Executive Summary
The entry of the 5,000L single-use bioreactor (SUB) into biologics manufacturing is providing an important bridge between small-scale and large-scale production. This new choice offers biotech and pharma companies, as well as CDMOs, more flexibility than ever before to respond to fluctuations in demand quickly and efficiently.
As the market for complex biologics continues to grow, effective capacity planning becomes more important – and more challenging.
• This report offers a guide for biopharmaceutical innovators on evaluating capacity needs and the advantages of using SUBs at each stage of development.
• Topics include:
• Features and benefits of 5,000L SUBs • How improvements to turndown ratio, oxygen transfer rate, and more with SUBs provide a more efficient and flexible biologics development ecosystem and help accelerate scale-up and time to market
• Efficiency and sustainability advantages that SUBs offer over stainless-steel bioreactors, helping to accelerate time to market for biologics manufacturing and lowering carbon footprint
• What to look for in a CDMO partner for manufacturing with SUBs to ensure reliability, flexibility and collaboration
Introduction: Understanding the Importance of Capacity
The market for complex biologics including monoclonal antibodies, bispecific antibodies and fusion molecules is growing at a rapid pace. Recent estimates suggest the global market for monoclonal antibodies will grow 11% annually to reach nearly $500 billion in 2030.1 The global market for fusion proteins is expected to grow 4% a year to $33 billion in 2030, and the market for bispecific antibodies is projected to expand at a rapid 43% per year to $110 billion in that time period.2,3 This unprecedented growth is increasing the pressure on biopharma developers and their partners to improve efficiencies at every stage of the manufacturing process. Ensuring that the correct manufacturing capacity is in place for a new biologic is an essential part of that process.
Capacity planning, however, is challenging. Predicting future demand for a novel therapy that’s still in clinical development requires significant guesswork, as well as contingency planning in case projections are either too high or too low. Supply and demand for marketed biologics can fluctuate, requiring that therapeutics manufacturers and CDMOs have the capacity to scale production up or down flexibly and efficiently.
The ability to quickly scale up capacity based on demand significantly impacts cost efficiency, potentially lowering costs per unit. What’s more, effective capacity planning can shorten the time to market for new biologic drugs. That gives developers a competitive advantage as they aim to speed patient access to new biologics.
