Newsletter | May 28, 2025

05.28.25 -- Bridging Modalities: CDMO Innovation In CGT And Small Molecule Development

FOCUS ON CELL & GENE

Adapting A rcAAV Assay For Commercial Manufacturing

Integrating this assay into product release testing enhances patient safety by providing a rapid and reliable method to detect rcAAVs during commercial production.

 

CGMP-Validated RCL Assay Used For Release Testing Of Manufactured Viruses, Gene Mediated Cell Therapy Products

Addressing the risks associated with replication-competent lentiviruses (RCLs) is essential to ensure the safe and effective application of lentiviral vectors in advanced therapeutic interventions.

 

Advancing Viral Vector Manufacturing Through Next-Gen Plasmids

In this webinar, speakers explore key innovations in plasmid design and production, highlighting how these advancements can directly enhance biomanufacturing workflows.

 

Plasmid-IQ™: Accelerating CGT For Faster, More Efficient Solutions

Gain insights into the significance of plasmid design in viral vector production, the value of establishing a Plasmid Master Cell Bank (MCB), and the use of analytical assays and Next-Generation Sequencing (NGS) for plasmid verification.

 

Capacity Update April 2025: Cell & Gene Therapy

Our integrated expertise — from plasmid science to viral vector and cell therapy manufacturing — can accelerate and de-risk the development of your advanced therapies.

 

Cell & Gene Therapy Services

We're dedicated to solving your manufacturing challenges efficiently. Our services include high-throughput drug substance production, drug product manufacturing suites, integrated testing, and plasmid production.

 

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.

FOCUS ON SMALL MOLECULE

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.

 

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.

 

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.

 

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.

 

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.