Newsletter | February 14, 2024

02.14.24 -- Mapping The Biosimilar Regulatory Landscape In The Middle East

SPONSOR

A Polishing Strategy For Removing Impurities In Bispecific Antibody Purification

Bispecific antibodies (bsAbs) are therapeutically promising due to their ability to bind to two different antigens. In this webcast, we demonstrate a polishing strategy using CHT™ Ceramic Hydroxyapatite media. The study achieved excellent removal of byproducts and impurities in a single chromatographic step, yielding purified products with low HCP contents and HCDNA levels. Explore this on-demand webcast to gain insights into this purification approach.

FEATURED EDITORIAL

Mapping The Biosimilar Regulatory Landscape In The Middle East

Countries in the Middle East and North Africa are promising markets for biosimilar drugs, but inconsistent regulations pose a challenge. Here's an overview of regulatory structures across the region.

INDUSTRY INSIGHTS

The Process Of Developing Monoclonal Antibodies For Clinical Use

Explore the potential of mAbs in treating diverse conditions, from cancer to infectious diseases, and learn about their transformation from scientific breakthroughs to life-changing therapies.

Combine Product And Process Insight With An Integrated Digital Backbone

Discover how to harness the power of data you generate through a digital data backbone, which allows you to transform the way you capture, analyze, report, and leverage data in upstream development.

The Promise Of PCM: Getting To Maturity

Pharmaceutical continuous manufacturing (PCM) offers a number of advantages. Review the key drivers for PCM and the hurdles that stand in the way of industrywide adoption.

Recombinant Proteins: Understand 5 Key Process Development Challenges

Once a company has demonstrated proof of concept, it is critical to consider process elements such as scalability, sourcing raw materials, and GMP adherence.

Improving Efficiency In Upstream Process Development

Explore the latest trends in cell culture technology, tools and enablers for scale-up, strategies to accelerate cell line development, media development, raw material characterization, and more.

Keys To A Successful cGMP Manufacturing Operation Delivering CGTs

Uncover the secrets behind successes in commercializing and producing commercial cell and gene therapies, including establishing standards of everyday manufacturing operational excellence.

Optimize mAb Purification Using Protein A Membrane Chromatography

Discover how high throughput (HTP) screening can utilize membrane chromatography at comparable consumables costs to traditional resins without compromising CQAs for prescribed therapeutics.

Tech Transfer In Sterile Injectables: 3 Phases Of Success

Explore the three phases of sterile injectable project tech transfer, including how to bridge information gaps and facilitate successful regulatory filing at this fundamental stage of drug development.

Investigating The Similarities Between Different Vendors’ 2X YT Liquid Media

Identifying variations in the expected nutrient profile before its use may prevent undesirable culture outcomes such as poor growth and low productivity.

The Microfluidic Platforms For Scaling Nanoparticle Production

Learn about the benefits of microfluidics for nanoparticle production over traditional methods as well as scaling nanoparticle production for clinical or industrial use.

Secure Tech Transfers Of Biological Products In Sterile Manufacturing

Recognizing what it takes to complete technology transfers effectively and efficiently is crucial to selecting the best partner for your project and product needs.

A Framework For Controlling Variability And Optimizing Assay Performance

Whether you are running analytical workflows for diagnostics, therapeutics, or vaccines, by applying process optimization throughout the assay workflow, you can improve overall assay performance.

Advances In Bioreactor Washing

Improve your cleaning and subsequent sterilization process for your bioreactors, ensuring a thorough cleaning, better reproducibility, and reduced labor.

Achieving Agile, Expert Scale-Up With New Manufacturing Capacity

Finding a manufacturing partner with the capabilities and capacity to offer truly end-to-end development and scale-up can mean the difference between successful commercialization and the end of the road.

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INTERPHEX is back in New York with exciting show features. This includes a brand-NEW Conference Program! The INTERPHEX Conference will unfold in the Learning Lab on the Exhibit Hall floor of INTERPHEX. It will feature peer-reviewed scientific presentations that examine quality systems, contamination control strategies for cell and gene therapies, 3D bioprinting, AI applications for formulations, and U.S. FDA regulatory updates, among other hot industry topics. Register today.

SOLUTIONS

Protein A ELISA Kits

Next-Generation Sequencing For Biologic Production And Safety

pDNA Lipid Nanoparticle Formulation And Screening Using Nova IJM

Control Software With Parallel Processing

Fluorokines For Immuno-Oncology Research

Cell Line Development Solutions

Sterile Fill/Finish Capabilities

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