Newsletter | November 22, 2023

11.22.23 -- Preformulation Of Excipients In Biologics Development


Preformulation Of Excipients In Biologics Development

Most of the instability problems of a drug product come from excipients; in particular, they come from impurities in excipients. Those issues are best cleaned up in the preformulation period to determine excipient compatibility.

Here’s Why Outsourcing To CDMOs Doubled In 13 Years

It might surprise no one that BioPlan Associates' 20th annual survey on manufacturing found an increased dependence on contract manufacturing. The sheer rate at which demand has grown, however, is stunning, and the survey found CDMO capacity is only now starting to catch up with supply.

Is ‘Human Error’ The Cause Or The Outcome Of GMP Deviations?

Painting mistakes with the broad human error brush ignores the underlying causes, which can be complex. Amnon Eylath, a veteran GMP consultant, presents a case study that illustrates why he encourages companies to adopt robust processes for uncovering true root causes and reducing deviations.


STADA & Alvotech Receive Positive CHMP Opinion For Europe’s First Ustekinumab Biosimilar To Stelara

Alvotech & JAMP Pharma Announce Receipt Of Marketing Authorization For Jamteki (AVT04), The First Biosimilar Of Stelara (ustekinumab)

Plantform & Swiftpharma Target Blockbuster Cancer Drug With New Contract Mfg Agreement For Plant-Made Biosimilars

Report: Hundreds Of Thousands Of Patients Across Europe Miss Out On Advanced Medicines Due To Low Biosimilar Adoption


Set Of 96-Well Plates Prefilled With Six Different HIC Resins For HTPD


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