Highly Potent Oral Solids:
Challenges and Considerations
About this webinar
The number and potency of highly potent drug substances are increasing. Formulators working with highly potent active pharmaceutical ingredients (APIs) are challenged to ensure the safety of personnel during development and manufacturing and healthcare workers and patients when using the final drug products. That means addressing potential issues with the homogeneity of the formulation, drug content analysis, and proper handling.
In the manufacture of highly potent compounds, special consideration needs to be given to the technical and organizational controls that will ensure operator safety and minimize cross-contamination risks. Understanding product classification and the heightened complexity of transfer and manufacturing is critical to the success of bringing these highly potent medicines to patients in need.
Register for this webinar to hear Pfizer CentreOne’s oral solids (OSD) experts discuss key consideration highly potent oral solids (HPOSD), focusing on three key challenges faced during development and manufacture. Discover more about the challenges and considerations when developing and manufacturing your HPOSD and sign up for this webcast.
Who should attend
- Corporate Development & Technology
- Product Development and Operations
- Executive Director
- Chief Executive/Scientific Officer
- Business Development
- Regulatory Affairs and Product Development
- Technical Operations
- Pharmaceutical Development
- Product Development/Manufacturing Controls
- Manufacturing Services
- Formulation Development
What you will learn
- Understand the importance of containment strategies during manufacturing
- Learn about key regulations relevant to highly potent oral solids
- Explore the formulation challenges relating to highly potent oral solids
Featured Speakers
Valeria Giannelli
Valeria Giannelli is a High Active Team Manager at the Pfizer Ascoli Site, responsible for leading the high active production team. She joined Pfizer in 1999 as an analyst in the Microbiology lab and went on to lead the department. Valeria then moved to a leadership position in the Quality management team of all site manufacturing departments before moving to her current position. She holds a master’s degree in Biology specializing in environment and microbiology from l’Aquila University.
Francesco Pastore
Francesco Pastore is Plant Logistics Manager at the Pfizer Ascoli site and is responsible for the receipt and storage of all materials and the distribution of finished products, including the total management of controlled drugs. For over 20 years he held positions as manager in the production and packaging areas of the site, specializing in the industrialization of high containment processes and collaborating with engineering in the construction of completely segregated departments. A Pharmacy graduate, he joined Pfizer in 1992, starting in the Quality and Technical Service departments. He has participated as a speaker at conferences and training courses about the manufacture of highly potent drugs.
Angelo Pisetta
Angelo Pisetta is a Process and Technical Skills Advisor at the Pfizer Ascoli site for all technical aspects regarding primary and secondary technology transfers. Angelo was formerly a Technology Transfer project leader for several projects and his role focused on new process development, improving process robustness and process optimization. In previous roles, he also led Solid and Packing departments at the Ascoli Piceno Plant.
Angelo joined the Ascoli site in 1992 as a Validation Assistant and moved to become a Quality Manager. He holds a degree in Pharmaceutical Chemistry and worked as researcher in Organic Chemistry at Camerino University.
Dimitris Tsimachidis
Dimitris Tsimachidis is Senior Sales Manager for Pfizer CentreOne’s Contract Manufacturing Business in Europe. He is responsible for the development of new business via prospecting, qualifying, and selling contract development and manufacturing services for small molecule APIs, large molecule biologics, oral solids and sterile injectables.
Prior to joining Pfizer in 2018, Dimitris held various positions in R&D, Sourcing, Product Development, Business Development and Licensing across the Pharmaceutical industry over the last 12 years. Dimitris has a Chemistry degree from Aristotle University of Thessaloniki, an MSc in Chemical Analysis from National University of Athens and an MBA from Vlerick Business School.
Partner for this event
Pfizer CentreOne®
Pfizer CentreOne is a global CDMO embedded within Pfizer and a leading supplier of specialty APIs. Our global manufacturing network includes more than 35 sites across six continents. Backed by Pfizer resources, we deliver technical expertise, global regulatory support, and long-term supply. For more than 40 years, we’ve been guiding complex compounds securely and efficiently from development through commercial manufacture.
Working together with our customers, we combine our technical and commercial knowledge with open dialogue to solve challenges. Intelligent collaboration with Pfizer CentreOne. For more information, visit www.pfizercentreone.com.