12.08.25 -- 2025 Review: Customer Service As Important As Capacity And Capability

Discover how KBI Biopharma scientists used advanced mass spectrometry and cutting-edge analytics to solve real-world manufacturing challenges and prevent costly setbacks. Through two powerful case studies, you’ll see how peptide mapping and LC-MS analytics uncovered hidden impurities and degradation issues before they derailed development—proving that early analytical investment can safeguard your product quality, timeline, and bottom line. Click here to learn more.

Find out why it is critical that OEMs see and understand the benefits of taking time to build a mold or create automation more robustly to achieve long-term savings and higher annual production.

BD Physioject™ for Tirzepatide supports FDA ANDA submissions with proven usability, low error rates, and a design validated to match the reference listed autoinjector.

Explore guidance regarding the effective validation of a virus filtration process in the laboratory, including the fundamentals of viral filtration and an examination of relevant regulatory guidelines.

Information now flows faster than organizations can think about it, and without deliberate structure, decision-making becomes reactive rather than reflective.

Through case studies and practical insights spanning complex drug substance and drug products like ADCs, learn more about navigating complexities with integrated regulatory services and guidance.

Single-use technologies (SUTs) bring speed and flexibility to modern biomanufacturing, but realizing their full value requires risk management to navigate material, supply chain, and regulatory challenges.

As the digital backbone for real-time production control and data integrity, see how a manufacturing execution system (MES) orchestrates production processes from start to finish.

Review the pros and cons of soluble and insoluble processes, experiences with isolating, solubilizing, and properly re-folding, and strategies and innovation to improve insoluble processes.

Uncover the results collected when a platform designed with ML-guided GPS engineering was applied to develop a lead molecule targeting a mechanism in neuronal disease.

Boost your upstream and downstream processes and decrease the timeline from optimization to commercial manufacturing without sacrificing the thorough scientific evaluation of the process.

Our multi-product manufacturing facilities feature state-of-the-art equipment for animal cell-derived viral and microbial products for your clinical trials in phases 1-2, in accordance with cGMP guidelines.

This session provides a comprehensive overview of our biopharmaceutical contract manufacturing services for mammalian cell culture and microbial technologies.

Find more than just reliable, flexible support along the entire value chain of injectables. Learn how dual-site EU-based operations provide scalable capacity and seamless global supply for your molecules.

Advance your biotherapeutic with a trusted global CDMO partner offering end-to-end development and manufacturing, supported by state-of-the-art facilities and a commitment to your success.

Unearth how proprietary cell lines enhance development, reduce costs, and accelerate market entry with built-in regulatory support and extensive expertise in adherent cell culture.

Partner with a U.S.-based, trusted CDMO large enough to support every stage of your program, yet agile enough to deliver the dedicated care your project deserves.