Newsletter | June 6, 2024

06.06.24 -- Accelerate The mAb Formulation Process


Webinar: Key Elements of Process and Analytical Development to Support Biologics Tech Transfer

In this webinar our expert panel discusses the intricacies of technology transfer, drawing from real-life case studies. Investigate critical components for success, risk assessment, and effective mitigation strategies. Learn how to optimize your timeline and enhance efficiency in your transfer processes. Click here to learn more.


How To Unlock Efficiency In MES Integrations

This article outlines the significant benefits and framework for manufacturing execution system (MES) integration with systems such as enterprise resource planning.

New FDA Draft Guidance: Data Integrity For In Vivo Bioavailability And Bioequivalence Studies

The FDA's new draft guidance emphasizes maintaining data integrity throughout bioavailability/bioequivalence studies and provides recommendations for applicants and testing site management. The public comment period ends July 3.


Risk Control | Bulk Filling Application

Explore the advantages of a bulk filling system that enables you to achieve risk control, accuracy, and superior product recovery in your fill and finish operations.

Accelerating The mAb Formulation Process

Learn about a one-step process that was developed to streamline formulation, effectively reducing timelines from approximately 14 weeks to 8 weeks for this critical step.


Henlius Rituximab Receives Marketing Approval In Peru

FDA Approves First Interchangeable Biosimilar For Two Rare Diseases

European Medicines Agency (EMA) Validates Henlius And Organon Filings For Prolia And Xgeva (denosumab) Biosimilar Candidate HLX14

Samsung Bioepis Announces Oral Presentation On Switching Period Results For SB16, A Proposed Biosimilar To Prolia (Denosumab) At The European Calcified Tissue Society (ECTS) Congress 2024


Analytical Labs Particle Analysis

Combining Scientific Knowledge And Advanced Technology