Automation: Revolutionizing Process Development

Key points:

  • Automation is being increasingly used in the biopharmaceutical industry for process development
  • Automation brings reproducibility and throughput to biopharmaceutical processes
  • Automation is particularly important for generating contextualized data, which is required for FDA submission
  • There is a growing demand for automation in the biopharmaceutical industry, as companies seek to increase efficiency and utilize advanced digital methodologies
  • Automation is also being used in the development of personalized, patient-specific therapies

Traditional biopharmaceutical process development relies on experimentation, with scientists conducting hundreds of separate studies and assays to understand the impact of process parameters on the finished product. However, there is a growing trend towards automation in this field, as companies seek to increase efficiency and generate large datasets of high quality.

Automation brings reproducibility and throughput to biopharmaceutical processes. It allows companies to generate more data of higher quality in a shorter period of time, which is particularly important for biopharmaceutical companies that need to submit highly contextualized data to the FDA for regulatory approval.

There is a growing demand for automation in the biopharmaceutical industry. Some companies see it as a way to increase efficiency and utilize their equipment and space more effectively. Others view it as a foundation for the adoption of more advanced digital methodologies, such as artificial intelligence.

Automation is not limited to companies that produce mass market products. Developers of personalized, patient-specific therapies are also starting to automate processes, particularly in the QC (quality control) of prepared therapies. This type of automation is part of the manufacturing process and requires a more regulated approach.

In conclusion, automation is becoming increasingly important in the biopharmaceutical industry. It brings reproducibility and throughput to process development, allowing companies to generate more data of higher quality in a shorter period of time. Automation is also important for personalized, patient-specific therapies, particularly in the QC of prepared therapies. Overall, there is a growing demand for automation in the biopharmaceutical industry as companies seek to increase efficiency and utilize advanced digital methodologies.