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Author Archives: Saharsh Davuluri

How the Valsartan Contamination Happened: Its Context & Implications

Last year’s valsartan contamination and recall brought some surprising chemical synthesis issues to light in the pharma industry. While the reactions used in generic valsartan production are known to be…

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Complex Synthesis in Action: Achieving a Commercial-Scale 16 AA Peptide

Peptide process development projects have increased in the last few years. Judging by our blog readership and social interactions, interest in peptide drugs is continuing to grow by leaps and…

Posted in API synthesis, APIs, Chemistry, Contract Manufacturing, peptide, peptides, scale-up, Uncategorized | Tagged , , | Comments Off on Complex Synthesis in Action: Achieving a Commercial-Scale 16 AA Peptide

Alzheimer’s and Brain Awareness Month

June is Alzheimer’s and Brain Awareness Month. Alzheimer’s Disease (AD) is a heartbreaking and tragic condition affecting millions of families worldwide. This month, we highlight how health and pharma intersect….

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A Guide to Sourcing Pharmaceutical Peptide APIs

Rise of the Peptide Era                                                                                                                                                       Peptide synthesis has a long pharmaceutical history, stretching back to the early 1900s – and then followed by a lengthy period of dormancy….

Posted in API synthesis, APIs, Capabilities, Chemistry, chromatography, CMC, Contract Manufacturing, CRO/CMO, Fmoc, generic, HPLC, Jitsubo, Molecular Hiving, Neuland Labs, peptide, Peptide aggregation, peptides, process chemistry, Process Engineering, synthesis, Synthesis Route, TIDES | Tagged , | Comments Off on A Guide to Sourcing Pharmaceutical Peptide APIs

Deuterated Drugs Reach Two-Year Anniversary

We’ve reached the two year anniversary of the first FDA approval of a deuterated molecule (April 2017, Teva’s Astedo – a deuterated version of tetrabenazine for the treatment of Huntington’s…

Posted in APIs, Chemistry, CMC, Contract Manufacturing, deuterated molecule, deuteration, deuterium exchange, method development, Neuland Labs, process chemistry | Tagged , , , | Comments Off on Deuterated Drugs Reach Two-Year Anniversary

Inside Sugammadex: Overcoming Impurities in Commercial API Manufacturing

The first in the class of drugs known as selective relaxant binding agents (SRBA), Sugammadex sodium is used to reverse anesthesia. Via 1:1 binding of rocuronium or vecuronium, it rapidly…

Posted in Chemistry, CMC, Contract Manufacturing, generic, Impurity profile, process chemistry, Process Engineering, Route Design, Synthesis Route | Tagged , | Comments Off on Inside Sugammadex: Overcoming Impurities in Commercial API Manufacturing

The Unblockbuster – Speeding Cures with Specialty Drugs

For years, industry soothsayers have suggested the imminent demise of blockbuster drugs was upon us (here’s one from 2009 – Goodbye blockbuster medicines; hello new pharmaceutical business models). But two…

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Pharma Tech Transfer Gets Collaborative

Drug manufacturing technology transfer is one of the most complicated and demanding processes in the drug company-contract development organization relationship. There is one overriding deliverable that must go right –…

Posted in API synthesis, Chemistry, CMC, Contract Manufacturing, method development, process chemistry, Process Engineering, R&D, scale-up, technology transfer | Tagged , , | Comments Off on Pharma Tech Transfer Gets Collaborative

TIDES TV: The Past, Present & Future of Peptides

Dr. Mike Anwer – Neuland’s President of Peptide Synthesis – recently sat down with Andy Busrt of TIDES TV to discuss the peptide drug market. Peptides – From Insulin to…

Posted in APIs, AsiaTIDES, Contract Manufacturing, Neuland Labs, peptide, peptides, TIDES | Tagged , , | Comments Off on TIDES TV: The Past, Present & Future of Peptides

Inside Neuland Technology: Bosentan Monohydrate

Pulmonary arterial hypertension (PAH) is a rare disease affecting 1-2 people per million in the U.S. and Europe. The orphan drug Bosentan, a dual endothelin receptor antagonist, is used in…

Posted in API synthesis, APIs, Capabilities, Chemistry, Contract Manufacturing, drugs, generic, method development, Neuland Labs, Orphan drug | Tagged , , | Comments Off on Inside Neuland Technology: Bosentan Monohydrate