14th October 2026 | Hilton Woburn Boston
The Next-Generation Process Development & Manufacturing Summit is a focused, one-day meeting bringing together industry experts across biologics process development, manufacturing, CMC strategy, and drug product development. The agenda covers the complete development pathway, from early process optimisation and scale-up readiness through to purification, regulatory alignment, formulation, and commercial manufacturing.
Through a combination of keynote presentations, spotlight sessions, pre-arranged one-to-one meetings, and in-depth roundtable discussions, the summit explores key challenges including accelerating process development timelines, maintaining product quality during scale-up, overcoming manufacturing and purification bottlenecks, and building resilient supply chains. Sessions will also examine evolving CMC and regulatory expectations, next-generation formulation technologies, lifecycle management, and patient-centric biologics design.
Designed for senior scientists and decision-makers, the summit emphasises interactive, discussion-led sessions that enable peer-to-peer exchange, collaborative problem-solving, and strategic networking across the biologics process development and manufacturing ecosystem.
Audience Snapshot
VP/Head of Process Development, Director of Process Development, Process Development Lead, Principal/Senior Scientist
VP/Head of Manufacturing, VP/Head of Technical Operations, Manufacturing Director, MSAT Director/Lead, Operations Director
Head of Downstream Processing, Downstream Development Director, Purification Director, Downstream Lead, Principal/Senior Scientist
VP/Head of CMC, CMC Director, Regulatory CMC Director, CMC Programme Lead, CMC Project Manager
Head of Drug Product, Head of Formulation, Drug Product Director, Formulation Director, Principal/Senior Scientist
Head of Technology Transfer, Head of Supply Chain, External Manufacturing Director, Process Scale-Up Director, Tech Transfer Lead, Supply Chain Director
Summit Agenda
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30 mins
Head to the registration desk to pick up your name badge and your personalized agenda from one of our friendly team. Feel free to ask us any questions you might have about the day ahead!
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30 mins
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50 minsAccelerating biologics process development. Product quality. Managing technology transfer and scale-up challenges.
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50 minsNext-generation filtration technologies. Technology implementation & scale-up. Manufacturing efficiency
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50 minsCMC strategies. Navigating a complex regulatory environment. Aligning development activities with regulatory expectations.
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50 minsFormulation & drug product strategies. Patient and commercial considerations. Enhancing product stability and lifecycle management.
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30 mins
Dedicated time reserved for your pre-booked 1:1 meetings with our event partners and / or to networking with your senior industry peers.
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30 mins
Dedicated time reserved for your pre-booked 1:1 meetings with our event partners and / or to networking with your senior industry peers.
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15 mins
Grab a refreshing beverage and tasty snack to power you through the next round of expertly curated roundtables, led by our industry partners.
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50 minsProcess optimisation. Product quality. Scale-up readiness.
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50 minsManufacturing efficiency. Purification performance. Supply chain resilience.
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50 minsCMC planning. Regulatory alignment. Submission readiness.
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50 minsNew formulation technologies and strategies. Patient experience. Translating to commercial success.
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60 mins
Retreat to the on-site restaurant, where you will be treated to a delicious lunch menu featuring a selection of dishes freshly prepared for you.
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30 mins
Upstream process development Downstream manufacturing enhancements Product quality and consistency Scale-up strategies
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30 mins
Dedicated time reserved for your pre-booked 1:1 meetings with our event partners and / or to networking with your senior industry peers.
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30 mins
Dedicated time reserved for your pre-booked 1:1 meetings with our event partners and / or to networking with your senior industry peers.
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30 mins
Next-generation formulations. Digital health integration. Personalised therapies.
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15 mins
Grab a quick beverage and delicious snack to power you through the exciting afternoon sessions. Don't forget to network and make a new connection.
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50 minsProcess optimisation. Scale-up strategies. Product quality.
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50 minsOperational excellence. Supply chain resilience. Manufacturing flexibility.
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50 minsCMC strategy. Regulatory alignment. Global compliance.
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50 minsFormulation innovation. Drug delivery advances. Patient-centric design.
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60 mins
Relax at the end of a highly productive day, grab a cool, refreshing beverage and a delicious snack, and catch up with colleagues and newly formed connections to reflect on the day.
