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Category Archives: synthesis

The Impact of Impurities on the Pharmaceutical Industry

A significant paradigm shift is underway in the regulatory environment for impurities in pharmaceutical products. Recent incidents involving genotoxic impurities (GTIs) are driving tighter restrictions and guidelines, as well as…

Posted in API synthesis, APIs, Chemistry, drugs, genotoxic impurities, Impurity profile, QA/QC, Quality, Route Design, Route Scouting, synthesis, Synthesis Route, Valsartan | Comments Off on The Impact of Impurities on the Pharmaceutical Industry

Looking for an API Supplier? 5 Things to Consider (Updated)

Seven years ago – in March of 2013 – we published a blog post on 5 Things to Consider When Looking for an API Supplier. Because seven human years equals…

Posted in API synthesis, APIs, Chemistry, CMC, Contract Manufacturing, drugs, FDA, Neuland Labs, process chemistry, Process Engineering, Project Management, Quality, R&D, regulatory, supply chain, synthesis | Tagged , , | Comments Off on Looking for an API Supplier? 5 Things to Consider (Updated)

Solving the Insoluble

Soluble drug APIs are now the exception, not the rule. An article at PharmTech by Felicity Thomas (Looking Beyond the Solubility Horizon) caught my eye recently as it discussed a…

Posted in APIs, Capabilities, Chemistry, Contract Manufacturing, CRO/CMO, Pharm Tech, Pharmaceutical Technology, R&D, Route Design, Route Scouting, synthesis | Tagged , , , , | Comments Off on Solving the Insoluble

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

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

NCEs Versus Generics – Adjusting Project Tactics & Objectives to Maximize Success

Since generic drugs are – on average – 20 to 90% cheaper than innovator drugs (or NCEs), the market for generics has grown considerably in recent years as a means…

Posted in Contract Manufacturing, drugs, generic, NCE, process chemistry, small molecule, synthesis, Synthesis Route | Comments Off on NCEs Versus Generics – Adjusting Project Tactics & Objectives to Maximize Success

5 Common Challenges Scaling Up an API

While linear drug scale-up sounds great on paper, the reality is usually much different. In fact, scaling up an API can be challenging even under the best circumstances. In fact,…

Posted in APIs, CMC, Contract Manufacturing, critical reaction parameters, CRO/CMO, method development, Neuland Labs, particle size, Route Design, Route Scouting, scale-up, synthesis | Comments Off on 5 Common Challenges Scaling Up an API

Unveiling Neuland’s Process Engineering Lab: Tightening our Focus on QbD

Neuland has recently welcomed the addition of a new, dedicated Process Engineering Lab to its R&D Center. The lab opened in March, and supports operations and safety studies via a…

Posted in Chemistry, CMC, Contract Manufacturing, drugs, method development, Neuland Labs, process chemistry, Process Engineering, QbD, Quality, Quality Agreement, R&D, Route Design, scale-up, synthesis | Comments Off on Unveiling Neuland’s Process Engineering Lab: Tightening our Focus on QbD

Peptide Therapeutics infographic

 

Posted in APIs, Fmoc, Neuland Labs, peptide, peptides, process chemistry, scale-up, synthesis | Comments Off on Peptide Therapeutics infographic