In this podcast, I talked with Dr. Jimmy Li, CEO of WuXi XDC, a WuXi Biologics subsidiary. We discussed the reasons for the formation of WuXi XDC, which was established via a joint venture between WuXi Biologics and WuXi STA, a WuXi AppTec subsidiary, and how one-stop drug development organizations greatly streamline a pathway to the clinic. He also shares new technologies available to make the development of Antibody Drug Conjugates (ADCs) more efficient and effective. ...Continued

The benefits of using a single-source for discovery, development and GMP manufacture of antibody drug conjugates and other novel bioconjugates

In this podcast, I talked with Dr. Jimmy Li, CEO of WuXi XDC, a WuXi Biologics subsidiary. We discussed the reasons for the formation of WuXi XDC, which was established via a joint venture between WuXi Biologics and WuXi STA, a WuXi AppTec subsidiary, and how this company provides a true single-source for the discovery, development, and GMP manufacture of antibody drug conjugates and other novel bioconjugates with their highly efficient one-stop drug development platform....Continued

Applications and Impact of CRISPR/CAS9 in Bioprocessing

Experts from Wuxi Biologics talk about one of the great technological advancements of the last decade, CRISPR/Cas9 technology. We discussed the technology’s potential and in particular its possibilities in the discovery and development of biopharmaceuticals. We also conducted a deep dive on its potential impact on bioprocessing and biomanufacturing....Continued

Reducing Fill Risk in Drug Product Manufacture Utilizing New State-of-the-Art Systems and Platforms

In this podcast we talked with DQ Wang, PhD, and Vice President, Formulation, Fill and Finish of WuXi Biologics about their DP4 multi-product fill & finish facility featuring the Vanrx SA25 robotic, gloveless, isolator-based filling system. The system significantly reduces drug product fill risk and provides greater aseptic assurance....Continued

The Challenge of Staying Current with Regulatory Changes – How one company is providing a solution

In this podcast, we talked with Ken Chen, MBA, Senior Director, Regulatory Affairs, WuXi Biologics about staying current with regulatory changes. We discussed how WuXi Biologics recently began publishing a quarterly summary of regulatory updates on new or revised guidance documents from the various global regulatory agencies and how this is a valuable resource for anyone in the biological drug development arena....Continued

Antibody Drug Conjugate (ADC) Development and Manufacturing Challenges and Solutions

In this podcast, we interviewed Dr. J.J. Luo, Executive Director and Dr. Lily Yin, Head of Biologics Conjugation Development, at WuXi Biologics about the state of the ADC marketplace and the challenges in developing antibody drug conjugates. We then dove into reasons behind why they built a dedicated manufacturing facility for ADCs and other bioconjugates and how a single-source development platform can benefit bioconjugate drug development efforts....Continued

New Flexible Bispecific Antibody Format Demonstrates Improved Therapeutic Properties and Manufacturability

This year’s Next Generation Protein Therapeutics & Bioconjugates™ Summit held in San Francisco provided an in-depth look at the latest developments in next-generation protein therapeutic discovery and manufacturing. One talk that I found of particular ... Continued

Biologic Products DNA to IND Timeline in 9 Months – Yes it can be done!

The ability to rapidly develop biologic products from conception to human clinical trials is an increasingly important aspect of controlling drug development costs and in expediting the drug’s pathway to one day provide critical treatments. ... Continued

Is Continuous Biomanufacturing a Good Fit for Your Process? – Continuous Biomanufacturing Implementation – Frequently Asked Questions

We recently finished our Ask the Expert discussion, “Ask the Expert – Implementation of Continuous Manufacturing Strategies for Protein Therapeutics.” During this Ask the Expert session, we covered several common questions related to continuous biomanufacturing, ... Continued

Scale-Out Biomanufacturing – A Paradigm Change to Scale Up

In biomanufacturing, a production scale change is required to either meet the market growth demand or when a product moves from clinical to commercial manufacturing. How that volume is increased depends on whether a scale ... Continued

Implementation of Continuous Manufacturing Strategies for Protein Therapeutics

Answers by: Hang Zhou, Ph.D., Director of Cell Culture Process Development, WuXi Biologics & Sherry Gu, Ph.D, Vice President of CMC Management, WuXi Biologics Introduction There continues to be growing interest in continuous processing of biological therapeutics with the primary ... Continued

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