Oral drug delivery technologies form an important part of the pharmaceutical industry, and represent the largest share of the overall market.
Rising healthcare costs will continue to drive the demand for affordable biosimilar therapeutics. As the regulatory frameworks globally are complex, it is increasingly important for contract organizations to provide the expertise regarding the technology and processes essential for optimized biosimilar development.
The presentation will discuss the current scientific challenges developing biosimilars with special emphasis in the importance of stable, high performance cell lines, clone selection and process development and how to leveraging expertise in large molecule analytical services to generate highly similar biosimilar molecules.
The webinar will be split into two sections, the first focusing on cell line engineering through utilization of the GPEx® technology platform, and an example applying iterative analytics to yield a clone and a manufacturing process yielding a highly similar biosimilar protein.
The second part of the webinar will discuss the application of physicochemical, structural and functional (bioassay & ELISA) strategies, among others, to the full biosimilarity characterization lot comparability testing as well as subsequent lot release and stability testing, of biosimilar therapeutics.
For anyone involved with the development, manufacture and/or release of biosimilar therapeutics, this webinar will provide vital insights as to how we may be able to work with you in your efforts to develop and produce biosimilar therapeutics, making the challenges more predictable, robust and efficient.
As your strategic partner for Biologic and Biosimiliar development, our unique technologies and integrated services will help you to get more and better products to clinic, faster. Catalent has the expertise and flexibility to create tailored solutions, with several cell lines clinically and commercially validated,and in depth analytical and regulatory services experience, that optimize and accelerate the drug development process.
Michael Sadick, Ph.D.,
Senior Manager, Large Molecule Analytical
Dr. Sadick is a Senior Manager at Catalent Pharma Solutions organization, in Kansas City, MO, in the Large Molecule Analytical Chemistry (LMAC) department, overseeing and leading the support of analytical techniques and strategies that include Bioassay, ELISA, Binding Kinetics and Molecular Biology. He has worked at Catalent Pharma Solutions (formerly part of Aptuit, Inc,) since 2007.
Rob Gustines,
Director Biologics
Mr. Gustines is responsible for Catalent’s Biologics Business Development activities in the Eastern U.S. and has been involved with biologics, specializing in mammalian expression technologies from the lab bench through clinical development and cGMP production, for over 20 years. In Business Development Mr. Gustines works with Catalent clients to access the GPEx ® cell line technology platform and for the manufacture of their biologic drugs.
- The fundamentals of the GPEX technology and how it works
- Step by step of cell line engineering process, applied analytical, process development and manufacturing processes essential for successful biosimilar development programs
- Learn an orthogonal approach, utilizing physicochemical, structural and functional strategies
- Each particular biosimilar molecule will require customized combination of analytical techniques and how this applies for CMC testing for biosimilar therapeutics
- Quality/Regulatory/Compliance
- Research and Development
- Marketing/Product Management
- Procurement
- Outsourcing/3rd Party
- Corporate Development
- Commercial Operations
- Chief Scientific Officers
- Chief Executive Officers
