09.24.26 -- Dr. Heidi Overton And The FDA: An Outsourcing Perspective

Uncover how AI-powered modeling uncovers hidden patterns in DEL data, broadens chemical diversity, and accelerates decision-making to help teams prioritize compounds and move more efficiently.

Transform undocumented facility space into a dynamic digital model. Accelerate expansion planning, streamline vendor alignment, and optimize process flows with verified spatial data.

Integrated manufacturing ecosystems help biologics programs adapt to changing demand across the product lifecycle. Discover flexible scaling strategies that improve speed, efficiency, and sustainability.

Prepare for the upcoming USP <788> revisions by strengthening your particulate control strategy to support regulatory compliance, product quality, and patient safety across injectable drug products.

Particle counts don’t manage risk. Biologics need particle ID and forensic insight to separate benign artifacts from real threats and guide early decisions.

Integrated stable expression strategies accelerate biologics material generation, improving scalability, consistency, and early developability insights while reducing bottlenecks, variability, and risks.

Manage nitrosamines proactively by addressing drug substance impurities and excipient nitrite variability through product-specific testing and raw material screening.

Complex biologics development increasingly relies on knowledge-driven strategies combining platform methods, targeted customization, and high-throughput experimentation to accelerate IND readiness.

Integrating quality early in biopharma development reduces risk, speeds commercialization, and ensures compliance through inspection readiness and ongoing analytical oversight.

ADC developability assessment catches safety, functionality, and manufacturability liabilities before CMC — reducing costly late-stage failures. Access the full poster to see the assay framework in action.

Personalized cancer vaccines are advancing quickly, but effective delivery remains a major hurdle. Learn how mRNA and lipid nanoparticle design influence targeting, endosomal escape, and repeat dosing.

As pipelines grow more complex and timelines become more ambitious, companies increasingly rely on strong external partners to advance their drug products efficiently and with reduced risk. 

Aseptic powder filling is complex, demanding automation and isolator‑based, weight‑controlled dosing to ensure sterility and accuracy.

Specialized cell collection services depend on access to a large, diverse donor pool as well as robust donor screening and efficient collection practices.

Here, we describe the use of whole genome sequencing to perform a comprehensive assessment of genetic stability in clonally derived CHO cell banks using a genetic stability assay.

Advances in genetic disease research have strengthened the case for antisense oligonucleotides, offering a targeted way to correct faulty protein expression through nontraditional therapeutic approaches.