industry (CTI) is emerging as a distinct and competitive component of global healthcare, creating value for investors and providing life-changing therapies to patients [1,2] . Industry growth has necessitated an increased focus on large-scale manufacturing strategies to meet future demands [3,4] . One major challenge is the limited availability of some crucial raw materials used in cell therapy manufacturing - including bovine serum. Without a sustainable supply or viable alternatives to these components, the commercial-scale production of cell therapies will be impossible, halting the momentum of the industry. We propose that solutions to these challenges are achievable, and can be expedited by industry-wide collaboration.

Bovine serum is currently used in the majority of cell therapy manufacturing processes. Current stocks and production rates of serum suitable for GMP manufacture may only be sufficient to support the production of one blockbuster cell therapy. Limitations in the availability of bovine serum thus act as a major cost driver and significant barrier to the commercial success of the industry as a whole. Thus, without an increase in serum production, or at least a significant increase in the development and implementation of serum-free production strategies, the growth and sustainability of the CTI will be severely constrained.

Uses of serum

Serum has been widely used in cell culture for over a century [5] . Whilst its beneficial impact on cell culturing is universally agreed, its precise mechanisms of action are still not totally known. It serves various functions necessary for effective cell culture, including the provision of important growth and attachment factors, protease inhibitors and protection against shear stress in agitated culture [6] . Without the addition of serum, proteolytic activity within cell culture would ensue, resulting in reduced cell growth and proliferation [7] .

There are several potential sources of serum, each with different compositions and characteristics. The most commonly used is fetal bovine serum (FBS) due to its strong growth-promoting capacity and relatively low immunoglobulin levels. However, as multiple calf fetuses are required to make a single liter of FBS, it is also the most expensive type of serum. Cheaper alternatives include new-born, calf, adult, donor calf or donor adult cattle serum [8] . It is also possible to use serum sourced from other animals, including horses and sheep. In general, serum sourced from older animals contains more antibodies and has a greater protein and lipid content.

The type of serum used can have huge implications in processing and cell characterization. Since 'the product is the process'â, changes in the type of serum can alter fundamental properties of a cell type, including proliferation kinetics and specific phenotypical characteristics such as cell potency and identity. Furthermore, within the same 'type'â of serum there is significant variability from batch to batch, thus in order to ascertain which serum is...

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Gale Document Number: GALE|A274932493