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Category Archives: method development

How CMO Expertise Can Solve Key Challenges in Late Phase Drug API Projects

Stating the obvious here, but drug development is a protracted, expensive and risky process. From the lab bench to pharmacy shelves, bringing a new drug to market often stretches 10+…

Posted in APIs, Capabilities, Chemistry, CMC, Contract Manufacturing, CRO/CMO, drugs, method development, Neuland Labs, outsourcing, process chemistry, Process Engineering, scale-up | Tagged , , , , | Comments Off on How CMO Expertise Can Solve Key Challenges in Late Phase Drug API Projects

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

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

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

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

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

Neuland & Generic Drug Substances (GDS)

From the day Neuland was established in 1984, our core business and operational expertise has been the manufacturing of Generic Drug Substances. More specifically, delivering niche, highly-specialized and complex synthetic…

Posted in API synthesis, APIs, Chemistry, Contract Manufacturing, drugs, generic, method development | Comments Off on Neuland & Generic Drug Substances (GDS)

Synthetic Route Scouting: Factors to Improve API Manufacturing

Synthetic route selection is a crucial element in API manufacturing. While the requirements of the synthetic process of a drug will naturally evolve during its life cycle, scouting alternate routes…

Posted in API synthesis, APIs, atom economy, Benign-by-Design, Chemistry, Contract Manufacturing, CRO/CMO, green chemistry, method development, Neuland Labs, outsourcing, process chemistry, Process Engineering, Route Design, Route Scouting, scale-up, Synthesis Route | Comments Off on Synthetic Route Scouting: Factors to Improve API Manufacturing

Speed-to-Market: Streamlining Pharma API Production

In both the generic and innovator pharmaceutical API production sectors, time-to-market is a critical factor. How critical? A one-day delay in reaching the market could mean the loss of $1…

Posted in API synthesis, APIs, Capabilities, Chemistry, Contract Manufacturing, CRO/CMO, drugs, method development, Neuland Labs, outsourcing, Paragraph IV, process chemistry, Process Engineering, speed-to-market, time-to-market | Comments Off on Speed-to-Market: Streamlining Pharma API Production