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Successful Pharmaceutical Project Management

Think about your last project. How many individuals and departments participated? How many locations around the world did it involve? How smoothly did the project progress? Could you have improved…

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Complex Synthesis in Action: Achieving a Commercial-Scale 16 AA Peptide

Peptide process development projects have increased in the last few years. Judging by our blog readership and social interactions, interest in peptide drugs is continuing to grow by leaps and…

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Big Pharma Keeps Getting Bigger…by Shrinking?

An article at Pharma Manufacturing (Shrinking Big Pharma) pointed to the recent movement among Big Pharma towards smaller production floors. It comes as no surprise. With the rise of target-based…

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Overcoming Challenges in Complex Peptide Purification

Growth in Peptide Demand In its most recent market report, Grandview Research estimated the peptide therapeutics market will reach nearly $50 billion. Of particular interest is what is driving the…

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Neuland & Regulatory Excellence

With more than 650 regulatory filings to date, Neuland is committed to total compliance and regulatory excellence. In fact, we consider it our core competency: the application of strong process…

Posted in APIs, audit, award, Capabilities, CDMO, Contract Manufacturing, FDA, Neuland Labs, QA/QC, Quality, Quality Agreement, regulatory, Uncategorized | Comments Off on Neuland & Regulatory Excellence

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…

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Tips for Improving Quality and Yield in Solid Phase Peptide Manufacturing

Chemical synthesis of very long peptides and certain sequences considered difficult is always a challenge. In this post, we’ll share a few practical tips for improving various critical aspects of…

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At ContractPharma.com: an Industry Survey and a Little Green Chemistry

I recently came across two interesting articles in recent issues of Contract Pharma. One was their annual outsourcing survey, which I find often dovetails with our experiences at Neuland. The…

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Challenges with API Micronization Techniques for Use in Injectables and Medical Devices

Demand is steadily growing for pharmaceutical materials that contain micronized active drug substances (APIs) for inhalation and injectable delivery. Active pharmaceutical ingredients (APIs) are micronized for a number of reasons,…

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Quality Assurance & Control: Scaling QA & Monitoring Everything

At its core, Neuland’s philosophy is to meet or exceed quality levels defined by the customer, while also meeting stringent international standards. With multiple customer projects in the works at…

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