This year, FUJIFILM Diosynth Biotechnologies (FDB) continued hosting our informative series of Lunch and Learns. Held at our Cambridge Collaboration Center (C3) in Cambridge, MA, these events are dedicated to sharing industry-specific scientific topics and best practices while fostering collaboration with colleagues.

Subject matter experts from across our FDB global network spoke at these events, sharing valuable insights on topics including the development of gene therapies for rare diseases, process characterization, and strategies for a diverse mAb pipeline. In case you missed any of our 2023 sessions, here is a recap of the highlights and links to the recordings.

February 2023: Early-Stage Considerations for the Development of Gene Therapies for Rare Diseases

Kicking off the year, FDB’s Head of Process Development, Samantha Hullah, shared the key considerations for early-stage process development and the pathway to cGMP manufacturing. Attendees gained insights on how to ensure the best start when working with their CDMO, the critical steps in process and analytical development, and scaling up for subsequent phases and commercial production.

April 2023: Paveway™ PLUS: Microbial Expression Coupled to Modern Small-Scale Purification and Analytical Techniques for Informed Rapid Lead Strain Selection

Our audience joined FDB’s Chris Lennon, Director of Microbial Upstream Process Development, to discuss Paveway™ PLUS – our proven technology platform for efficient microbial expression of proteins, using novel recombinant E. coli strains. Chris outlined how the capability of the platform has been enhanced through using a scale down/high throughput approach to protein purification using robotics to enable strain selection based on parallel evaluation of product titer and quality.

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May 2023: Process Characterization: FDB’s Role in the Path to Commercialization

FDB’s Kathy Patton, Director of Process Characterization and James Wood, Director of Process Characterization Process Development, teamed up to explain how we can deliver a first-in-class Process Characterization (PC) program as you approach your late phase clinical stage, as well as how we integrate PC program design and execution to support your product registration and commercialization strategy.

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July 2023: Toxicology – The “Safety Countercurrent Exchange”: Leveraging Biorisk Management and Quality Synergies in CDMO Operations

July saw us focus on biosafety, toxicology, and quality program elements that transcend all laboratory and manufacturing operations, as well as using appreciative inquiry as a change management tool in safety infrastructures. AJ Troiano, FDB’s Director of Biosafety and Toxicology, shared his expertise on how biocontainment and cross-contamination – directly opposed ideologies – provide crossover elements that can be leveraged to build a better, holistic, more efficient safety program.

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August 2023: Process Development and Manufacturing Strategies that are Versatile, Rapid and Robust for a Diverse mAb Pipeline

Leon Pybus, FDB’s Associate Director for MCC Process Development, gave an insightful talk on the key mAb platform components that assist from lead molecule identification to cGMP production. Leon also covered development considerations for successful cGMP manufacturing, and the impact of engineered mAb variants such as Fc-fusion and mAb bispecific molecules on development and manufacturing strategies.

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November 2023: Starting with Fill Finish in Mind: An Overview of FDB Drug Product and Finished Goods Services

To close out the year, FDB’s Cristina Brinkmann, Business Steering Group Lead for Drug Product and Finished Goods, and Nadiyra Walker, Head of Drug Product and Finished Goods Manufacturing, presented on how we integrate Drug Substance, Drug Product and Finished Goods into all stages of the biopharmaceutical manufacturing lifecycle – offering an end-to-end experience.

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Thank you to everyone who took part in and attended our 2023 Lunch and Learns. Stay tuned for updates on next year’s events – we hope to see you in 2024! In the meantime, contact us here if you would like to discuss your project or learn more about our services.