A review of several “small changes” that are pieces of the supply chain puzzle and can wreak havoc if not planned for in advance.
To address the ongoing public health crisis related to opioid abuse, Xtampza® ER, an oral ER abuse-deterrent formulation of oxycodone, has been developed to resist the ability of abusers to tamper with the product and alter the route of administration.
- Clinical trial sponsors and clinical supply vendors must fully consider all attributes of their supply chains to ensure continuity of supply post-Brexit. This whitepaper outlines many questions that sponsors and vendors alike should ask
By recognizing the limitations of today’s production processes, the industry may be able to overcome the challenges, complexity, and high cost of manufacturing vaccines and viral vector-based therapies.
Engaging clinical supply management and forecasting adds value by evaluating different response strategies and contingency plans and can identify supply solutions that minimize or even potentially avoid supply chain disruptions.
The ADC field is in a transitional period. Older approaches to conjugate composition and dosing regimens still dominate the ADC clinical pipeline, but preclinical work is driving a rapid evolution in how we strategize to improve efficacy and reduce toxicity towards better therapeutic outcomes. In an indication of future directions for the field, antibody conjugates bearing non-cytotoxic small molecule payloads are being developed to reduce side effects associated with treatment of chronic diseases.
The importance of optimizing the chemical synthesis and formulation processes in complex molecule development.
Learn how a structured 3-step approach can help overcome the challenge of molecular characterization and a limited budget.
Smart bioprocessing uses bioinformatics, lab-scale processing, and analytics to create efficient and cost-effective production processes that can be verified at lab-scale before scale-up.
Read how this method resulted in higher purity and yield than what can be expected from a purification process based on salt precipitations and sucrose gradient centrifugation.
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