Event Overview
Exploring integrated CDMO approaches to accelerate sterile drug product development and clinical entry.
Key Topics at a Glance
- Sterile Fill/Finish
- Formulation Development
- Annex 1
- Aseptic Processing
- Spray Drying Biologics
- Sterile Manufacturing
- Clinical Submissions
Event Overview
This event is focused on the critical challenges of advancing complex molecules to early clinical sterile development, particularly within the constraints of Annex 1 compliance.
The session combines introductions, networking, and a facilitated seminar to explore key issues such as securing small-scale aseptic capacity, managing accelerated clinical submission timelines, and overcoming formulation hurdles for spray-dried biologics.
Upperton’s 16-week sterile manufacturing roadmap will highlight how you can move from formulation to clinical submission sooner and with greater confidence. The discussion will extend to practical strategies for navigating CDMO selection and applying enabling technologies like spray drying for high-concentration biologics, providing a realistic path to faster clinical progress.
Key Reasons to Attend
Accelerate timelines to clinical submission
Learn CDMO approaches to reducing sterile development and manufacturing bottlenecks to support faster clinical readiness.
Navigate EU GMP Annex 1 with confidence
Understand the key regulatory and operational considerations required to maintain compliance under accelerated timelines.
Make Better Early Formulation and Process Decisions
Make Better Early Formulation and Process Decisions Understand how to leverage enabling technologies like spray drying to solve complex solubility and bioavailability challenges upfront.
De-Risk Early Clinical Development
Make smarter formulation, process, and manufacturing decisions earlier to reduce downstream risk and improve program efficiency.
Gain Real-World Insights & Build Strategic Connections
Hear practical perspectives from experienced CMC and manufacturing leaders while networking with senior biopharma decision-makers in an exclusive setting.
Speakers
Agenda
10 am – 10:30 am
Welcome, introductions and refreshments
10.30 am – 11:30 am
Sterile Manufacturing
A technical discussion about Annex 1 in practice, navigating the fill/finish CDMO landscape and strategies to avoid critical path delays to reach clinical submission in 16 weeks.
11.30 am – Q&A
12 pm – 1 pm – Lunch and Networking
1 pm – 1:30 pm –
Formulation and delivery of complex molecules through spray-drying
Practical insights for overcoming complex sterile formulation challenges with enabling technologies, and the applications of spray drying for high-concentration biologics.
1:30 pm – 1:45 pm – Q&A
1:45 pm – 2 pm – Closing remarks
2 pm – Event close