The Future of Pharmaceutical Manufacturing: Flexibility and Sustainability through Small Footprint, Modular Equipment Trains
10th October 2017 | 10 AM ET | Daniel O. Blackwood & Jeffrey Moriarty of Pfizer, Inc. |WATCH FOR FREE
Following a decade (or more) of concerted effort by industry, regulator, and academic groups, recent technology investments are now beginning to shape how medicines are being developed and manufactured for the global marketplace. While significant focus has highlighted the emergence of continuous manufacturing processes, three additional trends have also influenced and served as underlying drivers for these technology investments. First, the emergence of scientific advances in targeted biology has created high-value personalized medicines with smaller manufacturing volumes (doses/annum). Second, new regulatory pathways, such as the FDA’s Breakthrough Therapy designation, have accelerated the development and commercialization timelines for these new medicines. Finally, manufacturing localization has extended supply chain networks to serve globally-distributed patient populations throughout the world. Together, these drivers have served to shape the future of pharmaceutical development, manufacturing, and distribution of a variety of different dosage forms. The increasing need for product development speed and commercial supply flexibility through small-footprint, modular equipment trains will be highlighted within this paper, using an immediate-release solid oral dosage form example.
Presented by Daniel O. Blackwood & Jeffrey Moriarty of Pfizer, Inc.
Daniel is currently a Research Fellow in the Technology & Innovation group of Pharmaceutical Sciences- Small Molecule at Pfizer, based in Groton, Connecticut. Currently, he is the technical program lead for Pfizer’s Portable, Continuous, Miniature, and Modular (PCM&M) development and manufacturing initiative for Oral Solid Dosage (OSD). In this role, Daniel is leading the cross-functional team of engineers and scientists in the design, fabrication, and installation/commissioning activities for PCM&M. In addition, he is a subject matter expert in drug product continuous processing technologies including gravimetric feeders, in-line powder mixers, and tablet compression equipment. Daniel received his BS in Mechanical Engineering from Cornell University in Ithaca, NY and his MS in Industrial Engineering from Columbia University in New York City.
Jeffrey Moriarty is a Director in the Pharmaceutical Sciences Small Molecule division at Pfizer, Inc. in Groton, CT. He has 13 years of experience working in drug product development and currently leads the quality risk management program for Co-Development drug product small molecule programs. In this role, Jeffrey supports Knowledge Management and Quality by Design (QbD) activities and partners with project teams to create the process understanding necessary to develop well designed control strategies. He is also a subject matter expert in continuous manufacturing, utilizing Pfizer’s PCMM (Portable, Continuous, Miniaturized, Modular) oral solid dosage development and manufacturing system. Jeffrey has a B.S. and M.S. in Chemical Engineering from Villanova University.
Sponsored by G-CON Manufacturing Inc.
G-CON designs, produces and installs prefabricated, autonomous cleanroom PODs®. G-CON’s cleanroom POD® portfolio encompasses a variety of different dimensions and for multiple purposes, from aseptic fill/finish and laboratory environments to personalized medicine and production process platforms. The POD® cleanroom units are unique from traditional cleanroom structures due to the ease of scalability, mobility and the ability to repurpose once the production process reaches the end of its lifecycle.
Presented by Dennis Powers of G-CON Manufacturing Inc.
Dennis Powers is the Director of Sales Engineering for G-CON Manufacturing since 2013 and has over 20 years experience working in the biopharmaceutical industry on both the manufacturing and supplier sides of the business. He has held positions in various technical and management functions including engineering, quality and validation, project management, and operations. Through his career, Dennis has worked closely with numerous companies in the pharma and biopharma industry to provide process and facility solutions to meet their specific needs. He is an active member of the PDA and ISPE.
Dennis received his B.S. in Mechanical Engineering at the University of Delaware and his M.S. in Management from NYU Polytechnic University.
PODs: Helping to Define the Future of Pharmaceutical Manufacturing through Modular and Portable Cleanroom Facility Designs
With the development of new drug therapies and a changing global landscape, the traditional manufacturing and logistic models no longer adequately meet the demand and market needs for pharmaceutical drug products. Smaller, agile and more readily deployable manufacturing facilities are required. Innovations in flexible processes and facility designs are helping to define the facilities of the future in order to help manufacturers execute new strategies to meet the challenges within the industry.
G-CON pre-fabricated autonomous cleanroom PODs have been developed to help drug manufacturers meet these new challenges and are being designed and implemented for a broad range of process and manufacturing applications. The PODs allow for rapid deployment within an existing or new building structure in order to establish or extend manufacturing capability across the globe. The presentation will discuss the current industry needs, provide an overview of the POD technology and its advantages over traditional facilities, and share examples of POD facility designs for various drug manufacturing processes and operations.