Joshua Kulakofsky
Seminars
- Which process monitoring technologies will actually deliver measurable ROI in the next 3–5 years, and how do you prioritise investment to avoid over‑promising and under‑delivering?
- How can organizations confidently balance innovation with GMP risk, product sensitivity, cost, and operational complexity to ensure new technologies enable rather than disrupt manufacturing performance?
- In what ways can evolving regulatory guidance be leveraged to accelerate adoption and strengthen control strategies, rather than acting as a barrier?
- What approaches actually work when retrofitting new monitoring tools into legacy systems, and when does it make more sense to invest in greenfield solutions?
As process monitoring evolves from a supporting activity into a dedicated, value‑driving function, many organizations face the same challenge: how to integrate new technologies without disrupting validated processes or manufacturing continuity. This workshop brings together industry peers to share practical experiences of introducing and scaling new tools in real GMP environments.
Through real‑world case studies, participants will explore how autosamplers, advanced sensors, digital platforms, and AI are being applied in practice; what worked, what didn’t, and why. Highly collaborative and discussion‑led, this workshop is designed to help attendees understand not just what technologies are available, but how to implement them successfully, turning process monitoring into a sustainable capability that delivers long‑term manufacturing value.
This workshop will gather experts to discuss:
- Showcasing new uses of Raman spectroscopy beyond its traditional biologics applications to unlock new process insights across modalities
- Discussing the use of online LC in biologics downstream processing, highlighting both its potential and current limitations in wider industry adoption
- Exploring how these innovations enable deeper process understanding, improve control strategies, and ensure successful transfer to manufacturing
- Actualizing improved manufacturing efficiencies through improved yields, control of cycle times, and reductions in testing all while increasing the level of product monitoring
- Scaling proven technologies across products lines to maximize ROI, improving continuous process improvement efforts, drastically improving capabilities for future process development efforts while enabling consistent, streamlined process monitoring at scale
