Newsletter | February 7, 2025

02.07.25 -- GlycoNex On Challenges In Biosimilar Development, Manufacturing

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Following its popular inaugural 2024 Bio-Expo Live, Bioprocess Online brings you the next opportunity to advance your drug development agenda. Over just a small portion of your week and from the comfort of your computer, discover the latest solutions in upstream and downstream bioprocessing as well as bioprocess quality, data, and analytics. 15-minute presentations from leading suppliers will give you just the right insight to make your next best move in drug development. Register here.

FOCUS ON QUALITY/ANALYTICAL METHODS

GlycoNex On Challenges In Biosimilar Development, Manufacturing

In this written Q&A, GlycoNex president and CEO, Dr. Mei-Chun Yang, shares insight into the company's development of its denosumab biosimilar, SPD8. She covers the company’s approach to analytics, cell line development, scaling, and more.

Purification And Solubilization Of Membrane Proteins For Cryo-EM Studies

See how Cube Biotech and MIT researchers used dynamic light scattering (DLS) and nano differential scanning fluorimetry (nanoDSF) to find the best nanodisc conditions for three membrane proteins.

Exploring New Analytical Methods For Traditional And Unique Modalities

Webinar | Catalent

Here, we review several challenges in biologics analysis and take a closer look at the advanced tools and methods being utilized to improve biophysical analysis reliability and efficiency.


Assessing mAb Quality Through Direct Spent Media Analysis

Learn about an innovative tool that offers direct analysis of spent media, revealing key product quality attributes (PQAs) of monoclonal antibodies (mAbs) that ensure optimal mAb quality and productivity.

A Flow Cytometry Toolkit To Measure Expression Of Metabolic Proteins

Learn about a method that utilizes monoclonal antibodies and flow cytometry to analyze the metabolic state of individual immune cells, advancing immune research and immunotherapy.

Biocompatibility Of CHO Cell Culture In X-Ray Irradiated Bioreactors

In cell culture, the leakage of toxic or inhibitory chemicals from single-use bioreactors has become a growing concern. Explore recommendations for leachable studies.

QUALITY/ANALYTICAL METHODS SOLUTIONS

Accelerate Biologics Development With Electroporation Technology - MaxCyte, Inc.

Development Of A Mitra Tip Extraction Assay Coupled With LC-MSMS - Aliri Bioanalysis

Chip-R1 Basic Research Kit - Emulate

Genedata Profiler - Danaher Life Sciences

NEW PODCAST EPISODE

BoB@JPM: Stefan Scherer, M.D., Ph.D., 3T Bioscience

From the JP Morgan Healthcare Conference, Dr. Stefan Scherer of 3T Biosciences shares insights on transitioning from clinical medicine to drug development. He discusses the promise of T-cell therapy, the challenges of advancing a biotech from platform development to lead candidate status, and the hurdles of staffing and funding. Tune in to the Business of Biotech for an in-person conversation on leadership and innovation.

FOCUS ON REGULATORY

Unlocking Audit Success: Navigate Compliance With Confidence

Watch expert Kathianne Ross explore ALCOA+ principles, audit preparation strategies, and the role of digital validation in enhancing compliance and audit success.

The Aqueous Cleaning Handbook

This handbook is intended to assist laboratory and manufacturing plant scientists and engineers in accurately selecting and maximizing the performance of aqueous cleaners and systems.

How To Prove A Sterility Assurance Level Of 10⁻⁶

Explore the Biological Indicator/Bioburden (BI/BB) method for achieving sterilization of products along with the prerequisite studies needed to develop the sterilization process.

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