Newsletter | September 4, 2025

09.04.25 -- Accelerate Process Development With Automated Aseptic Sampling

SPONSOR

The PDA Pharmaceutical Microbiology Conference 2025 marks two decades of advancing microbiological science and practice. This milestone event brings together the global microbiology community, including experts from industry, academia, and regulatory agencies, to explore the evolving landscape of pharmaceutical microbiology. This year's theme, Microbial Resilience: Today's Response, Tomorrow's Plan, reflects our focus on navigating present-day challenges while building robust strategies for the future.

INDUSTRY INSIGHTS

Accelerate Process Development With Automated Aseptic Sampling

Discover how implementing automated sampling systems enabled Takeda Pharmaceuticals to achieve new efficiencies in process development.

The Patent Cliff Looms – Design Your Biosimilar Approach Accordingly

In your pursuit of developing a high-quality biosimilar, think strategically. Consider what type of biologic your team’s expertise can support and which is needed most in your target market.

FEATURED EDITORIAL

EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance

The EMA issued three new draft documents in July, all related to the advancement of the use of electronic technology in GMP: AI, computerized systems, and documentation. The public comment period ends Oct. 7.

Lean Manufacturing Implementation In Pharmaceutical Injectable Facilities

This comprehensive analysis examines lean manufacturing implementation challenges and evidence-based solutions derived from leading pharmaceutical organizations. 

NEWS HEADLINES

The European Commission (EC) Approves Bio-Thera Solutions' BAT2206 (USYMRO®, ustekinumab), A Biosimilar Referencing Stelara®

Bio-Thera And STADA Extend Biosimilars Alliance To Tocilizumab

Abbott Receives Regulatory Approval For The First Denosumab Biosimilar In Thailand, Expanding Access To Bone Disease Treatment

SOLUTIONS

A Versatile And Modality-Agnostic Aseptic Autosampling Solution

Protein A Resin With High Binding Capacity