Stem cells and other regenerative medicine products offer considerable benefits to patients as well as potential financial rewards for companies. At the same time, cell-based therapies present challenges to regulators because, in many cases, they involve withdrawing cells from a patient’s bone marrow, blood or adipose tissue, growing cells in vitro with minimal to extensive manipulation, and then administering in some form the expanded (and possibly modified) cells population back into the patient.
Join this webinar to learn more about this unique approach and how you can benefit from it in different situations. Our Chief Scientific Officer will share the theory and background behind the solution and demonstrate how Unscrambler® X Batch Modeling from CAMO can improve the way we manage time-dependent processes and as an effect, get better quality control, detect events early and overall help improve quality of products and processes.
The webinar will explore: the EU risk assessment guideline for excipients, suppliers' and pharmaceutical companies' roles and responsibilities in the risk assessment process, and the Emprove® Program: New regulatory documentation that supports a risk-based approach.
This webinar will offer insight into current and upcoming industry and regulatory requirements for filters, such as more detailed compatibility and extractables data. In addition, a review of single-use filter quality and regulatory documentation based on these requirements will be covered, which will make risk assessments, based on ICH Q9 guidance, more efficient for the sterile drug product manufacturer.
During this webinar you will learn about the evolution of excipient GMP from guides to standards. A review of the current excipient GMP standards will be covered; specifically, it will include an explanation of what the EXCiPACT™ certification scheme is and how it includes a standard for excipients. Additionally, a review of the currently published NSF/IPEC/ANSI 363 GMP excipient standard will be covered. Lastly, we’ll discuss and review our approach for providing Emprove® documentation to support our customers.