Newsletter | April 1, 2026

04.01.26 -- FDA's Final NDC Rule Provides A 900-Year Supply Of Label Codes

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2026 ISPE AI in Life Sciences Summit – Powered by GAMP®

The 2026 ISPE AI in Life Sciences Summit – Powered by GAMP® will be held 22–23 June in Boston, offering insight into how AI is advancing within the life sciences sector. Sessions explore model governance, data integrity, explainability, and inspection ready design. Attendees gain practical frameworks for integrating AI into GxP workflows and guidance on how to meet evolving regulatory expectations. LEARN MORE

FOCUS ON FILL-FINISH

FDA's Final NDC Rule Provides A 900-Year Supply Of Label Codes

FDA won't offer a waiver process or phased implementation. Instead, the agency is providing a seven-year runway to transition to a new labeling format.

Key Metrics In Antibody Drug Development

Explore key techniques like DSC and Rheology to assess thermal stability and viscosity in antibody drug development. Gain practical insights to enhance biologic candidate selection, formulation, and delivery.

The Case For Modernizing Small-Volume Aseptic Processing

Tube welding and biosafety cabinets present significant costs and risks for small-volume aseptic processing. Modern single-use aseptic connectors offer a more efficient alternative.

FILL-FINISH SOLUTIONS

Handle Your Drug Product With The Highest Quality And Safety - FUJIFILM Biotechnologies

FOCUS ON DOWNSTREAM MANUFACTURING

Guide To PUPSIT And Annex 1 In Aseptic Processing

Pre-use, post-sterilization integrity testing (PUPSIT) ensures filters remain undamaged and effective during aseptic manufacturing. Discover how you can successfully perform PUPSIT with proven solutions.

High Purity And Recovery With Adjustable Selectivity

Uncover a resin that enables high-yield purification of complex biomolecules, as well as supports fast flow rates, consistent recovery, and scalable performance for downstream processing.

High-Efficiency Preparative Chromatography To Improve Yields

Improve purification workflows for complex GLP‑1 peptides with practical guidance. Learn how to boost resolution, uncover hidden impurities, and increase yield across analytical and preparative workflows.

The Rise In Aseptic Manufacturing Solutions With Smaller Footprints

Aseptic drug manufacturing is going small. Examine how advanced robotic and automated systems with smaller footprints are changing the landscape and boosting accessibility.

DOWNSTREAM MANUFACTURING SOLUTIONS

Modern Bioprocessing Separation: Reliable, Automated, Scalable - CARR Biosystems

An Automated TFF Platform For Small Volumes - Repligen

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