May, 22, Sunday, CBA and its CCRA group lit on the summer heat with a hotter-than-ever webinar on 3D Printings in Pharmaceutical Development: History, Current Landscape, and the Future. This webinar brought together the leading experts and forerunners on Pharmaceutical 3D printing from the US, Europe, and China.
The webinar started with warm welcome from the current CBA Vice President/CCRA Group Lead Dr. Angela Zeng. She then introduced the history, mission, and past/current activities of CBA/ CCRA and encouraged interested attendees to join the group.
Professor Xiaoling Li kicked off the lecture with his talk entitled “Melt Extrusion Deposition (MED) 3D Printing: An emerging Technology for Pharmaceutical Applications”. He first gave an overview of different technologies currently employed in 3D printing of pharmaceuticals. He further elaborated the technical details of MED and its advantage and utilization in precise control of drug release profiles. He concluded his talk with a few case studies from his company, which received FDA IND clearance (or in the process) to test in clinical studies. Dr. Li is the chief scientific officer and co-founder of Triastek. With decades of experience in drug delivery, Dr. Li also holds the tenure as Professor in the School of Pharmacy at the University of the Pacific.
Dr. Alvaro Goyanes Goyanes, the CEO and co-founder of FabRx and honorary lecturer at the University College London (UK) and University of Santiago de Compostela (Spain) pitched his talk, entitled “3D Printing of Personalized Medicines” from a different perspective and focused on the advantages of 3D printing in the field of personalized medicines. In his talk, Dr. Goyanes demonstrated the 3D printing platform M3DIMAKER™ and how it was used to create personalized medicines to assistant the needs from special populations such as pediatric patients and cancer patients. He further discussed about the pros and cons of personalized medicine in a pharmacy/clinical setting.
The last lecture was given Dr. Michael Gosselin, the VP of Pharmaceutical Development at Aprecia, USA. Dr. Gosselin, with years of experience in pharmaceutical development and manufacturing operations, shared with the audience the story behind Spritam® at Aprecia, the first ever 3D printed tablet approved by the FDA. He further introduced how the 3 product platforms (Open Bed ZipDose, In-Blister ZipDose and Open Bed ZipCup)- are being used to leveragefor novel dosage forms at Aprecia. Dr. Gosselin concluded his talk with a brief introduction of next generation of 3D-printing process and system.
The talks were well received and elicited a heated round of questions, comments, and discussions among the speakers and panelists including former FDA reviewer, current 3D-Medicine COO Dr. Shen Xiao, and BLA Regulatory Founder and Chief Consultant, Dr. Frank Li. Dr. Angela Zeng led the discussion and speakers addressed questions from audience. Specifically, the experts discussed the technical challenges and regulatory pathways for 3D printing, the differences and similarity of regulatory strategy in Europe and the US. Questions from audience also covered details on the API, the possibility of applying 3D-printing to any mAb or mRNA product, the efficiency of 3D-printing technology in manufacturing etc.
The committee concluded the webinar with addressing the advantages and disadvantages of 3D-printing technology when comparing with conventional manufacturing methods, then acknowledged those difficulties and solutions within the technology itself and challenges lie in future directions to bring the new process to the regulatory approval. Post-meeting feedback from attendees stated this seminar is of pharmaceutical professionals’ interest and has demonstrated the scientific vision and attitude of CBA.