The Critical Aspects to Consider When Choosing the Right CDMO for HPAPI Development, Manufacturing & Packaging

With the complexities involved in the safe handling of potent molecules and increasing regulatory requirements, it is imperative to choose the right partner for the successful development, manufacturing, packaging and ultimate commercialization of such molecules. Identifying a partner with the relevant capabilities, expertise and experience to collaborate through this journey is a critical decision point for any company looking to outsource.

The featured speakers will explore the critical factors that should be considered when choosing the right CDMO for end-to-end high-potent services.

The discussion will start with the first and most critical step of accurate potent classification and the importance of OEL assessment. The discussion will continue through the adoption of a risk management approach through SMEPAC testing as the product moves through the various stages of processing from dispensing, through granulation to final dosage.

The speakers will discuss the best practice of using fully-contained engineering solutions and applying the latest in regulatory guidance. Following the development and manufacturing processes, we will then move on to discuss the key considerations for both primary and secondary packaging. During the packaging discussion, we will consider specific aspects of packaging highly potent products including, heightened air filtration systems, ISO8 standards, room pressure differentiation and the general principles of containment controls to ensure operator safety.

If you are in the process of assessing your outsourcing options for the development, manufacturing and packaging of highly potent products or simply wish to know more about the processing of such specialist products, this webinar is designed to combine theory with practice, drawing on the experience built up over 35 years of working in this specialist space.

Speakers

David O'Connell BSc (Hons), Director of Scientific Affairs, PCI Pharma Services

After graduating from Glasgow Caledonian University in Scotland with a Bachelor of Science degree in Applied Bioscience, O’Connell spent seven years as a Supervisory Scientist working for Aptuit in Edinburgh, Scotland, before moving to Penn Pharma as Head of Formulation Development in 2009. Here he played a vital part in the design of the potent Contained Manufacturing Facility (CMF), which won the ISPE Facility of the Year award for Facility Integration (2014). In 2014 PCI acquired Penn Pharma and O’Connell took on the role of Director, Pharmaceutical Development at the PCI site in Tredegar, Wales, UK. In his current role, O’Connell aids clients with formulation development, technical transfer and scale-up of solid oral, oral liquid and semi-solid products for clinical trials and/or commercialization. David also has line management responsibility for the Validation Team (Process, Equipment and Facilities) and the Quotes proposal preparation group.

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Michael Ellingson, Operations Director, Specialty, PCI Pharma Services

Mike Ellingson joined PCI in 2010 as a Project Manager and transitioned through the Project Management side of the business through 2018. Ellingson then spearheaded the S&OP initiative with site wide responsibilities around capacity, scheduling, labor management and financial commitments. At the same time, he became the Director of Specialty Operations responsible for all aspects of the New Milford School Road site where high potent compounds, hormones and other products requiring special handling are packaged.

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