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Category Archives: Chemistry

Emerging Peptide Technology Spotlight: Molecular Hiving

Posted on August 3, 2018 by

Earlier this year, Neuland began working with a technology called Molecular HivingTM along with Jitsubo Co. (Read the March 2018 press release here).  It’s a patented technique to manufacture peptides…

Posted in Chemistry, Jitsubo, Molecular Hiving, peptide, peptides, Process Engineering | Comments Off on Emerging Peptide Technology Spotlight: Molecular Hiving

API Synthesis Properties Affecting Yield, Delivery Date & Purity

Posted on June 15, 2018 by

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)

Posted on May 19, 2018 by

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)

Pharmaceutical Manufacturing: Comparing Particle Reduction Techniques

Posted on May 4, 2018 by

While there are a number of particle size reduction technologies in use in the pharmaceutical industry today, from our vantage point as an API manufacturer we typically see requests for…

Posted in APIs, Chemistry, micronization, particle size, Process Engineering | Comments Off on Pharmaceutical Manufacturing: Comparing Particle Reduction Techniques

QbD and Evaluating ‘What-If’ Drug Manufacturing Scenarios

Posted on April 2, 2018 by

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

Inside QBD: Chemists & Engineers Collaborate on Quality

Posted on February 24, 2018 by

In a PharmTech webcast, the Neuland team linked up with Dr. San Kiang – Research Professor from the Department of Chemical Engineering at Rutgers University. The objective was a discussion…

Posted in Chemistry, drug discovery, drugs, process chemistry, Process Engineering, QbD, Quality, R&D, Route Design, Route Scouting, scale-up, Synthesis Route | Comments Off on Inside QBD: Chemists & Engineers Collaborate on Quality

Synthetic Route Scouting: Factors to Improve API Manufacturing

Posted on January 7, 2018 by

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

Posted on December 3, 2017 by

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

3 Success Factors for Pharma Regulatory Inspections

Posted on October 28, 2017 by

Current Good Manufacturing Practices (cGMPs) are an essential aspect of compliance, and attention on them by regulators is growing. In today’s global pharma industry, it’s common to have multiple investigators…

Posted in APIs, audit, Capabilities, Chemistry, Contract Manufacturing, CRO/CMO, FDA, Neuland Labs, QA/QC, Quality, regulatory | Comments Off on 3 Success Factors for Pharma Regulatory Inspections

How to Select a Peptide Synthesis Technique

Posted on October 1, 2017 by

Peptides are a complex drug class, and have historically proven challenging from a manufacturing standpoint. They are, however, experiencing a renaissance due to improvements in peptide synthesis, the development of…

Posted in API synthesis, Chemistry, CMC, Contract Manufacturing, method development, peptide, Peptide aggregation, peptides, process chemistry | Comments Off on How to Select a Peptide Synthesis Technique