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Category Archives: process chemistry

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…

Posted in FDA, generic, method development, process chemistry, QA/QC, Quality, synthesis | Tagged , , , , , | Comments Off on How the Valsartan Contamination Happened: Its Context & Implications

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

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

Drug API & Peptide Trends: 2019

With the global population continuing to both increase and age, pharma industry growth is likely to continue. While facing pricing hurdles in well-established mature markets, the emerging drug markets (China,…

Posted in API synthesis, APIs, CDMO, Contract Manufacturing, CRO/CMO, generic, Neuland Labs, peptide, peptides, process chemistry, Process Engineering, QA/QC, QbD, regulatory, Route Design, Route Scouting | Comments Off on Drug API & Peptide Trends: 2019

Neuland Patent Spotlight: Paliperidone Palmitate & Antipsychotics

The use of anti-psychotic drugs to treat conditions such as schizophrenia and bipolar disorder is on the rise and estimated to reach $18.5 billion by 2022. It is a market…

Posted in Chemistry, DMF, generic, IP, Neuland Labs, Patent, process chemistry | Comments Off on Neuland Patent Spotlight: Paliperidone Palmitate & Antipsychotics

Case Studies from Neuland’s Process Engineering Lab

In our PE Lab, a team of 27 highly specialized engineers integrates the key attributes of QbD process understanding, process control, and continuous improvement with advanced equipment, Design of Experiments…

Posted in analytical science, API synthesis, APIs, Capabilities, Chemistry, Design of Experiment, method development, micronization, Neuland Labs, PAT, process chemistry, Process Engineering, QbD, Quality, Route Scouting, Synthesis Route | Comments Off on Case Studies from Neuland’s Process Engineering Lab

API Synthesis Properties Affecting Yield, Delivery Date & Purity

Properties which can affect an API’s yield, delivery date and purity include: Type of Synthesis Propinquity Complexity of Structure Cost Efficient Synthesis Carryover of impurities into drug substance Minimum isolation…

Posted in API synthesis, APIs, Chemistry, CMC, method development, Neuland Labs, process chemistry, Process Engineering, Route Design, Route Scouting, synthesis, Synthesis Route | Comments Off on API Synthesis Properties Affecting Yield, Delivery Date & Purity

QbD and Evaluating ‘What-If’ Drug Manufacturing Scenarios

In recent posts on the topic of Quality by Design and drug manufacturing, we referenced (here, here and here) the importance of being able to reduce unanticipated challenges by developing…

Posted in API synthesis, APIs, Chemistry, CMC, Contract Manufacturing, CQA, critical reaction parameters, Design of Experiment, FDA, Impurity profile, Neuland Labs, process chemistry, QbD, Quality | Comments Off on QbD and Evaluating ‘What-If’ Drug Manufacturing Scenarios