Frequently Asked Questions

  1. Why should a fully human cell line be used as an expression system for biopharmaceutical protein production?
  2. Why should Anthrocell's human cell line be used?
  3. What advantages does Anthrocell's technology offer for protein production?
  4. What distinct advantage does Anthrocell's technology offer for antibody production in particular?
  5. What benefits may be gained by using Anthrocell's technology for the production of biosimilars (generic biological drugs)?
  6. Is Anthrocell's cell line stable?
  7. Is Anthrocell's cell line safe?
  8. How does Anthrocell's product yield compare to the industry standard?

1. Why should a fully human cell line be used as an expression system for biopharmaceutical protein production?

The use of bacterial, yeast, or mammalian (non-human) host cells as an expression system for protein production results in products with different glycosylation and other structural properties, pharmacological activity (including immunogenicity) and toxicity, than would be the case were the same protein produced by a fully human expression system. Thus, an expression system based on a fully human cell line is far more attuned to the production of biopharmaceutical proteins for high efficacy use in human patients than the nearest competing animal cell line, with relatively minimal side-effects. Being fully human in nature, the protein does exactly what it is supposed to do in the human body, unlike those produced by non-human expression cells. One implication of this is that for a particular biopharmaceutical protein, a lower dose of a protein produced by a fully human cell line would be required than that of the equivalent protein produced by a non-human cell line.

In addition, many biopharmaceutical protein manufacturers are beginning to incorporate fully human cell lines into their production capability. Remaining competitive in this sphere necessitates consideration of a fully human cell line by all vendors.

2. Why should Anthrocell's human cell line be used?

Anthrocell's human cell line has technological superiority being universal, robust, of a high quality and utility, and producing high yields. It is also commercially superior being free of licence. Unlike much of the competition, Anthrocell's human cell line comes unencumbered by marketing or distribution rights, thereby opening key strategic options for the licensees that are not available with some of the competing cell lines. This makes Anthrocell's offer much more appealing for many emerging biotech companies as it leaves their exit options open.

3. What advantages does Anthrocell's technology offer for protein production?

Compared to that of our nearest competitors, Anthrocell's technology:

  • Requires a shorter R & D cycle for obtaining stably expressing clones.
  • Generates higher yields of lead clone to start with.
  • Avoids the perfusion system of manufacturing with its disadvantages.

4. What distinct advantage does Anthrocell's technology offer for antibody production in particular?

Anthrocell's human cell line is lymphocyte derived, offering the following distinct advantages in the production of antibodies:

  • With the emerging importance of tissue-specific modifications, the human lymphocyte origin of Anthrocell's cell line makes it the natural choice for antibody production, resulting in a high quality product.
  • Anthrocell's human cell line allows the expression of other subtypes of mAbs besides IgG, particularly IgM which is emerging as an antibody of choice for some applications.

5. What benefits may be gained by using Anthrocell's technology for the production of biobetters (generic biological drugs)?

A biosimilar, in reality, needs to be "bio-identical" for maximal efficacy and minimal toxicity and other side-effects. Anthrocell's proprietary expression system enables the production of fully human biobetter proteins with a fully human expression system, thus maximising the up-side while minimising the down-side.

While this may be considered a significant process change, we believe it is unlikely that a complete set of new trials would be required. In Europe, where the regulatory discussions in this area are quite advanced relative to the US, it is becoming clear that the requirement will be for much smaller “similarity” trials. In emerging markets (e.g. China has made a large commitment to building up a CMO capability) the introduction of new expression systems for off-patent drugs would likely face much lower barriers.

6. Is Anthrocell's cell line stable?

Anthrocell's cells have been passaged in continous culture for over six months without loss of mAb production, evidencing generational stability.

7. Is Anthrocell's cell line safe?

The cell line is virus free.

8. How does Anthrocell's product yield compare to the industry standard?

Anthrocell's product yield from fed-batch cultures is the highest in the industry for the same culture duration.

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