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

Enable precise, non-viral gene delivery and unlock new therapeutic directions in cancer, rare diseases, and personalized medicine through molecular and nanoparticle engineering advances.

Proactive, risk-based oversight must be established to manage outsourced GXP activities. This requires a robust QMS and comprehensive quality agreements to safeguard product quality and data integrity.

Review advice to pharma companies on three key areas of auto-injector device development: patient-centered design, container and device considerations, and manufacturing partner selection.

Both focus areas aim at the same outcome, stronger economics and sustainable competitiveness, according to BioPlan Associates' 22nd Annual Biomanufacturing Report.

By improving the granularity and interpretability of preclinical immunogenicity data, EpiScreen® 2.0 supports more confident lead selection and helps mitigate downstream clinical risks.

Lyophilization allows for the stabilization and storage of complex molecules, extending their shelf-life and availability to patients and ensuring this vital industry's success.

Conducted alongside the Faculty of Medicine at Palacky University and supported by the Technology Agency of the Czech Republic, this project translates research into a viable medicinal product.

Consider the following agile, expert CDMO services for injectable medicines, that combine technical excellence and near-term availability to accelerate development and manufacturing.

For many bioprocessing applications, artificial intelligence and machine learning can be used in every development phase to support optimization and streamline repetitive, effort-intensive processes.

Jin Lu, Ph.D., Senior Technical Support Manager, shares how novel expression tools can advance your early-stage bispecific antibody discovery programs toward clinical success.

Optimized input parameters like DBC, flow rate, and resin durability are key to boosting productivity in downstream bioprocessing. Discover how to tailor resin choices to meet specific process requirements.

Whether you aim to launch your innovative product on a global scale, enhance your formulation, or proactively manage risks, Simtra is here to support you in fulfilling your commitments to patients.

Experience a global network of expertise and proven manufacturing capabilities that can help accelerate your clinical and commercial drug substance programs.

Among the constantly growing market of biopharmaceuticals, monoclonal antibodies derived from mammalian cell culture account for a share of approximately 50%.

With the robot-assisted labeling cell 211R HC, HERMA shows how challenges in wrap-around labeling of label material can be solved more effectively. Discover the advantages of our HERMA 211R HC labeling solution.

As pressure to accelerate timelines mounts, finding a CDMO committed to increasing capacity and optimizing processes is key for adding efficiency while maintaining high-quality standards.

Learn how leveraging the expertise and flexibility of a partner empowers you to ensure regulatory compliance from the outset, with thorough characterization starting at the earliest stages.

Affinity is the driving force behind everything we do. It's reflected in our deep commitment to our clients, our dedicated teams, and ultimately, the patients who depend on life-changing therapies.