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Yearly Archives: 2016

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

What are the Key Differences with Orphan Drug Manufacturing?

I was asked recently what a contract manufacturer such as Neuland Labs saw as the key differences with orphan drug projects. Neuland approaches orphan drug projects slightly differently from our…

Posted in deuterium exchange, drugs, FDA, Orphan drug | Comments Off on What are the Key Differences with Orphan Drug Manufacturing?

Confronting Global API Supply Chain Challenges

Lately, I’ve been thinking about the subject of global API supply chain challenges. There have been a few articles recently, but it isn’t a new topic. Global drug supply chain…

Posted in APIs, DCAT, supply chain | Comments Off on Confronting Global API Supply Chain Challenges

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

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

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…

Posted in Uncategorized | Comments Off on Quality Assurance & Control: Scaling QA & Monitoring Everything

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

Analytical Prep-RP-HPLC: New Method Dramatically Improves Sample Loadability

In this post, we’ll look at a unique Prep-RP-HPLC method developed at Neuland Labs to achieve 10-fold increases in sample loadability. Despite advances in technology, there are only two ways…

Posted in Capabilities, chromatography, HPLC, Neuland Labs, peptide, peptides, RP-HPLC | Comments Off on Analytical Prep-RP-HPLC: New Method Dramatically Improves Sample Loadability

The Promise of Peptides: Developments in 3 Key Areas Reawaken Therapeutic Potential

In a post last month, we discussed the three types of peptide production techniques Neuland uses to cGMP manufacture peptide APIs and NCEs for clients. We also mentioned some of the…

Posted in APIs, Chemistry, CMC, Contract Manufacturing, drug delivery, drugs, Fmoc, Neuland Labs, peptide, Peptide aggregation, peptides, process chemistry, synthesis, Synthesis Route | Comments Off on The Promise of Peptides: Developments in 3 Key Areas Reawaken Therapeutic Potential