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Category Archives: method development

How to Select a Peptide Synthesis Technique

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

Leveraging QbD for API Scale Up

Earlier this month we wrote a piece on the Five Challenges Scaling Up an Active Pharmaceutical Ingredient (API). In the post’s conclusion, we discussed the role of QbD in aiding…

Posted in API synthesis, APIs, Design of Experiment, method development, Neuland Labs, QbD, Quality, regulatory, Uncategorized | Comments Off on Leveraging QbD for API Scale Up

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

Inside Look: The Role of the IPR Department

Intellectual Property Rights and its Importance in Research, Business & Industry We wrote a post on the patent cliff issue back in 2015. The patent cliff has served to further…

Posted in agreement, Contract Manufacturing, IP, method development, Neuland Labs, Patent, technology transfer | Comments Off on Inside Look: The Role of the IPR Department

Defining the Contract Pharma Provider Relationship

I read an article at Pharmaceutical Manufacturing earlier this year (Inking the Deal: Mastering the art of lasting outsourcing relationships in the pharmaceutical industry) on the nature of contract pharma…

Posted in agreement, APIs, Contract Manufacturing, drugs, method development, Neuland Labs, outsourcing, process chemistry, Process Engineering, Project Management | Comments Off on Defining the Contract Pharma Provider Relationship

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

How Process Engineering Techniques Result in Cost-Effective Products

With the cost pressures of today’s competitive market, active pharma ingredient (API) sales profit margins are continuously falling. As a result, pharmaceutical manufacturers find themselves under pressure to cut production…

Posted in Chemistry, Contract Manufacturing, method development, Neuland Labs, PAT, process chemistry, Process Engineering, Project Management | Comments Off on How Process Engineering Techniques Result in Cost-Effective Products

API Manufacture of Deuterated Molecules

Deuterated compounds – in which a drug molecule’s carbon-hydrogen bond is replaced with a carbon deuterium bond to extend the drug’s half-life – continue to show promise in potentially boosting the…

Posted in API synthesis, APIs, CMC, Contract Manufacturing, CRO/CMO, deuterated molecule, deuteration, deuterium exchange, method development | Comments Off on API Manufacture of Deuterated Molecules

Emerging Trends in Analytical R&D

In the pharmaceutical discovery space, many promising analytical trends have emerged and are now on the rise – and they will see increasing use in drug discovery in coming years….

Posted in analytical science, APIs, Capabilities, Chemistry, chromatography, drug discovery, HPLC, Impurity profile, method development, process chemistry, QA/QC, Quality, R&D, RP-HPLC | Comments Off on Emerging Trends in Analytical R&D

6 Pharma API Regulatory Challenges to Watch

A couple of years ago, I published a post on 5 API Regulatory Challenges to Avoid, and it was interesting to look over the list and contemplate what updates I’d…

Posted in API synthesis, APIs, Big Data, FDA, genotoxic impurities, green chemistry, method development, Quality, regulatory, Route Design, Route Scouting, synthesis, Synthesis Route | Comments Off on 6 Pharma API Regulatory Challenges to Watch