Pharmaceutical Technology - May 2022

Pharmaceutical Technology- May 2022

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50 Pharmaceutical Technology TRENDS IN MANUFACTURING 2022 eBOOK P h a r mTe c h . c o m Aseptic Processing between grades of areas. Mobile robots are not currently able to move freely around pharmaceutical facilities due to the manual operation of airlocks between different grades. This problem needs to be solved in order to facilitate their introduction. • Milestone 3: Mobile sample taking. Mobile manipulator technology has been developing at a significant pace, and it is the BPOG teams' opinion that this technology will be available by 2024. • Milestone 4: Engagement with suppliers. Fol- lowing the completion of milestone 1, the in- dustry can engage with suppliers regarding the need to provide robot-friendly packaging. The aim is also to reduce packaging waste. • Milestone 5: Prototype QC lab with plug-and- play mobile robots. Integration of mobile ro- bots into a biologics QC lab could be very ex- pensive. If, however, the mobile/static robots are preconfigured for the equipment, then the installation cost would drop significantly. • Milestone 6: Fully automated packaging facil- ity from goods in, to goods out. The BPOG team believes that by 2027/28 the industry could have a packaging facility capable of being run from a control room. • Milestone 7: A fully automated inoculum lab- oratory. A project is underway to fully auto- mate the inoculum lab; full automation of grade A environments for handling cells is also required in cell and gene therapy appli- cations. Making the unit small and modular would be a distinct advantage. • Milestone 8: Fully automated cell therapy fa- cilities from goods in, to goods out. Cell ther- apy represents a significant change for the pharmaceutical industry, making this mile- stone the most challenging to achieve but also most important. Although the cost of producing these new modalities is significant, automation can reduce production costs. The BPOG roadmap lays out a plan for achiev- ing a lights-out, fully automated facility, begin- ning with packaging operations and working up to a complete cell therapy facility by 2029. All parts of the industry must work together to achieve these goals. References 1. EC, Draft Revision to "Annex 1, Manufacture of Sterile Medicinal Products," (Brussels, 2020). 2. BioPhorum, "Robotics Biomanufacturing Roadmap, Draft Version 1," presentation at the Pharmaceutical Mobile Robotics Conference (London, UK, April 21-22, 2022). PT Pharmaceutical Technology presents the Drug Solutions Podcast, where the editors chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest questions—from the technologies, to strategies, to regulations related to the development and manufacture of drug products. In this episode of the Drug Solutions Podcast, Jennifer Markarian, manufacturing reporter, talks about continuous manufacturing of oral solid-dosage drugs with Lawrence De Belder, executive consultant at Pharmatech Associates, a USP company. This discussion looks at some of the challenges facing broader industry adoption of continuous manufacturing, how process analytical technology data can be used for process control or for real-time release, and how implementation of continuous manufacturing approaches is evolving. Click HERE to listen to the podcast. —The editors of Pharmaceutical Technology Drug Solutions Podcast: Drug Manufacturing Technology

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