Newsletter | August 14, 2025

08.14.25 -- Preparing For FDA's Expanded Use Of Unannounced Inspections At Foreign Facilities

SPONSOR

The Festival of Biologics is the meeting place for the life science community to bridge the gap between academia and industry, covering the start to finish of biologics from discovery, through development, to manufacturing, clinical trials and commercialization. Register now to join Europe's largest biologics event and use LSC20 to get 20% off!

INDUSTRY INSIGHTS

Pre-Use Post Sterilization Integrity Testing (PUPSIT) Overview

Successfully implementing PUPSIT requires balancing regulatory compliance with operational efficiency. Gain insights into regulations and expert solutions to help streamline your manufacturing process.

FEATURED EDITORIAL

Pharma Enterprise Resource Planning: From Automation To AI-Driven Insights

Pharmaceutical firms are increasingly turning to enterprise resource planning (ERP) systems to modernize operations. These platforms unify core functions, including supply chain management, manufacturing, and financial planning and analysis.

Preparing For FDA's Expanded Use Of Unannounced Inspections At Foreign Manufacturing Facilities

The FDA announced on May 6, 2025, that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. Here are key considerations and actions to take in order to be prepared.

How Much Knowledge Work Can Biopharma Offload To AI? Answer: Not Much

In biomanufacturing, knowledge work and manual work are deeply intertwined. One expert suggests replacing entire workflows with artificial intelligence seems unlikely.

NEWS HEADLINES

Intas Pharmaceuticals And Accord Biopharma Become One Of The Largest Global Suppliers Of Pegfilgrastim With Acquisition Of UDENYCA®

CivicaScript® To Distribute Low-Cost Biosimilar To Treat Chronic Inflammatory Conditions

Polpharma Biologics And Fresenius Kabi Sign Licensing Agreement For Proposed Vedolizumab Biosimilar PB016

Kashiv BioSciences And MS Pharma Enter Into MENA License And Supply Agreement For ADL-018, Biosimilar Candidate To XOLAIR (bOmalizumab)

SOLUTIONS

Viral Clearance Services