Seqens North America

02/03/2023

09/15/2022

The role of ICH in helping to raise the quality and safety of APIs in drug development

This article addresses the role of ICH as a global standards body and how to ensure compliance in API manufacturing

09/13/2022

Manufacturing APIs for Injectables Requires a Safety-First Approach:
Maintaining Clean Room Operations is Key to Safety, 5 Best Practices to Follow

Understanding the critical role of cleanroom operations when manufacturing APIs for injectable drugs

09/12/2022

What Has Changed in Method Development and Validation for Pharmaceuticals and Why You Need to Know: The 4 best practices that assure robust method validation

Why the traditional approach to developing DMFs, NDAs and ANDAs is no longer acceptable—and what you can do today

09/09/2022

The Role of ICH and How to Meet Quality Guidelines in API Manufacturing: 5 Steps to Meet ICH Guidelines

This article addresses the role of ICH as a global standards body and how to ensure compliance in API manufacturing

09/08/2022

The Many Reasons to Choose an Integrated CDMO for Your Projects
Why demand is high for integrated CDMO services

What value does a fully integrated CDMO provide?

09/02/2022

What are the 10 best practices in API R&D?

Why and how stellar R&D and an integrated CDMO provide the fastest road to API approval and first-mover advantage.

09/01/2022

What CDMO Capacity Refers to and What to Look For
Overcapacity & Under-capacity are Red Flags

Having trouble finding a CDMO with capacity for your project? What you need to know about managing capacity.

08/31/2022

APIs: the Superheroes of Drug Development
Accelerating Your Drug Development Projects with Proprietary APIs

This article describes the value of proprietary APIs and how to work with a CDMO to best leverage them

08/26/2022

The Fastest Road to API Manufacturing is Exceptional R&D
The 10 best practices in API R&D

Why and how stellar R&D and an integrated CDMO provide the fastest road to API approval and first-mover advantage.

08/25/2022

CDMOs can maintain a collaborative, long-lasting relationship with sponsors.

Two of the most gratifying things I’ve experienced in my two decades of running a CDMO have been the loyalty of my staff, and the collaborative, often lasting relationships we have built with sponsors. Internally, the majority of Seqens CDMO NA’s (formerly PCI Synthesis) scientists, project mana...