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Category Archives: CMC

How to Select a Peptide Synthesis Technique

Peptides are a complex drug class, and have historically proven challenging from a manufacturing standpoint. They are, however, experiencing a renaissance due to improvements in peptide synthesis, the development of…

Posted in API synthesis, Chemistry, CMC, Contract Manufacturing, method development, peptide, Peptide aggregation, peptides, process chemistry | Comments Off on How to Select a Peptide Synthesis Technique

5 Common Challenges Scaling Up an API

While linear drug scale-up sounds great on paper, the reality is usually much different. In fact, scaling up an API can be challenging even under the best circumstances. In fact,…

Posted in APIs, CMC, Contract Manufacturing, critical reaction parameters, CRO/CMO, method development, Neuland Labs, particle size, Route Design, Route Scouting, scale-up, synthesis | Comments Off on 5 Common Challenges Scaling Up an API

5 Variables Shaping the Contract Pharma-Client Relationship

Several posts ago, I discussed an article on the ‘shifting sands’ of contract provider/pharma relationships, and how smart providers were responding to pharma’s needs, rather than establishing fixed models of…

Posted in analytical science, API synthesis, Chemistry, CMC, Contract Manufacturing, CRO/CMO, Neuland Labs | Comments Off on 5 Variables Shaping the Contract Pharma-Client Relationship

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

8 Ways to Strengthen Your API Supply Chain Management and Sourcing

A pharmaceutical manufacturer is only as good as its supply chain. Supply chain management and strategic sourcing are the key drivers which keep operations running smoothly. Set the Right Inventory…

Posted in APIs, CMC, Contract Manufacturing, FTR, KSM, OTIF, supply chain | Comments Off on 8 Ways to Strengthen Your API Supply Chain Management and Sourcing

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

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

Purification of Peptides Using Surrogate Stationary Phases on Reversed-Phase Columns

Earlier this month, we published a post on Improving Quality and Yield in Solid Phase Peptide Manufacturing. In recent years, peptides have been acknowledged for their selectivity, efficacy and safety. Combined…

Posted in APIs, Chemistry, chromatography, CMC, HPLC, peptide, Peptide aggregation, peptides, RP-HPLC | Comments Off on Purification of Peptides Using Surrogate Stationary Phases on Reversed-Phase Columns

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

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