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OUTSOURCED PHARMA

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The External Partners Delivering The Components Of RNA Therapies
During my discussion with two executive members of the relatively new Society For RNA Therapeutics (SRT) they mentioned external partners and...

Catalent Says It's Not Our Facility; It Belongs To Novo Nordisk
The FDA informed us again in April that the Bloomington, Indiana, facilities owned by Catalent until sold to Novo Nordisk in December 2024, has...

Let's Stop Treating Allogeneic Cell Therapy As One Thing
Allogeneic cell therapy is often discussed as though it were a single modality moving along a single development path. That framing is...

Top 5 Challenges In Antibody-Oligonucleotide Manufacturing
Antibody-oligonucleotide conjugates (AOCs) combine the targeting precision of antibodies with the gene-modulating power of oligonucleotides,...

Did You Vote To Give Your IP Away?
A vote for now-President Joe Biden was a vote to give your IP away. Feigned surprise at Biden’s agreement with the World Trade Organization...

Did The U.S. Government Just Hijack A CDMO?
Did the U.S. government just seize a private CDMO’s operations? There are serious, extenuating circumstances no doubt, but we need a deeper...

FDA Inspections: Are Changes On The Horizon?
By Kalah Auchincloss, SVP & deputy general counsel, Greenleaf Health, Inc. Almost exactly one year ago, in March 2020, the U.S. FDA announced...

Jubilant HollisterStier Signs Manufacturing Agreement With Eli Lilly For COVID-19 Therapeutic Bamlanivimab
Jubilant Life Sciences Ltd (“Jubilant”), an integrated global Pharmaceuticals and Life Sciences Company, recently announced that its...

Baxter BioPharma Solutions And Moderna Announce Agreement For Fill/Finish Manufacturing Of Moderna COVID-19 Vaccine In USA
Agreement to perform fill/finish services for approximately 60–90 million doses in the U.S. this year Manufacturing will take place at Baxter...

11 Critical Steps To Manage Solvents During API Manufacturing
Many organic solvents are used during the manufacturing of active pharmaceutical ingredients (APIs) and associated intermediates. Solvents may...