In many disciplines, the need for automation grows as business evolves. In cell and gene therapy, your need for automation also grows at each stage of production.
When it’s time to automate, you must consider several aspects of your manufacturing process, including quality, regulatory requirements and cost-effectiveness. GMP compliance is by far the most important: if you manage your costs but don’t meet regulations, or if you fail at quality, your product will never be released by competent authorities. In other words, there is no escape from GMP compliance.
GMP compliance is important for the entire manufacturing process, but especially at the end: your ATMP must follow guidance, and any mistake or lack of evidence can block you and waste your time and money.
In this webinar, Terumo Blood and Cell Technologies will talk about regulatory considerations and requirements for GMP compliance, the inspection approach taken by the MHRA, and some considerations companies may want to take into account within their own facilities at the fill/finish stage. The presentation will be followed by a discussion of the risks posed by the fill and finish step, and the role of automation in helping to mitigate them.
- Why GMP compliance must be central to the planning of your manufacturing process.
- How to identify specific gaps in compliance that may occur during the fill and finish process.
- How automating final formulation, fill and finish helps alleviate those pain points.
Tracy Moore EPiC Auditors, (Ex- MHRA Expert Inspector)
Tracy Moore is an accomplished quality professional with over 32-year experience of pharmaceutical manufacture, distribution and regulation gained from working within the industry and also for the GMP Inspectorate of the UK medicines regulator (MHRA) where she reached Expert Inspector level / status. During her 10 years as a GMP Inspector Tracy had responsibility for licensing and inspection of pharmaceutical manufacturers and distributors both in the UK and overseas, the development and implementation of regulations and European guidelines relating to pharmaceutical manufacture and distribution, the management of risk and noncompliance in these sectors and collaboration with other European and International regulatory authorities. Tracy has expertise across most dosage forms and in particular, sterile manufactured products produced aseptically for which she has presented on a range of topics associated with GMP Annex 1. Prior to joining the MHRA Inspectorate, Tracy spent 22 years working in both commercial and R&D environments of the pharmaceutical industry in various QA, QP and management roles covering a wide range of sterile and non-sterile product dosage forms. In addition to this she has been responsible for the audit and oversight of Contract Development and Manufacturing Organisations (CDMO), component suppliers, and API manufacturers.
Delara Motlagh, PhD MBA
General Manager, Cell Therapy Technologies, Terumo Blood and Cell Technologies
Delara is the General Manager of Cell Therapy Technologies at Terumo Blood and Cell Therapies, headquartered in Lakewood, Colorado. She is passionate about the cell & gene therapy market and the potential these innovative therapies hold to improve the lives of patients. She brings more than 18 years of experience in biotechnology and healthcare in various therapeutic areas including oncology, cardiology, orthopedics, hematology, and nephrology.
Prior to joining Terumo Blood and Cell Therapies in 2017, Delara served in diverse leadership roles at Baxter Healthcare in marketing, research & development, and operations. Her cross-functional background provides a unique perspective and deep understanding of development, cell manufacturing, and commercialization elements in the industry.
Delara received a Ph.D. in Physiology and Biophysics from the University of Illinois, fellowship in Vascular Tissue Engineering at Northwestern University, and Executive MBA from Kellogg School of Management.