Single use products in biopharmaceuticals reduces in-house sterilization requirements and enables manufacturers to avoid sterile equipment

 

Single use products in biopharmaceuticals

The U.S. Food and Drug Administration has recently released its Medical Countermeasures Initiative for Advanced Manufacturing. This initiative calls for biopharmaceutical manufacturers to accelerate their research and development efforts through the use of rapid-scale manufacturing, shortened processing steps, and personalized medicine.

The Global Single Use Products in Biopharmaceuticals Market is estimated to be valued at US$ 1,821.2 Mn in 2021 and is expected to exhibit a CAGR of 16.7% over the forecast period (2021-2028). 

The introduction of single use products in biopharmaceuticals came about a decade ago. Initially, single-use manufacturers had to extol their benefits and virtues. Today, with the increasing diversity and cost of biopharmaceutical products, more bioprocessing companies have begun to incorporate this technology. Single-use products are not limited to biopharmaceuticals but can be used for many types of products.

These products can be grouped into different systems, including those used in the everyday lab. These systems are made for basic operations, process platforms, and formulation. The Allegro Single Use platform is unique in its approach and enables scale-up without compromising reliability and robustness. The Allegro single-use platform provides a comprehensive set of solutions to all these issues while providing the benefits of a scalable, standardized platform. Before becoming mainstream, single-use drug packaging was frowned upon by the biopharmaceutical industry. Its popularity was tempered by a number of concerns, including cost, validation complexity, regulatory reliability, and potential leachables. The concept of single-use products was initially viewed as an interesting concept for process development but not a viable commercial manufacturing option. However, with the help of new technologies, single-use products have made significant progress.

The use of single-use technologies reduces in-house sterilization requirements and enables manufacturers to avoid sterile equipment. Single-use technology reduces the need for cleaning between batches, reducing costs and promoting sustainability. The single-use systems require less cleaning, reducing downtime, and maximizing efficiency. They also eliminate the risk of cross-contamination between batches. The benefits of SUT are numerous.