06.20.19 -- Single-Use Manufacturing Redefined From A-Z
The Foundations For Single-Use Manufacturing.
Redefined From A To Z.
In the past, biopharma companies struggled with a variety of risk factors that kept them from fully considering and implementing single-use solutions.
Weighing these risk factors and solving these challenges simultaneously proves difficult and requires a strategy that considers biocompatibility, integrity control, and testing, along with an automation platform and supply network.
The below articles discuss this strategy and how it can provide flexibility and acceleration to market while also ensuring the quality of your biologics and enhancing your patient safety.
The loss of patent protection from blockbuster drugs is creating a market for biosimilars in which being able to compete effectively requires low prices underpinned by low manufacturing costs. Enhanced flexibility and reduced operating costs are being achieved through the widespread adoption of single-use technology, either as part of completely single-use processes or as hybrid solutions.
Biopharmaceutical R&D teams everywhere face the same dilemma in the development of biologics and vaccines: they must increase productivity to meet strict budgets and deadlines, while maintaining or improving data accuracy. In order to meet market demands, biopharmaceutical companies are increasingly turning to bioreactor technology that allows for high-throughput process development and optimization for both microbial fermentations and cell culture processes.
The pipeline of biopharmaceutical drugs is rich and becoming increasingly diverse. Strategies need to be developed to prepare manufacturing facilities for these challenges. Single-use technologies have received considerable attention in recent years as a platform to tackle the multimodality manufacturing conundrum. These technologies can be used to reduce time to clinic and delay investment decisions as well as allow a high degree of operational flexibility.
Single-use bioreactors are widely accepted in the pharmaceutical industry and are increasingly being used to perform mammalian cell cultures in commercial manufacturing applications. They address some of the key challenges the industry faces by decreasing time-to-market, reducing validation efforts, increasing flexibility, reducing investment costs, and optimizing cost of goods.