12.01.25 -- AI Assesses Passion At CDMOs, But Humans Think Differently

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.

With increased pressure on CMC development to support shortened BLA submission timelines, mass spectrometry (MS) can be leveraged to accelerate and de-risk product and process development.

Sterile injectable success depends on early CDMO partnerships. The right fill-finish partner will be able to transform development challenges into efficient, patient-centered commercial success.

Struggling with missing logbooks or tedious cleanroom reviews? Discover how electronic logbooks streamline compliance, boost efficiency, and unlock insights to transform operations.

Ongoing process verification has evolved beyond a compliance exercise to a strategic priority thanks, in part, to technology advancements.

Technology can transform the entire biopharma production process chain. Using integrated process models, machine learning, and genetic algorithms has made production faster and more efficient.

See how a successful collaboration led to the design of novel, cell-permeable maytansine-based payloads for antibody-drug conjugates to enhance the critical "bystander killer effect."

By partnering with a trusted company that offers expertise in navigating the challenges of scale up, drug developers can have confidence in their ability to successfully bring their products to market.

Integrated analytical capabilities within a CDMO are increasingly preferred to overcome challenges associated with outsourcing analysis in biopharma development and manufacturing.

Observe how integrated project management and co-located DS/DP operations streamline technology transfer, reduce risks, and accelerate biopharmaceutical development timelines.

To ensure speed and stability in the manufacture of your complex biologic — mAbs, antibodies, fusion proteins, and/or antibody drug conjugates — prioritize a high-performance CLD workflow.

Consider how our efficient strategies can propel your monoclonal antibodies (mAbs) from discovery to clinical manufacturing in as little as 18 months.

By integrating sustainability into every step, we help our partners achieve their environmental goals while maintaining the reliability and quality needed to ensure timely access to therapies.

Get real-time viable environmental monitoring with contamination control strategies, no glass-to-glass contact, 100% fully automated inspection, electronic batch records, and more.

Leverage advanced isolator-based fill-finish capabilities to achieve precise, efficient, and flexible sterile manufacturing for biologics, small molecules, vaccines, and other complex formulations.

From start to finish, NovaPure components have been designed and manufactured using Quality by Design principles to mitigate risk for the patient.

This presentation highlights how simplified execution with development, filling, and analytics under one roof ensures safe, efficacious products reach patients in need.

Using deep ADC expertise and experience, we successfully develop high quality, commercially viable processes, spanning from pre-clinical development through commercial scale manufacturing.