Newsletter | May 27, 2025

05.27.25 -- Navigating NDSRI Compliance And Optimizing API Purification

Simulated Bed Chromatography Advantages

Discover how Simulated Moving Bed (SMB) technology can revolutionize your purification processes by enhancing efficiency, reducing costs, and promoting sustainable practices.

 

Demystifying Large Scale Continuous Chromatography For Small Molecules

Review real-world examples highlighting the numerous advantages of SMB technology, including rapid development timelines, seamless scalability, and compliance with cGMP standards for API manufacturing.

 

2025 And Beyond — A Look At Upcoming NDSRI Regulations

Pharmaceutical companies must urgently secure a reliable nitrosamine testing partner by August 2025 to ensure compliance with FDA guidelines. Inaccurate testing could result in regulatory non-compliance.

 

IN THE NEWS

SK pharmteco Expands Stability Storage Capacity In California To Support Small Molecule Drug Substance And Drug Product Programs

SOLUTIONS

ADC Payload-Linker Services

Explore how advanced high-potency capabilities and specialized expertise are driving the development and manufacturing of next-generation ADC payloads and linkers.

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Small Molecule CDMO Services

We specialize in the custom development and manufacturing of small molecule APIs, intermediates, and RSMs, offering scalable solutions from kilograms to multi-ton quantities.

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INDUSTRY EVENT

 

SK pharmteco At The BIO International Convention

Meet SK pharmteco in Boston, MA, from June 16-19, 2025, at the BIO International Convention. Discover our industry-leading CDMO services, enabling the advancement of both small molecule and cell & gene therapies to bring your innovations to life.