A niche CDMO, with specialized technologies in complex injectable development, will have greater flexibility for successful manufacture of complex injectables in early phase development of therapeutic drugs.
Understanding the properties of ASDs and their relationship to the downstream product scale up, stability, and in-vivo performance is critical to successfully utilize them for drug delivery of insoluble drugs.
Many initially promising biotherapeutic candidates fail due to lack of efficacy or safety, but there are candidates that fail due to stability, aggregation, and other issues related to cell line or process issues.
Designing patient-centric programs can have a resoundingly positive impact on clinical research and the health and life of patients. Consider six ways to "reverse engineer" development strategy to accommodate the true rare disease patient journey.
Determining bioavailable formulation for animal PK, GLP toxicity, first-in-human, and first-in-patient is challenging. Drug delivery systems are usually used for poorly soluble and bioavailable compounds.
Delivery system manufacturers need to manage conflicting requirements and offer delivery solutions that balance performance, robustness, and usability while delivering higher volume or viscosity biologics.