Factories of the Future to Factories of the Here and Now: New Generation Biologics
3:00 PM – 4:00 PM |
In response to the advent of innovative and advanced therapy medicinal orphan drug products, pioneering facilities must be designed and constructed to meet the manufacturing needs of these game changing orphan drug therapies. Technologies are evolving with the therapies, requiring flexible and creative thinking design teams to create leading edge facilities to manufacture these new medicines. We will discuss a new facility design for manufacture of mRNA therapy and personalized vaccines. The presentation considers the changing paradigm from large volume facilities with mature technology to small, flexible multiple processing units, innovative new technologies, clinical and commercial batches in a single facility, flexibility in scale adjustment and miniature drug product batches. We address additional challenges such as the overlap between biologics and small molecule chemistry with some of these ground breaking medicines.
The changing paradigm from large volume biologics to smaller innovative orphan drugs presents new challenges and opportunities for leading edge facility designs, implementing new and evolving technologies and addresses all the cGMP and regulatory challenges to achieve a fit for flexible purpose, – inspection ready facility. As technologies continue to evolve we have to be creative with our facility design to respond to these changes while addressing the speed to market requirements for these life saving therapies. We have to respond to the problem issue that no existing framework exists in many cases for manufacturing or logistics compared to the frameworks for small molecule therapeutics or standard biologics that have been in place for many years.
The presentation will present a real life project and share the journey undertaken to design and build a facility for ground breaking therapeutics with a process with limited industry benchmark information.
Speaker: Indu Conley | Process Engineering Dept. Manager, DPS Group
Indu Conley is the Process Engineering Department Manager with the DPS Boston, MA USA office. She has more than 18 years of experience in the biopharmaceutical industry with significant experience in large-scale mammalian cell culture processes. Her design experience includes all stages of biologic process unit operations, including, harvest, TFF systems, chromatography, and filtration systems. Indu began her career on the owner side of the business and gained significant experience as a lead engineer for a biologics manufacturing facility; this experience brings valuable operational and plant experience to her design approach. Indu is an active member of ASME BPE (American Society of Mechanical Engineers Bioprocess Equipment) in which she serves on the standards committee for design and is also a member of AIChe and ISPE Boston.
Speaker: Ryan Williams| Project Architect, DPS Group
Ryan Williams, AIA, Project Architect at DPS Group, offers over 16 years of architectural experience, and has worked with a variety of clients, building typologies and project scales. He has completed significant new building and retrofit projects for leading companies in the biotech/pharmaceutical industry to include the recent completion of a new 200,000 SF, mRNA clinical manufacturing facility for Moderna Therapeutics in Norwood, MA. As project architect, he has the expertise to translate complex clients’ project goals to this team to effectively lead the project from visioning through on-site construction administration; and consistently delivers high-quality of work to our valued clients. Ryan is a Registered Architect in Massachusetts and Georgia and holds a Bachelor of Architecture from Boston Architectural College.