Navigating the sterile fill finish CDMO landscape for development and manufacturing success

CDMO capability assessment, facility design, EU GMP Annex 1 compliance and formulation strategies for sterile liquid and powder drug products.
June 25th 2025
15:00pm (BST) / 10:00am (ET)
OVERVIEW

Navigating the CDMO landscape for fill/finish services can be complex and time-consuming, from evaluating capability to compliance, quality, and expertise. How selecting the right CDMO partner can help position your liquid and powder sterile products for success at each stage of the development process. Join industry experts as they share key strategies for accelerated formulation development and examine the impact of revised EU GMP Annex-1 regulations and PUPSIT on CDMO capability and selection.

Learn what to look for when assessing a sterile fill/finish CDMO for your next project, including how facility design and equipment impact sterility assurance and quality. Our speakers will discuss the specialist expertise required to support sterile powder and liquid development, providing actionable insights on technology transfer, formulation optimization, and regulatory considerations that can streamline your path to clinical trials.

 

This webinar is designed specifically for biotechs in early-stage development (Phase 1-Phase 2 clinical trials) currently evaluating CDMOs to support their sterile drug product development. Attendees will gain valuable perspectives on risk mitigation strategies, quality control parameters, and compatibility considerations that are essential when selecting a partner for these critical services. Whether you’re working with biologics, small molecules, or complex formulations, this session will equip you with the knowledge to make informed decisions about your sterile manufacturing partnerships.

Addressed Challenges

01  Evaluating sterile fill/finish CDMOs across capability, compliance, quality standards, and regulatory expertise for each specific development stage. 
02Understanding the impact of revised EU GMP Annex 1 regulations and PUPSIT requirements on CDMO selection and facility design decisions. 
03Overcoming formulation challenges specific to liquid and powder sterile drug products during development and clinical manufacturing activities. 

WHAT YOU WILL LEARN

01Learn what to prioritise when assessing a sterile fill/finish CDMO, including facility design, equipment choices, and sterility assurance capabilities. 
02Understand how facility design and equipment decisions directly impact sterility assurance, quality outcomes, and regulatory compliance readiness. 
03Gain insight into Upperton Pharma Solutions' sterile fill/finish capabilities for supporting liquid and powder drug product development programmes. 
Reserve Your Seat
SPEAKERS
Upperton webinar
Ian Lafferty
Chief Technical Officer
Ian has 25 years’ technical, operational experience gained in early phase pharmaceutical development, encompassing the formulation design and development, process optimisation and manufacture of a wide range of dosage forms including oral solids, nasal drug delivery, inhaled powders, suspensions and injectables with a focus on challenging molecules, enabling technologies and high potent handling. Ian also has significant experience in facility design and management. Ian has previously held senior management and executive roles at a number of emerging and growing CDMOs, providing strategic and operational leadership to ensure excellence in all aspects of providing pharmaceutical services.
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Josh Haye
Development Manager
Josh has over 10 years' experience in the pharmaceutical industry, having previously held Manufacturing Scientist and Senior Formulation Scientist positions, prior to joining Upperton in 2024 as a Development Manager within the Research & Development team. Josh's experience covers both non-sterile and sterile pharmaceutical formulation and product development.
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