Wednesday, February 24, 2021 | 1:00 PM EST
Are you wondering how to set up a stability test plan for your vial product? Are you confused at all the options for Container Closure Integrity Testing and wondering how to decide which one to choose for your product? Then join us for a webinar on Stability and CCI testing. We will outline the basics for setting up a stability test plan for rigid containers including aging conditions and testing frequency. We will look at how probabilistic methods differ from deterministic methods and will discuss each of the common CCI test options outlined in USP 1207. We will conclude with CCI method validation basics.
Agenda:
Presenter:
Jennifer Gygi, B.S., SM(NRCM)
Expert Technical Consultant, Nelson Labs
NOW AVAILABLE ON DEMAND
Univercells Technologies has been working to leverage deep expertise in bioprocessing and equipment development to revolutionize virus manufacturing for gene therapy and vaccine production. By combining the principles of intensification and chaining, the company has introduced the NevoLine™ Upstream platform, a fully automated and integrated biomanufacturing unit designed to enable commercial scale capacity in a compact module.
Directly from its development site in Belgium, Univercells Technologies is inviting you to join the virtual product launch of this breakthrough technology. The event will highlight the features of the NevoLine Upstream platform, including an explanation of the main benefits and key performance data. Attendees will see how users of the NevoLine Upstream platform can increase viral productivity while benefiting from a flexible process approach in a reduced footprint.
The event will offer:
NOW AVAILABLE ON-DEMAND
Learning Objectives
Who is it for:
Speaker:
Ben Wylie
Senior Product Manager, ChargePoint Technology
NOW AVAILABLE ON-DEMAND
Are you developing a biologic, biosimilar, or other complex drug product requiring lyophilization? Register for this webinar from Lubrizol Life Science to explore key considerations in designing and executing aseptic process simulations for lyophilized products, including a deep dive into study design, operational considerations, and regulatory guidance. Learn how robust validation can lead to commercial manufacturing success.
Key Learning Objectives:
Speakers:
Dr. Karen Bossert
Vice President of Operations, Lubrizol Life Science Health – CDMO Division
Judy Cohen
Vice President, Quality Assurance, Lubrizol Life Science Health – CDMO Division
NOW AVAILABLE ON-DEMAND
Piramal Pharma Solutions will present data from a simple OFAT experiment varying TCEP:mAb ratio to highlight the variability in distribution of species in some key assays supporting critical quality attributes of an Antibody Drug Conjugate. Piramal will discuss how this experiment can support product and process knowledge during product development (both early and late phase). We will aim to show how a small number of experiments can generate a large amount of data that is valuable to clients at key points during product development.
Speaker:
Allan Davidson
Head of Department, Analytical Development, Piramal Pharma Solutions
Expediting development timeline is directly related to obtaining IND clearance and starting phase 1 study faster. This webinar describes how you can get to IND faster through our accelerated & high performance proprietary cell line, S-CHOice; Samsung Biologics presents 3-month cell line development timeline and high-quality cell line. In addition, we will present the combined benefit with S-CHOice and 2-step purification platform, which can further expedite the timeline as well as reduction in manufacturing costs. We hope to share how our Faster & Better approach can be applicable to your molecule's successful development path to IND.
Speakers:
John Gill
Director of Cell Line Development
Beomkyu Kim
Lead Scientist of Downstream Process Development
Plus, a discussion on the new container closure integrity testing: Mass Extraction
NOW AVAILABLE ON-DEMAND
This webinar is designed to build your foundational knowledge of pharma packaging. The type and method of packaging is an important consideration for radiation processing using gamma and electron beam. This webinar discusses how product packaging and presentation (density, weight and product orientation) can affect routine processing. Examples will be presented about how certain considerations are taken into account when developing the product packaging to ensure an effective radiation sterilization process. The webinar will also cover mass extraction, a relatively new container closure integrity test which is included on the USP 1207 list of approved deterministic CCIT test methods. You will learn the basic methodology behind a mass extraction test, the advantages of mass extraction testing over other CCI methods, and how the test is performed.
Speakers:
Jennifer Gygi
Validation Specialist III / Technical Consulting Manager, Nelson Labs
John Schlecht
VP, Radiation Technical Services, Sterigenics