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Category Archives: Capabilities

Ensuring Rock-Solid IT Infrastructure in Contract Manufacturing

Digital transformation went from a popular corporate buzz phrase to an essential survival tool with the outbreak of the COVID-19 pandemic. Industries ranging from banking and restaurants to travel and…

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3 Key Elements of a Successful Hydrogenation Scale-Up

Pharmaceutical process chemistry has come a long way since wholesale merchants began the commercial marketing of drugs in the 19th century. In fact, process chemistry has driven many of the…

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What Does it Take to Become a Specialist in Late-Phase CMS?

When a drug transitions from early-stage development to late-stage development, the drugmaker has some big decisions to make. Chief among them: Who are they going to work with to move…

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How CMO Expertise Can Solve Key Challenges in Late Phase Drug API Projects

Stating the obvious here, but drug development is a protracted, expensive and risky process. From the lab bench to pharmacy shelves, bringing a new drug to market often stretches 10+…

Posted in APIs, Capabilities, Chemistry, CMC, Contract Manufacturing, CRO/CMO, drugs, method development, Neuland Labs, outsourcing, process chemistry, Process Engineering, scale-up | Tagged , , , , | Comments Off on How CMO Expertise Can Solve Key Challenges in Late Phase Drug API Projects

API Production: Building a Process Safety Culture

Working in the pharmaceutical manufacturing industry may bring many rewards, but it also has an element of risk. We often work alongside hazardous chemicals, in both labs and manufacturing spaces….

Posted in API synthesis, APIs, Capabilities, Chemistry, EHS, Neuland Labs, process chemistry, Process Engineering, safety | Tagged , , , | Comments Off on API Production: Building a Process Safety Culture

COPD Product Development Opportunity: Indacaterol Maleate

According to the American Lung Association, chronic obstructive pulmonary disease (COPD – which includes chronic bronchitis and emphysema) is the third-leading cause of disease-related death in the U.S. It affects…

Posted in Capabilities, COPD, CRO/CMO, DMF, drugs, FDA, generic, Indacaterol, marketing, Neuland Labs, Patent | Tagged , , , , , , | Comments Off on COPD Product Development Opportunity: Indacaterol Maleate

Solving the Insoluble

Soluble drug APIs are now the exception, not the rule. An article at PharmTech by Felicity Thomas (Looking Beyond the Solubility Horizon) caught my eye recently as it discussed a…

Posted in APIs, Capabilities, Chemistry, Contract Manufacturing, CRO/CMO, Pharm Tech, Pharmaceutical Technology, R&D, Route Design, Route Scouting, synthesis | Tagged , , , , | Comments Off on Solving the Insoluble

A Guide to Sourcing Pharmaceutical Peptide APIs

Rise of the Peptide Era                                                                                                                                                       Peptide synthesis has a long pharmaceutical history, stretching back to the early 1900s – and then followed by a lengthy period of dormancy….

Posted in API synthesis, APIs, Capabilities, Chemistry, chromatography, CMC, Contract Manufacturing, CRO/CMO, Fmoc, generic, HPLC, Jitsubo, Molecular Hiving, Neuland Labs, peptide, Peptide aggregation, peptides, process chemistry, Process Engineering, synthesis, Synthesis Route, TIDES | Tagged , | Comments Off on A Guide to Sourcing Pharmaceutical Peptide APIs

Inside Neuland Technology: Bosentan Monohydrate

Pulmonary arterial hypertension (PAH) is a rare disease affecting 1-2 people per million in the U.S. and Europe. The orphan drug Bosentan, a dual endothelin receptor antagonist, is used in…

Posted in API synthesis, APIs, Capabilities, Chemistry, Contract Manufacturing, drugs, generic, method development, Neuland Labs, Orphan drug | Tagged , , | Comments Off on Inside Neuland Technology: Bosentan Monohydrate

Case Studies from Neuland’s Process Engineering Lab

In our PE Lab, a team of 27 highly specialized engineers integrates the key attributes of QbD process understanding, process control, and continuous improvement with advanced equipment, Design of Experiments…

Posted in analytical science, API synthesis, APIs, Capabilities, Chemistry, Design of Experiment, method development, micronization, Neuland Labs, PAT, process chemistry, Process Engineering, QbD, Quality, Route Scouting, Synthesis Route | Comments Off on Case Studies from Neuland’s Process Engineering Lab