Newsletter | April 3, 2025

04.03.25 -- Optimize Downstream Separation With Tagless Proteins

FEATURED EDITORIAL

How To Optimize Downstream Separation With Tagless Proteins

The intein-based magnetic bead system enables effective affinity capture, tag removal, and buffer exchange, supporting direct analytical applications.

Pharma 4.0 Adoption Needs Cooperation — Here's How To Build It

A recent survey by the International Society for Pharmaceutical Engineering found that an inadequate company culture raised the greatest barrier to digital maturity.

Deciphering FDA's 7-Step Framework For AI-Driven Decision-Making

The draft framework, published in January, aims to ensure that AI systems used in drug development are robust, reliable, and aligned with regulatory expectations.

INDUSTRY INSIGHTS

Assessment Of A Biosimilar Interferon In Process Development

Biosimilars are considered to be one of the fastest growing sectors of the pharmaceutical industry. Discover how to develop biosimilars using systems to achieve accurate comparability assessments.

Accelerate Your CHO Bulk Harvest Testing Using Rapid Methods

With advanced rapid methods that offer both speed and sensitivity, you can expedite your bulk harvest testing and detect adventitious viruses in half the time compared to conventional techniques.

NEWS HEADLINES

Xbrane Has Entered Into An Agreement To Sell XB003 (Cimzia Biosimilar Candidate) And Parts Of Its Organization To Alvotech For A Total Consideration Of SEK 275 Million

UK Medicines And Healthcare Products Regulatory Agency Confirms Acceptance Of Marketing Authorization Application For Proposed Biosimilar To Xolair® (omalizumab)

African Development Bank Approves EUR 15 Million Loan To Boost Biosimilars' Development And Production In Egypt

Fresenius Receives FDA Approval For Their Denosumab Biosimilars And Secures Global Settlement Agreement

Celltrion's Remdantry, Previously Known As Inflectra, Will Be Available In Canada As Of April 1, 2025