Replies to post #2029 on GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Good post. Ease of scale-up will always be a major benefit—perhaps the main benefit—of transgenic production for most protein drugs. For any drug with a novel MoA, gauging the commercial demand when a product is not yet in human trials will forever involve huge amounts of guesswork.

Take Merrimack’s MM-093, for instance. Will it be a niche drug for third- and fourth-line RA that does $100M a year in sales… or will it be a bona fide blockbuster that sells in the billions? Who knows.

For Merrimack, it may have been a stroke of luck that AFP does not express in cell culture, leaving no realistic production choice other than GTC.

[dewophile]

good pints, but I'm not sure how the scaleability issue would affect a smaller biotech that outsources manufacturing. The up front commmitment is gone in return for a premium on the manufacturing side. if production exceeds demand, is the company liable for the balance, or do they purchase on a per unit basis? I'm just not sure how these agreements are structured.
the bigger pharmas are investing so much in cell culture that it seems to me they need multiple runaway hits to exceed capacity (which with 200 mabs could happen, i just don't see it happening soon)
there was an interesting article on this subject in nature or science a while back, and if I recall the enbrel example was highlighted