Due to its immense adaptability, extrusion has been widely utilized in diverse fields. Recently it is being adopted by the pharmaceutical industry at an unprecedented pace to address various drug product formulation and manufacturing needs. Learn more about this exciting yet complex technology and the many advantages it offers.
Understanding and being able to control granulation is essential to the production of high-quality pharmaceuticals. There are various methods through which granulation can be achieved. That which is chosen requires a thorough understanding of the physicochemical properties of the drug in addition to the characteristics of any pharmaceutical excipients.
Customers choosing to partner with a trusted CDMO for drug development and manufacture can benefit from an established quality policy addressing management responsibilities, risk management, documentation, change management, CAPA, process performance, and product quality. Leveraging the expertise of a CDMO to assure product safety is a proven approach to product realization.
The potential for antibody-drug conjugate (ADC) programs to accelerate from early-stage to late-stage clinical development highlights the need to establish commercial launch-ready manufacturing early and efficiently. Reduced time-to-market is key to deliver urgently needed therapeutics to patients, as well as to secure commercial success and maximize return on investment.
Scale-up and technology transfer of lyophilization processes remain a challenge. Learn how advances in steady-state computer modeling and bench-scale lyophilization practices are driving process optimization with minimal drug substances.
Antibody-drug conjugates (ADCs) are an important, emerging class of biologics that exploit antibody specificity to achieve targeted delivery of a small molecule drug. To reduce the risk of manufacturing failures and regulatory delays, it is sensible to partner with a CMO offering a strong biologics foundation when developing and manufacturing ADCs.