Whether you are making a biologic or a biosimilar, the manufacturing process (for the most part) is the same.
You're going to have cell culture or fermentation in either as a batch or continuous process.
You're going to have a recovery/purification train of 3 or more steps where you're purifying the drug and getting rid of unwanted biochemicals.
You're going to freeze that into huge ice cube and ship it to your fill/finish facility where they're going to thaw it and dispense the drug product into vials.
What biologic you make and how hard it is to make was decided by your Process Development group years ago when they were poking the DNA into cells, growing them and picking the "best" one. (This is a big-time simplification, the wonkish version of expression system selection, cell line development, cell line engineering, platform development, clone selection, process characterization/validation... etc.)
If you inoculated a bioreactor with the cells that were transfected with the anti-CD20 gene, you're going to get rituximab.
It goes without saying that you must follow the recipe/manufacturing formula for the respective cell lines, which will contain minor differences across upstream and downstream.
The crux of biologics manufacturing is cell line development and what makes biologics manufacturing hard was doing the cell line development right.
If you inoculated your bioreactor with cells that were transfected with the anti-CD20 gene by a Dr. Reddy's scientist, you're going to get the biosimilar: Reditux®.
What no one knew a decade ago (2003) was whether or not the Dr. Reddy's cell line could produce a molecule identical to the IDEC molecule. And even if they could, would this molecule be as safe and as effective as the FDA-approved IDEC molecule?
Is pouring the HCCF down chrom columns and hard? Broadly speaking, I'd say there's no shortage of people who can execute a large-scale biologics manufacturing process.
Is cell line engineering, platform development, clone selection tough...etc hard? The grunt work can be done by entry-level scientists/engineers, but you probably want Ph.Ds leading the team to ask the right questions and to cast aside the technical road blocks.
Can Amgen take market share from Roche, Lilly, Abbvie and Janssen? Sure. Amgen has the right people, the resources and leadership.
Is making biologics so difficult to make that no one else can do it? I don't think so. There's already generic versions of Aranesp, Neulasta and Neupogen in ex-US markets.
You're going to freeze that into huge ice cube and ship it to your fill/finish facility where they're going to thaw it and dispense the drug product into vials.
What biologic you make and how hard it is to make was decided by your Process Development group years ago when they were poking the DNA into cells, growing them and picking the "best" one. (This is a big-time simplification, the wonkish version of expression system selection, cell line development, cell line engineering, platform development, clone selection, process characterization/validation... etc.)
What decides whether you're making bevacizumab or rituximab?
If you inoculated a bioreactor with the cells that were transfected with the anti-VEGF gene, you're going to get bevacizumab.If you inoculated a bioreactor with the cells that were transfected with the anti-CD20 gene, you're going to get rituximab.
It goes without saying that you must follow the recipe/manufacturing formula for the respective cell lines, which will contain minor differences across upstream and downstream.
The crux of biologics manufacturing is cell line development and what makes biologics manufacturing hard was doing the cell line development right.
What decides whether you're making Rituxan® or Reditux®?
If you inoculated your bioreactor with cells that were transfected with the anti-CD20 gene by an IDEC scientist, you're going to get the biologic: Rituxan®.If you inoculated your bioreactor with cells that were transfected with the anti-CD20 gene by a Dr. Reddy's scientist, you're going to get the biosimilar: Reditux®.
What no one knew a decade ago (2003) was whether or not the Dr. Reddy's cell line could produce a molecule identical to the IDEC molecule. And even if they could, would this molecule be as safe and as effective as the FDA-approved IDEC molecule?
Is Making Biologics Hard?
This is a very broad question. Is putting cells into a bioreactor and watching them grow hard? ...because that's how the active pharmaceutical ingredients get made.Is pouring the HCCF down chrom columns and hard? Broadly speaking, I'd say there's no shortage of people who can execute a large-scale biologics manufacturing process.
Is cell line engineering, platform development, clone selection tough...etc hard? The grunt work can be done by entry-level scientists/engineers, but you probably want Ph.Ds leading the team to ask the right questions and to cast aside the technical road blocks.
Can Amgen take market share from Roche, Lilly, Abbvie and Janssen? Sure. Amgen has the right people, the resources and leadership.
Is making biologics so difficult to make that no one else can do it? I don't think so. There's already generic versions of Aranesp, Neulasta and Neupogen in ex-US markets.
2 comments:
We STILL don't know if Reditux will be approved by the FDA. When Reditux or another biosimilar kills someone, who will want to buy biosimilars anymore?
All drugs carry risk, the question is whether or not that risk exceeds the benefit.
Take Abbott's Humira: 0.19% of the adverse events resulted in death.
0.19% is a small number, but that represents 906 reported adverse events.
http://drugcite.com/?q=humira
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