SG US Technology Excellence Center presents a Webinar on:
Navigating major challenges associated with intrinsic subvisible particles on siliconized prefillable syringes
- Date: Thursday, August 27th
- Time: 10.00 AM ET / 7.00 AM PT / 4.00 PM CEST
- Duration: 1 hour
This webinar will focus on primary packaging, where the drug product will be in direct contact with the container closure system for a substantial period of time before reaching the patients. The physico-chemical interactions between the primary packaging components and the drug play a crucial role in the generation and release of subvisible particles. These particles could affect the safety and efficacy of the drug product and not meeting global regulatory standards. To address these concerns, we would like to present to you the background and tools used for evaluating the release of subvisible particles such as silicone oil droplets.
Key Learning Objectives:
We leverage our expertise as a leading drug primary packaging manufacturer and as an independent laboratory analyzing the subvisible particle release with a focus on the silicone oil droplets to present:
- State of the art characterization of the release and generation of subvisible particles, such as silicone from container closure systems
- Regulatory requirements described in USP, EP, JP, and ISO
- Cases studies demonstrating how to approach and test subvisible particle release on prefillable syringes:
- Optimization of the siliconization process to minimize the silicone oil droplets release
- Simulation study on the siliconization downstream processes such as filling, transport stress and extrusion
Who Should Attend:
Recommended attendees include those who are:
- Packaging Development Engineers/Scientists
Supply Chain/Clinical Operations
- CMC Scientists
- Quality Directors/Managers/Engineers
- Team Leaders/Directors of Drug (Formulation) Development Teams
- Drug Delivery/Combination Product Scientists and Engineers
- Analytical Scientists
About the speakers:
US Technical Excellence Center (TEC) Site Leader
Abizer Harianawala is the Site Leader for the US Technology Center of Excellence for Stevanato Group in Boston. He is responsible for providing integrated drug development services for parenteral products and Drug Delivery Devices. Abizer has over 20 years of experience in pharmaceutical development and commercial manufacturing operations. Before joining Stevanato Group, he was Senior Director for Product Development and Technical Operations at TARIS where he led the development of TAR-200 that was granted a fast track designation from FDA. Prior to TARIS, Abizer was a Director at ARIAD Pharmaceuticals, where he supported the development and commercialization of Breakthrough Products such as Iclusig and Alunbrig Tablets. He has also worked previously with Zalicus, Genzyme, and Bristol-Myers Squibb. He has achieved several global regulatory approvals for large and small molecules as well as combination medicinal products through standard and accelerated regulatory filings. Examples of such approvals include Iclusig, Alunbrig, Renagel, Renvela, Cerdelga, Entecavir, and Irbesartan. Abizer obtained his Ph.D. in Pharmaceutics from the University of Connecticut.
Research Scientist, Stevanato Group US Technical Excellence Center (TEC)
Gregory Fahs is leading key initiatives at Stevanato Group’s new US TEC in Boston, MA, by leveraging his background in analytical chemistry, morphology, and drug delivery. Greg was previously a scientist working on analytics and formulation development focused on the characterization of nanoparticle drug delivery systems for hydrophobic molecules. Additionally, Greg obtained a Ph.D. in chemistry from Virginia Tech with his dissertation work focused on characterizing and modeling the morphology of phase-separated polymeric materials. Greg also holds BS degrees in chemistry and applied mathematics from the University of Massachusetts, Amherst.
Research Scientist, SG Lab Analytics
Martina Marchioro is a subject matter expert in visible and subvisible particle analysis and characterization. She has been designing and developing customized methods and solutions that SG Lab Analytics offers to the Pharmaceutical companies to investigate the CCS properties and performances as a result of the interaction with the drug formulation. She earned a Master Degree in Chemical Sciences at the University of Padua (Italy) within an internship at Max- Planck Institute for Solid State Research, Stuttgart (Germany).