06.10.25 -- A Case For Paying Allogeneic Cell Therapy Product Donors

By analyzing patient data sets, AI enhances predictive analytics, supports real-time patient alerts, and strengthens continuous monitoring — improving the effectiveness of clinical trial oversight.

Review strategies that can help build an understanding of risk assessment, in addition to how a study’s protocol requirements, packaging specifications, and more must be identified and addressed.

Learn about a key biomarker for CYP3A activity. This derivatization-free method offers a faster and more efficient approach for clinical studies.

A Takeda production site in Linz, Austria, received an ISPE’s 2024 Facility of The Year Award. What’s so special about that location? The explanation from Roland Fabris, Site Head, will actually help you benchmark your CDMO, and demonstrate much about facility selection applicable to your own outsourcing needs. 

Here, we see how this workflow was able to overcome obstacles that were encountered and successfully completed during process development for manufacturing adenovirus vectors.

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

As sponsors strive to deliver therapies with increasing efficiency, CDMOs are poised to remain vital, offering specialized expertise, accelerated timelines, cost efficiency, and risk mitigation.

Leverage cGMP expertise in cell therapy manufacturing, from primary tissue processing to large-scale production for clinical trials.

Uncover the secrets behind successes in commercializing and producing commercial cell and gene therapies, including establishing standards of every day, manufacturing operational excellence.

Using cells with a pre-engineered landing pad,  achieve inducible expression within just 4-6 weeks after donor plasmid creation, significantly reducing development time and effort.

The effectiveness of cell-based therapies hinges on preserving cell viability, stability, and consistency. However, inconsistencies in cryopreservation methods have undermined therapeutic success.

Through this comprehensive analysis, we demonstrate how to accelerate development timelines, support compliance, and ultimately strengthen the customer’s business.

Pharmaceutical labeling demands precision. Examine key considerations for ensuring accuracy and efficiency in your process, from robust control systems to diverse printing options.

Discover how advanced plasmid manufacturing and AAVion® platform can drive your AAV program forward by reducing production costs while maximizing efficiency.

Polymerase delivers enhanced safety, cost-effectiveness, and performance, empowering researchers to unlock the full potential of mRNA therapeutics.

Explore comprehensive services tailored to meet your needs from a company with proven expertise in viral clearance. Choose from four global locations and three service packages.

By combining disruptive technology platforms with unparalleled genomic medicine development expertise, the development of LNP formulations and drug products is being accelerated.

Focusing on critical parameters such as cell culture conditions, viral vector yield, and downstream purification strategies, can drive the success of scale-up and scale-down models for AAV production.

An update on our Philadelphia campus: comprehensive CGT services, from discovery to clinical production, with integrated bioanalytical testing to streamline timelines and reduce risks.