Tag: <span>process differences</span>

From the Publisher: Biosimilars, Biogenerics, or Follow-On Biologics to Licensed Materials

There are many examples of efforts to make biosimilar products, such as every time a product is taken to a larger
scale, and when an established product is transferred to another facility, including a contract manufacturing site.
While most of these examples have resulted in products which were indistinguishable for all practical purposes,
others revealed troubling differences during product characterization or clinical administration…

Read MoreFrom the Publisher: Biosimilars, Biogenerics, or Follow-On Biologics to Licensed Materials

Biologics Production

biogenerics biologics biopharmaceuticals biosimilars biotech industry follow-on biologics patent expirations process differences regulatory records

From the Editor-in-Chief: “Therapeutic Glyco-Proteins Produced by Living Organisms” or “Drugs”?

“But why are they calling these products ‘drugs?’” I asked at the recent CMC Strategy meeting that CaSSS hosted in Gaithersburg. “Well it’s because they aren’t vaccines or blood products” said an old friend, who is an authority in the field. “But,” I said, “we’re really talking about therapeutic glyco-proteins produced by living organisms.” And just to make sure I was remembering things correctly, I searched Google and reviewed the definitions for a “biologic” and “biological” in several of the top technical references. Truly, a biologic or biological is a substance produced by a living organism, which would include glyco-proteins, non-glycosylated proteins, enzymes, viruses, and broken up proteins which could be used as poly-peptides or simple antigens…

Read MoreFrom the Editor-in-Chief: “Therapeutic Glyco-Proteins Produced by Living Organisms” or “Drugs”?

Biologics Production

biopharmaceuticals biotech industry biotherapeutics cber cder drug FDA generic biopharmaceuticals polypeptides process differences small-molecule drugs