This session is all about oligonucleotides. Industry experts discuss a new facility design for manufacture of mRNA therapy and personalized vaccines which includes considerations for the changing paradigm of converting 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, a discussion on the preparation and handling of the various solutions to support solid-support synthesis of oligonucleotides, and finally a glimpse into the new products of a oligonucleotide facility.
Vice Provost, Academic Affairs
University of Maryland, Baltimore County
[Large Scale Oligonucleotide Synthesis ]
Speaker: David Macdonald
This presentation will focus on the preparation and handling of the various solutions to support solid-support synthesis of oligonucleotides. The design constraints of this type of facility are quite different that those of the typical biotech manufacturing plant. The high cost of feedstocks, purity requirements, and cross contamination concerns are all contributing factors to consider when designing the synthesis process and facility. These materials are typically solvent based, which adds increased complexity with regards to fire-safe handling and emergency venting. Best practices have been developed to ensure a safe, reliable, and cleanable system.
Three points attendees will take away:
1. Constraints which typically affect synthesis facility design
2. Safety, code compliance, and property loss considerations
3. Best practices for make-up and handling of solutions in a commercial process ||
[Factories of the Future to Factories of the Here and Now]
Speaker: Indu Conley
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. ||
[Oligonucleotide Therapeutic Manufacturing]
Speaker: Cory Siddons
This presentation will provide an introduction to Alnylam, siRNA, and our clinical pipeline. I will discuss of delivery challenges with examples of advances in oligonucleotide therapies in the clinic
and growing market places pressure on manufacturers (internal and CMO). There will be an overview of key challenges associated with olgo manufacturing – some aspects of biologics and small molecule API, along with a background of new state-of-art facility, and how Alnylam is preparing to meet the challenges ahead.
Hyde Engineering and Consulting
Process Engineering Department Manager
Sr. Director, Manufacturing