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Category Archives: CRO/CMO

The Outsized Impact of Smaller Pharma CDMOs

One portion of an article at PharmTech (Five Themes That Will Drive the CMO Industry) discussing opportunities for smaller CMOs recently caught my eye. It mentioned that those aforementioned opportunities…

Posted in Capabilities, CDMO, Contract Manufacturing, CRO/CMO, Neuland Labs, outsourcing, process chemistry, QA/QC, Quality, R&D, regulatory, scale-up | Comments Off on The Outsized Impact of Smaller Pharma CDMOs

Pharma APIs and India’s National Security

I’m not usually given to using clickbait-type headlines that scream “the sky is falling!”, but I came across a recent article which is a bit eye-opening for our domestic drug…

Posted in APIs, Capabilities, Chemistry, CRO/CMO, Neuland Labs, outsourcing | Comments Off on Pharma APIs and India’s National Security

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

Advantages of a Pure-Play API Contract Manufacturer

Unlike many API Contract Manufacturing firms, Neuland is pure-play, meaning we do not compete against our clients in the generic formulations market. Differentiating ourselves this way enables us to offer…

Posted in APIs, Contract Manufacturing, CRO/CMO, IP, Patent, process chemistry | Comments Off on Advantages of a Pure-Play API Contract Manufacturer

APIs & Continuous Flow Manufacturing

Continuous drug manufacturing is reported to have begun with Novartis and MIT a decade ago, but no one would dare argue that it’s taken off like a rocket ship in…

Posted in API synthesis, CFM, Continuous flow manufacturing, continuous manufacturing, Contract Manufacturing, CRO/CMO, FDA | Comments Off on APIs & Continuous Flow Manufacturing

How Critical Chain Project Management (CCPM) Optimizes Pharma Innovation Timelines

In the pharma & biotech industries, Critical Chain Project Management (CCPM) plans and manages projects by emphasizing the available resources—such as people, equipment, and facilities—that can be used to complete…

Posted in CCPM, Chemistry, Critical Chain Project Management, CRO/CMO | Comments Off on How Critical Chain Project Management (CCPM) Optimizes Pharma Innovation Timelines

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,…

Posted in APIs, Capabilities, Contract Manufacturing, CRO/CMO, drugs, inhalables, injectables, micronization, particle size, Uncategorized | Comments Off on Challenges with API Micronization Techniques for Use in Injectables and Medical Devices

Moving Towards Specialty APIs

In a recent issue of PharmTech, Agnes Shanley wrote an article on the specialty markets and services driving the growth of APIs in which we were featured. For me, the…

Posted in API synthesis, Capabilities, Chemistry, CMC, Contract Manufacturing, CRO/CMO, Neuland Labs, outsourcing, Pharm Tech, Pharmaceutical Technology, QbD, Quality | Comments Off on Moving Towards Specialty APIs

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

Pharmaceutical API Contract Manufacturing: Reading Room

I’ve been trying to get caught up on some reading this month, and thought I’d put together a roundup of interesting articles I’ve run across recently. Grading GDUFA, at Contract…

Posted in analytical science, API synthesis, APIs, Chemistry, CMC, Contract Manufacturing, CRO/CMO, GDUFA, green chemistry, Pharm Tech, Pharmaceutical Technology, process chemistry | Comments Off on Pharmaceutical API Contract Manufacturing: Reading Room