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.
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.
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.
Who Should Attend?
This webinar will appeal to senior level professionals from pharmaceutical, biopharmaceutical and biotechnology companies, as well as academic institutions, with the following job titles:
- Medicinal Chemistry
- Analytical Chemistry
- API/HPAPI Development/Manufacturing/Packaging
- Chemical/Manufacturing Engineering
- EHS Specialists
- Processes Safety Scientists
- Analytical R&D
- Chief Scientific Officers
- Research Scientists
- Outsourcing specialists
What You Will Learn
Attendees will learn about:
- The key considerations in the development, manufacturing and packaging of highly potent products
- The complexities involved with the processing of highly potent molecules, including OEL assessment, safe processing and cleaning procedures
- Regulatory guidelines and best practice for the safe handling of highly potent molecules
- The key considerations when identifying and evaluating a potential CDMO partner for HPAPI development, manufacturing and packaging
PCI Pharma Services
PCI Pharma Services is an integrated full-service provider and a trusted partner to our pharmaceutical and biopharmaceutical customers. We provide unparalleled expertise in the delivery of manufacturing, clinical and commercial supply chain solutions in the shared goal of improving lives as the bridge between life-saving therapies and patients. We are a leader in providing client-focused solutions, engaging a flexible team and consultative approach with our people making the difference. We are dedicated to providing the best service and experience and committed to delivering life-changing therapies to those who need it most, anywhere in the world.