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…
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 clinical, CMS, drug development, late-phase, scale-up
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 chemistry, EHS, process safety, scale-up
Looking for an API Supplier? 5 Things to Consider (Updated)
Seven years ago – in March of 2013 – we published a blog post on 5 Things to Consider When Looking for an API Supplier. Because seven human years equals…
Posted in API synthesis, APIs, Chemistry, CMC, Contract Manufacturing, drugs, FDA, Neuland Labs, process chemistry, Process Engineering, Project Management, Quality, R&D, regulatory, supply chain, synthesis
Tagged API, regulatory, scale-up
Drug Scale Up: Planning for Clinical Success
Consistent – Yet Still Low – Clinical Success Rates The number of drug candidates which are approved, get to market and subsequently become profitable for industry is pretty low. And…