03.11.25 -- The Intelligent CDMO: A Vision With Agentic AI

As rare disease research continues to evolve, particularly with breakthroughs in precision medicine, the partnership between patient communities and biotech companies has never been more important.

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.

Revolutionize advanced therapy logistics by prioritizing patient impact at every step of the supply chain to ensure life-saving treatments are delivered with integrity and precision.

Technology transfer, the transmission of bioprocess knowledge, skills and technology, is a crucial mechanism for ensuring adequate and timely access to innovative medicines.

In this study, we developed a proprietary clonal suspension-adapted HEK293 cell line (AC001.230) through clonal isolation and high-throughput screening, resulting in improved productivity.

Producing mRNA therapeutics requires navigating complex manufacturing challenges. A strategic partnership with an integrated CMO streamlines manufacturing processes and reduces costs.

Ensure the safety and efficacy of lentiviral-based therapies by addressing the risks of replication-competent lentiviruses (RCLs) through advanced monitoring and control strategies.

Uncover how our collaborative approach positions us as an extended workbench for our partners, enabling faster, more effective solutions for patients.

Review the demands for AAV manufacturing using a suspension process and the DOE-based strategy used to achieve a scalable process both in terms production and quality of AAV purified.

This HEK293-derived, animal component-free suspension cell line forms the foundation of a scalable, robust platform process that accelerates AAV manufacturing.

Discover the efficiency of form fill and seal bags — ideal for all industries packing bulky or delicate products — with custom label applicators that integrate into high-output packaging machines.

Scaling up viral vector production can be challenging, and ensuring consistent titers and activity requires careful optimization and technical expertise.

This article recaps the significant FDA regulatory considerations for cell and gene therapies in 2024. Will 2025 see a continuation of these efforts?

Katie Jorgensen introduces BaseCamp's path to commercial readiness, highlighting key strategies for scaling from clinical to commercial manufacturing, with a focus on staffing, training, and preparation.

Committed to collaboration, Comprehensive Cell Solutions (CCS) combines the technology, expertise, and capacity you need to bring your novel cell therapies from discovery to commercialization.

Xcite AAV platform technology is established based on our proprietary suspension HEK293 cell line and plasmid vectors, proven to enhance AAV production.

Accelerate your drug discovery and development process by leveraging comprehensive quality insights for faster and more effective results.

As a full-service CDMO and bio-logistics provider, we deliver end-to-end solutions across the entire value chain, supporting the production, distribution, and delivery of cutting-edge cell and gene therapies.