Protein-based therapeutics have emerged as a key driver of growth in the pharmaceutical industry. R&D pipelines have filled with biologics and monoclonal antibodies have become the best-selling drugs around the world. Despite the success of this segment, the size and complexity of protein molecules create specific challenges when developing these types of therapeutics.
Use of recombinant proteins as therapeutics has become an attractive strategy for altering the biology of disease progression and offers significant commercial opportunities. However, bringing a recombinant protein to market requires a substantial investment of time and resources, and the process is generally complex and subject to technical pitfalls.
The pharmaceutical industry lags in the sophistication and performance of its supply chains when they are compared with best-in-class companies in other industries. This is due to the complexity that has come with new drugs, more complex production technologies and evolving regulatory requirements. In this environment, integrating and aligning the supply chain makes it more flexible, bolstering operational performance and financial competitiveness.
Supply chain management has advanced rapidly over the past decade, evolving from what was once dubbed “materials management” into the essential glue that binds all aspects of a business’ internal and external collaborations.
The changes in the economic landscape and pipelines over the last 10-15 years have resulted in drug developers in companies of all sizes to take a hard look at their strategy and operations.
Newron Pharmaceuticals S.p.A. (“Newron”), a research and development company focused on novel CNS and pain therapies, and its partners Zambon S.p.A. and US WorldMeds announced recently that a complete response letter from the FDA has been received for safinamide