06.24.25 -- A Psychedelic Path To CDMO Selection?

This webinar outlines the evolving CMC regulatory landscape for protein-based drugs, from preclinical to post-market stages. Through case studies, it shows how Lonza supports clients with integrated regulatory services. Key takeaways include the value of strategic planning, adapting to varied agency expectations, and partnering with experienced CDMOs to ensure regulatory success. Click Here to Learn more.

This article, the first in a two-part series, focuses on the initial stages of product development — specifically, how to move from candidate selection to a Phase 1 IND application.

If you’re hoping to improve your QC toolkit to better accommodate complex modalities like cell and gene therapies, it's time to build a program that accounts for risk and unique product characteristics.

Discover how our engineered plasmids dramatically enhance AAV vector yield, quality, and scalability, offering a powerful, next-generation solution to today’s gene therapy manufacturing challenges.

What you need and what a CDMO can offer specifically, the nuances of your development program, and the way both sides approach the outsourcing relationship will determine a successful development path.

Don’t miss this compelling interview with Boro Dropulić, CEO of Caring Cross, on how the cell and gene therapy sector can turn scientific breakthroughs into global health solutions.

See how Codex HiCap RNA Polymerase supports the production of high-performance synthetic mRNA, paving the way for next-generation mRNA therapies.

Streamlining the tech transfer process is a key variable in shortening development timelines and controlling costs, maximizing a molecule's potential for late-stage success.

Explore a description of research grade and process development productions of rAAV6, both based on transient transfection of serum-free cells grown in suspension.

Gain essential insights and practical guidance on outsourcing drug development and manufacturing, helping you make informed decisions and accelerate the success of your therapeutic initiatives.

Leveraging our optimized Ascend HEK293 suspension platform and genome-wide microRNA screening, we invite collaboration to advance rAAV production efficiency.

This comprehensive exploration aims to shed light on the critical aspects of expediting curative therapies, with a focus on the strategic role that CDMOs can play in this transformative journey.

Review how you can significantly increase efficiency for various AAV serotypes and client-specific Genes of Interest (GOIs) at the upstream production stage through plasmid engineering approaches.

Examine how self-replicating RNA (srRNA) can revolutionize vaccine development with sustained protein expression, lower doses, and fewer side effects to advance next-gen RNA therapeutics.

Mathias Kahl, Director of Process Development, shares insights on overcoming challenges in AAV and LV viral vector manufacturing.

To successfully bring your biotherapeutic to market, take a critical step toward commercialization to reduce manufacturing risk.

Witness the intricate complexity of cells with unmatched precision through advanced high-dimensional multiomics solutions.

Learn how the right partner can leverage years of experience, market knowledge, industry relationships, and clinical packaging expertise to develop a sourcing strategy tailored to the needs of each study.

Time to optimize your cell therapy process for cGMP manufacturing. We offer R&D services, including process development and cGMP production for Phase 1 through commercial manufacturing.

To jump start iPSC derived therapeutic cell product development; achieve reliable and efficient genome integration with our innovative solutions.

Consider how vial labeling demands precise, high-speed systems to ensure accurate and reliable product identification, in the pharmaceutical industry, where safety and compliance are paramount.