Media development can be considered an art of itself. Besides medium com-

position, a major requirement for their use is sterility, meaning the absence of

microorganisms (bacteria, yeasts, fungi), which is ensured mainly by sterile filtra-

tion. Moreover, to allow optimal cell growth and virus production, media should be

buffered to provide a physiological pH value. Often a bicarbonate buffer system is

applied, where sodium bicarbonate (NaHCO3) is added to the medium, while

carbon dioxide (CO2) can be provided via the inlet air of the incubator or cultivation

vessels. Another key requirement of the medium is the adequate supply of nutrients,

such as glucose or glutamine, which are necessary for cell survival and prolifera-

tion. However, each cell type, along with the desired product, has specific com-

ponent and concentration requirements. Hence, the medium formulation needs to be

adjusted and optimized very carefully. Moreover, care should be taken during

media development to restrict the accumulation of unwanted, metabolic by-products

including ammonium and lactate. Therefore, design of experiment approaches are

frequently used to maximize the specific growth rate and virus yields. As media

TABLE 5.3

Categories of media used in animal cell culture

Abbrev.

Definition

Serum 1 Hydrolysate 2 Human-derived

components 3

Animal-derived

components 4

Peptides 5

SCM

Serum-

containing

Yes

Yes

Yes

Yes

Yes

SFM

Serum-free

No

Yes

Yes

Yes

Yes

AFM

Animal

component-

free

No

Yes

Yes

No

Yes

XFM

Xeno-free

No

Yes

Yes/No 6

No

Yes

PFM

Protein-free

No

No 7

No

No

Yes 8

CDM

Chemically

defined

No

No

Yes

Yes

Yes

Notes

1 Serum: mainly fetal bovine or fetal calf serum (FBS or FCS) from traceable sources without the risk

of prion contamination, batch-to-batch variations, human or equine sera may also be used.

2 Hydrolysate from mechanical, chemical or enzymatic treatment of soy, yeast, or animal extracts,

batch to batch variations, might still contain proteins.

3 Typically recombinant human serum albumin

4 Enzymes and/or growth factors that are not produced recombinant.

5 Protein hydrolysates.

6 Depends e.g., on cell line origin; human components may be required for a human cell line.

7 May contain hydrolysates only in special cases, then hydrolysates should be protein-free.

8 Includes amino acids or di-/tripeptides, but not polypeptides or proteins [ 36].

Yes: is allowed to be part of the medium, No: is not allowed; some suppliers differ in definition of

composition, especially regarding peptides.

96

Bioprocessing of Viral Vaccines