Wednesday, November 4, 2020 | 11:00 AM EDT
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:
Dr. Karen Bossert
Vice President of Operations, Lubrizol Life Science Health – CDMO Division
Vice President, Quality Assurance, Lubrizol Life Science Health – CDMO Division
Thursday, October 29, 2020 | 1:00 PM EDT
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.
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.
Director of Cell Line Development
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.
Validation Specialist III / Technical Consulting Manager, Nelson Labs
VP, Radiation Technical Services, Sterigenics
NOW AVAILABLE ON-DEMAND
The manufacturing of API is a long and complex process. The comparison between the different processes is not easy since the chemical structures vary and therefore the compounds physical properties also change.
In this webinar we will be presenting the tool we developed to be able to take advantage of 60 years of experience in developing API process. The use of this tool allows us to develop our clients' projects using a Development by Design approach and to better manage the expectations of different outputs at different lifecycle stages of the processes. This follows a structured approach which allows for a faster process development.
What can you learn from this webinar?
Join this webinar where our speakers will share their views on this new tool that is able to accelerate the development process.
Director, R&D Process Chemistry Development
Senior Scientist, R&D Process Chemistry Development
Chemistry Senior Lab Operation Manager, M.Sc., ASQ CQA and CSSGB
Nelson Labs Fairfield