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Category Archives: QbD

How Neuland’s Process Engineering Lab Supports Robust Design and Minimizes Risk

Drug developers know that processes which operate in a defined design space can be made more consistent, safer and less prone to deviation. At Neuland, process development begins in the…

Posted in analytical science, Chemistry, process chemistry, Process Engineering, QbD | Tagged , , , , , | Leave a comment

Where Does Pharmaceutical Process Control Start?

The idea of gaining – and maintaining – adequate process control during drug synthesis isn’t new. It underscores the entire point of approaches such as Quality by Design (QbD), and…

Posted in API synthesis, APIs, Chemistry, CMC, process chemistry, QbD, Quality, Route Design, Route Scouting | Tagged , , , | Comments Off on Where Does Pharmaceutical Process Control Start?

Unique API Particle Size Projects On the Rise

Why is there a growing preoccupation with particle size? It’s because particle size can alter the efficacy (e.g., bioavailability) and safety profile (e.g., toxicity) of a compound. Complex particle sizing…

Posted in APIs, Chemistry, CMC, drugs, Impurity profile, micronization, Neuland Labs, particle size, process chemistry, Process Engineering, QbD | Comments Off on Unique API Particle Size Projects On the Rise

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

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

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

Inside QBD: Chemists & Engineers Collaborate on Quality

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

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

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

Quality by Design: Essential, Not Optional

In today’s pharmaceutical industry, Quality by Design (QbD) has become an essential – instead of optional – tool. In fact, the phrase, “essential instead of optional” reminds me of the…

Posted in API synthesis, APIs, Chemistry, CMC, FDA, Neuland Labs, outsourcing, QbD, Quality, regulatory | Comments Off on Quality by Design: Essential, Not Optional