Existing regulatory landscape, guidance and regulations applicable to cell and gene therapy products, hot topics related to manufacturing facilities to be considered during regulatory filings, Segregation measures and controls.
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Woman examining capsule
R&D Blog post
Developing Breakthrough Technology for Oral Solid Dosage Forms
Delivering treatment in the small intestine and not the stomach represents a unique drug delivery...
Sustainability webinar
Whitepaper/Executive Summary
Reducing Wastewater Incineration and Carbon Emission
As the pharmaceutical industry works to develop more sustainable processes for large-scale drug...
Video
The CDMO Value Proposition of Experience for Your Autologous Cell Therapy
bluebird bio and Lonza take the opening plenary stage at the CAR-TCR Summit to tell the story of...
Embrace molecule complexity
Whitepaper/Executive Summary
Overcome Challenges And Secure Successful Technology Transfers Of Complex Biological Products In...
A critical area to consider in selecting a CDMO is their ability to successfully complete technology...
a technician uses a machine to fill vials with a liquid substance
Article
Addressing Challenges with Clinical In-Use Testing of Biotherapeutics
The goal of in-use testing of biotherapeutics is to ensure acceptable product quality during dose...
a scientist holds a small vial up to inspect it
Article
How to Accelerate Your Biotherapeutics' Path to Clinic
Over the last few decades, many novel biotherapeutics have undergone clinical trial testing in the...
Peer-reviewed publication
Automated production of gene-modified chimeric antigen receptor T cells using the Cocoon® Platform
Abstract: Autologous cell-based therapeutics have gained increasing attention in recent years...
Article
Strategies to Optimize Expression Challenges of Multi-chain and Bispecific Antibodies
Many of today's expression platforms for recombinant protein manufacturing have been optimised for...
Webinar (on-demand)
Transfer and Development of Mammalian Processes: Effective technology transfer for mammalian derived...
Translating innovations from research laboratories to clinical and commercial manufacturing is a...
Article
Tools for Developing Successful Biologics - XS Pichia® Expression System
Lonza subject matter experts talk about the XS® Pichia Expression System and how it could benefit...
Article
Successfully Transitioning mRNA Production to cGMP Requires Early Process Engagement for Developing...
Discover why early process optimization is key to developing an efficient, cost-effective cGMP...
Technical/Service brief
XS Technologies® Microbial Platform for Protein Expression Brochure
XS Technologies® are the microbial expression systems for today’s therapeutics. While...