Newsletter | February 15, 2024

02.15.24 -- When Does Continuous Manufacturing Make Sense?

FEATURED EDITORIAL

Novel Approaches For Obtaining High-Productivity Clones

Let's dig into cell line selection approaches, transposons to increase copy number for the gene of interest, and targeted integration to rapidly obtain high-productivity clones.

When In The Product’s Life Cycle Does Continuous Manufacturing Make Sense?

This overview article takes a look at each product development stage for biopharmaceuticals to illuminate when continuous manufacturing can satisfy important business drivers.

INDUSTRY INSIGHTS

Selecting Drug Delivery Systems For Higher Doses And Higher Viscosities

Discover how companies can de-risk their device selection as they bring this new generation of high-volume, high-viscosity biologics to market.

Viral Clearance: Something Went Wrong, What Do I Do Now?

Even the strongest study design may encounter issues with clearance to reach the target safety expectations. Learn how to troubleshoot these and manufacturing deviations that impact viral safety.

Impact Of Immunogenicity On Efficacy And Safety Of Biosimilars

The presence of anti-drug antibodies (ADAs) can affect the effectiveness and safety of biologic drugs. Read why regulatory agencies emphasize the need for extensive immunogenicity evaluation in biosimilar development.

NEWS HEADLINES

rBIO Completes Analytical Characterizations Of R-Biolin, Readies Biosimilar Insulin Drug For Clinical Trial

Rani Therapeutics Announces Positive Topline Results From Phase 1 Study Of An Oral Anti-Interleukin 12/23 Antibody (RT-111)

Biocon Biologics Partners With Sandoz Australia For Biosimilars Trastuzumab And Bevacizumab

SOLUTIONS

Allegro Connect Bulk Fill System