11.11.25 -- A (Partial) Vindication For Wuxi AppTec … And Global Outsourcing

Intensified adherent cell culture offers a promising solution to the limitations of traditional suspension culture, with the potential to improve efficiency, reduce costs, and accelerate development.

As cell and gene therapies advance to commercialization, biopharma companies face immense logistical hurdles. A customized, end-to-end strategy is crucial for ensuring product integrity and market success.

As developers begin their research, conducting early-phase studies with an experienced CDMO can help mitigate funding challenges and secure materials for clinical data generation.

The CRISPR-iPSC combination is becoming a core tool for precision medicine with advanced editing efficiency, differentiation control, and safety profiles.

Unvalidated shipping lanes and incomplete documentation can cause regulatory delays. Proactive qualification and risk assessments are vital for compliance and safeguarding product integrity.

Cell and gene therapies offer transformative potential for treating complex diseases, but their manufacturing and global delivery face significant challenges.

Discover how a systematic approach to autologous cell therapy manufacturing can reduce costs, improve reliability, and accelerate access to life-changing treatments.

Vector redesign and regulatory hurdles can add years to development timelines. A single-partner approach helps streamline the process, secures timelines, and ensures smooth tech transfer.

Managing timelines to IND is the top challenge in cell therapy, impacting funding, patent value, and patient access amid competitive, capital-constrained development environments.

Learn how off-the-shelf, GMP-grade iPSC lines with a Drug Master File (DMF) can accelerate cell therapy development, streamline regulatory approval, and reduce time and cost to clinic.

Consider how Buoyancy Activated Cell Sorting (BACS) can streamline T cell isolation, reduce costs, and enhance CAR T and TCR cell therapy manufacturing — access the full study to learn more.

Delve into the current state-of-the-art in RNA nanoparticle formulation and examine the technologies and strategies used to optimize RNA delivery for preclinical and clinical development.

Cell and gene therapy has evolved from a niche concept to a booming sector in just five years, with over 1,300 companies and growing momentum in innovation, investment, and regulatory approvals.

Explore the building blocks of plasmid manufacturing capability, highlighting how one approach supports AAV programs by helping manage production costs while maintaining high productivity.

Now that you have the best donated cellular material, it is time to optimize your cell therapy process for cGMP manufacturing. We offer R&D services for Phase 1 through Commercial manufacturing.

Beyond offering our GMP-compliant iPS cells, we develop superior workflows for gene editing and differentiation to provide competitive platforms to our partners and accelerate their therapeutic programs.

Work with us from start to finish of your product or partner with us at any stage of your project — preclinical through commercial scale.

For cell expansion to occur, we use the world-leading cell line: Pro10™ by AskBio. Viralgen is the only company in the world with a license to manufacture for third parties.

Consider how a one-stop solution for your cell therapy needs can help ensure efficiency, cost-effectiveness, and faster patient treatment. Our Draw-to-Thaw® service streamlines the entire process.

Our comprehensive Adenovirus Vector Lot Release Package ensures the quality and safety of Adenovirus Vector lots through a series of rigorous assays and tests.