🧪 New technologies like continuous processing and cleavable tags can lower capital investment and manufacturing footprint.
⚠️ However, there are risks, as demonstrating bioequivalence to the original product may require expensive clinical trials.
🔬 Companies producing complex glycoproteins face challenges in adopting new technologies due to matching requirements.
💡 Technologies like single-use disposables and alternative expression hosts can benefit simpler biosimilars.
🔑 Protein Capture Science provides self-removing affinity tags that reduce the number of chromatography columns needed.
🌍 Increasing access to biosimilars in developing countries is a priority.
Introduction:
Biosimilar manufacturers are seeking more efficient technologies to reduce costs and increase drug availability. Traditional processes using batch processes and chromatography are still widely used, but new technologies such as continuous processing, cleavable tags, and different expression systems have the potential to lower capital investment and manufacturing footprint for biosimilars. However, adopting novel technologies poses challenges, especially for complex glycoproteins that need to match the glycosylation profile of the original product. Despite the risks, these new technologies offer cost-saving opportunities for biosimilar manufacturers.
- Biosimilar manufacturers often use legacy processes for regulatory submissions, but new technologies have the potential to reduce costs.
- Companies producing complex glycoproteins face challenges in adopting new technologies due to the need to match the glycosylation profile of the original product.
- Single-use disposables and continuous processing can reduce upfront capital costs for simpler biosimilars.
- Self-removing affinity tags, such as those developed by Protein Capture Science, can simplify purification processes and reduce the number of chromatography columns needed.
- Other technologies, like alternative expression hosts and engineered proteases, also hold promise for more efficient biosimilar manufacturing.
Conclusion:
Biosimilar manufacturers are exploring more efficient technologies to reduce costs and increase drug availability. While there are challenges in adopting these novel technologies, they offer cost-saving opportunities for biosimilar production. Continuous processing, cleavable tags, and alternative expression systems are among the technologies being explored to lower capital investment and improve efficiency in biosimilar manufacturing.
