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Category Archives: scale-up

Contract API Manufacturing Challenges: From Micro-batches to Multi-Tons

With technology racing onward, drugs are becoming more complex than ever before – along with their active ingredients and the processes that produce them. Different Challenges, Different Scales – The…

Posted in Contract Manufacturing, drugs, method development, Route Design, Route Scouting, scale-up | Comments Off on Contract API Manufacturing Challenges: From Micro-batches to Multi-Tons

Successful Pharma Partnering: Managing the CMO Relationship

With everything involved in bringing a drug to market, enlisting the services of an experienced CMO can prove to be a very worthy investment. Ideally, the relationship between a pharma…

Posted in agreement, APIs, Contract Manufacturing, CRO/CMO, guarD, Project Management, Quality, scale-up | Comments Off on Successful Pharma Partnering: Managing the CMO Relationship

No Straight Line: Confronting API Scale-Up Challenges

In many of the blog posts we’ve written over the last few years, we’ve referenced the growing complexity of active pharmaceutical ingredients (APIs). It isn’t just mindless chatter intended to…

Posted in CMC, Contract Manufacturing, CRO/CMO, R&D, Route Design, scale-up | Comments Off on No Straight Line: Confronting API Scale-Up Challenges

Peptide Process Chemistry – A New Era?

Since pioneers such as Bodanszky and Du Vigneaud first produced them synthetically in the 1950’s, peptides have always held tremendous – but unrealized – promise for human health. Despite their…

Posted in APIs, Capabilities, cardiovascular disease, Contract Manufacturing, drug delivery, genotoxic impurities, Neuland Labs, oncology, peptide, peptides, R&D, scale-up, transdermal | Comments Off on Peptide Process Chemistry – A New Era?

You Can’t Keep a Good Drug Down

Reducing Mutagens, Carcinogens & Other Genotoxins to Improve Safety Profiles There are a number of process modifications API manufacturers can make to improve safety profiles, reduce production costs, improve capacity…

Posted in analytical science, APIs, Capabilities, Chemistry, CMC, Contract Manufacturing, critical reaction parameters, CRO/CMO, drugs, EHS, genotoxic impurities, green chemistry, method development, Neuland Labs, QA/QC, QbD, R&D, regulatory, Route Design, scale-up, Synthesis Route, zero liquid discharge | Comments Off on You Can’t Keep a Good Drug Down

APIs & Chemistry: The Importance of Understanding Critical Reaction Parameters

Active Pharmaceutical Ingredients (APIs, or – in layman’s terms – the ingredients that makes drugs work) have grown increasingly complex. Today’s equivalent of boiling tree bark into a tincture typically…

Posted in analytical science, Capabilities, Chemistry, critical reaction parameters, drugs, genotoxic impurities, method development, QA/QC, R&D, scale-up | Comments Off on APIs & Chemistry: The Importance of Understanding Critical Reaction Parameters

Neuland – Thirty Years of Global Pharma, Process Chemistry & APIs

Hitting a milestone such as 30 years old as a pharmaceutical manufacturing company is a pretty big deal. Pharma – as you can imagine – has changed. A lot. Thirty…

Posted in Capabilities, Chemistry, Contract Manufacturing, DMF, FDA, Neuland Labs, Project Management, R&D, regulatory, scale-up | Comments Off on Neuland – Thirty Years of Global Pharma, Process Chemistry & APIs

API Micronization & Nanosizing: Mastering Particle Size

Micronizing – and particularly nanosizing – active pharmaceutical ingredients (APIs) has become an integral part of the drug development & manufacturing process. And with a variety of techniques available to…

Posted in APIs, Chemistry, CMC, drug delivery, R&D, scale-up | Comments Off on API Micronization & Nanosizing: Mastering Particle Size

Made in India: The Outlook for Pharma’s Manufacturing Hub

I’ve written before about the incredible speed of the Pharma industry’s growth in India, and the future outlook continues to look very bright. While the Indian pharma market is facing…

Posted in Contract Manufacturing, CRO/CMO, DMF, FDA, regulatory, scale-up | Comments Off on Made in India: The Outlook for Pharma’s Manufacturing Hub

Overcoming Scale-up Issues: When Your CRO Becomes Your CMO

The transition from discovery and research to full manufacturing marks a critical time in a drug candidate’s lifecycle. Whether a company completes the scale-up process entirely in-house, with a single…

Posted in APIs, Contract Manufacturing, CRO/CMO, scale-up | Comments Off on Overcoming Scale-up Issues: When Your CRO Becomes Your CMO