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

Review additional details on the FDA expedited review programs, the incentives for obtaining such designations, and the required information/data needed to better position products in development.

As AI and machine learning (ML) enter the drug manufacturing toolkit, sponsors are exploring how these technologies can improve process chemistry and develop scalable synthetic routes.

A new approach to Liquid Phase Peptide Synthesis (LPPS) leverages traditional batch reactors alongside continuous flow technology, allowing for more efficient and sustainable processes.

Despite tight restrictions, patchwork regulations, and an unclear timeline, one researcher says we're heading toward fully-digitalized drug labels.

While various frameworks exist for evaluating chemical and process safety, a science-based approach is essential. Without it, organizations risk missing crucial details that can hinder operational success.

Spray drying of amorphous dispersions improves solubility and bioavailability, enabling supersaturation in the intestine and driving higher absorption rates when compared to crystalline drug forms.

Integration of robotics and automated systems across laboratory services significantly decreases experimental timelines, tightens precision, and enhances scientists' capacity for critical thinking.

Although well-established processes, spray drying and hot-melt extrusion can be outperformed in bioavailability, cost-savings, manufacturing speed, environmental impact, and more.

Our network currently spans nine manufacturing sites in five countries and can support discovery, preclinical, clinical, and commercial programs for New Chemical Entities (NCEs).

With cutting-edge capabilities and client-focused solutions, we help move your drug from concept to commercialization, bringing transformative therapies to patients with speed and quality.

Achieve commercial readiness with flexible, compliant, and scalable manufacturing for solid oral dosage forms and high-potency products across global markets and niche indications.

With an estimated 90% of organic molecules exhibiting multiple forms (polymorphs and pseudopolymorphs), the selection of a lead solid form is a critical early step in development.