The use of production scale, single-use bioreactors for cGMP manufacturing is now an accepted option for production of clinical and even commercial biopharmaceutical products. Early adapters are now routinely using 1,000 – 2,000 L single-use bioreactors to manufacture biopharmaceuticals for use in multiple countries worldwide.
As outlined in this whitepaper, single-use bioreactors are being utilized to both add cGMP capacity to existing facilities and to construct new facilities in a rapid and cost effective manner.
CMOs and product companies that are operating multi-product mammalian cell culture facilities are especially benefiting from the increased acceptance and availability of production scale single-use bioreactors since one of the major advantages of this technology is reduced changeover and cleaning time between batches. Companies who have embraced this technology are positioned to address the emerging business
challenges associated with expanding and changing global biopharmaceutical landscape.
Download BPTC’s whitepaper now to learn more on:
- How smaller production bioreactors can meet demand for new products
- Implementing single-use technologies for biomanufacturing
- The use of production scale single-use bioreactors in cGMP manufacturing
- Benefits of single-use bioreactors for cGMP manufacturing
- Process portability
BPTC is the world leader in providing strategic, technical, and regulatory consulting services to the biopharmaceutical industry, specializing in all aspects of process development and manufacturing. BPTC’s team of committed, knowledgeable consultants have hands-on experience and technical expertise in the development, manufacture, quality control, and quality assurance of biopharmaceutical products and understand first-hand the challenges of developing and commercializing new products and technologies.
The Cell Culture World Congress USA is North America’s premier meeting place for biopharma, biotech, academia and the FDA to talk about upstream cell culture optimization. The conference showcases the latest trends in continuous process development, automation, 3D cell culture and big pharma adoption of single-use disposable technologies for large-scale manufacturing.