Digital Bioprocessing Technologies to Boost Drug Makers’ Product Quality and Reduce Costs, Says Expert
According to industry expert Karlheinz Landauer, digital bioprocessing technologies have the potential to greatly improve drug makers’ product quality, while simultaneously reducing manufacturing costs. Landauer notes that the combination of quality-by-design (QbD) and digital technologies offers numerous advantages to the drug industry.
QbD is a principle that focuses on building product quality into manufacturing processes from the earliest stages, rather than relying solely on testing after process development is completed. The drug industry has been exploring QbD since the 1980s, driven by regulatory requirements for “high-quality” medicines. In 2009, the FDA introduced its first QbD guidance document and began encouraging manufacturers to adopt the approach.
While many in the industry have embraced QbD, Landauer emphasizes that developing a commercial-scale production process using QbD remains a challenging task. It requires full characterization of the process or process step, understanding its effects on the target molecule, and performing extensive experiments and analytical tests. This can be costly and time-consuming, making it difficult to implement the full QbD approach.
However, Landauer believes that the emergence of innovative methods and digital bioprocessing technologies that enable real-time capture, transmission, and modeling of process data will simplify and streamline QbD-based process development. He stresses the importance of advanced analytical technology in evaluating, predicting, and modeling the biopharmaceutical process.
Landauer also highlights the potential cost-saving benefits of digital technologies in commercial manufacturing. With digital technologies, minor adjustments to processes could be made without extensive regulatory notifications. Currently, manufacturers must inform multiple regulators in different countries before implementing any process changes. This process can be time-consuming and burdensome, especially for international drug companies.
In conclusion, the integration of QbD and digital technologies holds promise for drug makers, offering improved product quality, reduced manufacturing costs, and streamlined regulatory processes. Landauer encourages the industry to embrace these advancements to fully leverage the benefits they offer.
Analyst comment
Positive news: Digital bioprocessing technologies have the potential to enhance drug makers’ product quality and reduce manufacturing costs, according to expert Karlheinz Landauer. The integration of quality-by-design (QbD) principles and digital technologies can simplify process development and improve regulatory efficiency. This advancement is expected to benefit drug makers by improving product quality, reducing costs, and streamlining regulatory processes.
