Advanced Pharmaceutical Manufacturing
ฝัง
- เผยแพร่เมื่อ 6 มิ.ย. 2024
- There are a number of challenges that the industry faces in order to transition towards more competitive, systematic and efficient manufacturing. Regulatory authorities have recognized the deficiencies of pharmaceutical product manufacturing and aim to enhance process understanding through Quality by Design (QbD) and Process Analytical Technology (PAT) tools. As a result of this current effort to change the mindset in order to mimic the rest of the chemical industry, an additional transition is becoming more and more appealing: transition from batch to continuous production mode. However, continuous manufacturing requires detailed process understanding in terms of the evolution of all critical material properties as a function of its operating parameters and environmental conditions. Once process knowledge is translated into models, computer aided dynamic simulation tools will allow the design, analysis and optimization of continuous integrated processes.
In this talk I will discuss the work that has been done in my lab towards the development of an integrated platform that will enable the efficient flowsheet simulation and analysis, the assessment of design alternatives, the feasibility analysis of the production line, and the control and optimization of process design and operations.
The developed flowsheet model includes modules for all the necessary unit operations, namely powder feeding, mixing, roller compaction, tablet press and milling integrated to represent a tablet manufacturing line. Models used to represent each unit operation vary from empirical, first-principle or hybrid. Population balance models are developed in order to track the composition and particle size changes throughout complex powder processes dynamically. The developed flowsheet simulation is used to predict the propagation of upstream disturbances to final product quality, the assessment of recycle stream benefits, the identification of process integration bottlenecks and evaluation of different control strategies in order to retain the process within its design space. In addition, global dynamic sensitivity analysis is performed to identify critical process parameters not only within each unit operation, but also between different processes. Finally, simulation based optimization techniques enable the identification of the optimal operating conditions, as well as the optimal design sequence which leads to pharmaceutical tablets with desired characteristics. This work aims to merge knowledge, experience, experimental results and modeling tools for developing a dynamic simulation platform that will enable the safe implementation of the transition towards continuous pharmaceutical manufacturing.
Biography:
Marianthi Ierapetritou is a Professor and Chair in the Department of Chemical and Biochemical Engineering at Rutgers University in Piscataway, New Jersey. Dr. Ierapetritou’s research focuses on the following areas: 1) process operations; (2) design and synthesis of flexible production systems focusing on pharmaceutical manufacturing; 3) modeling of reactive flow processes; and 4) metabolic engineering with focus on biopharmaceutical production. Her research is supported by several federal (NIH, NSF, ONR, NASA) and industrial (BMS, J&J, ExxonMobil, Honeywell, Cardinal Health) grants.
Among her accomplishments are the Outstanding Faculty Award, the Rutgers Board of Trustees Research Fellowship for Scholarly Excellence, and the prestigious NSF CAREER award. She has more than 180 publications, and has been an invited speaker to numerous national and international conferences.
Dr. Ierapetritou obtained her BS from The National Technical University in Athens, Greece, her PhD from Imperial College (London, UK) in 1995 and subsequently completed her post-doctoral research at Princeton University (Princeton, NJ) before joining Rutgers University in 1998. - วิทยาศาสตร์และเทคโนโลยี
I like this post, very informative and nice. Thank you.
Thanks very much for this relevant information.
that is nice post,.thanks for posting
I love pharmaceutical powders! Thanks!
FANTASTIC WEBINAR!
I am new to pharmaceutical industry and I found this is very informational!
+Wajahat Wajahat I enjoyed the presentation as well. Marianthi gave a great plenary style talk.
Thank you for your sharing!
good.I try my best accordingly!
Its very nice
it is informative
informative
Are the tiny beads in a capsule the same strength ?
I don't think she checks the comments here. I'd recommend that you reach out to her with any specific questions about the presentation.
Content starts at 4:04
This was my professor!
This is my boss small world huh 😅 the cartel pays really good I love my job
Can I knw how to make pregabalin drugs in the pharmaceutical sector
En Español por favor, para entender bendiciones
i have bad head ake but canot aford the medicine can you help me please
+johnny rigdon, ideas like those presented in the video may improve efficiency of manufacturing. I hope you feel better soon.
Very nice information and good advice
thick accent
Too much "Bragging" - get to the point and get a better microphone !!!
Makes it sound very un-professional. Marianti sounds like her accent is from India - meaning using ah ah ah ah - sounds like a lot of words many don't even understand - get to the point for us simple folks !!!
Cheryl Kreske We hold these webinars via WebEx so the sound quality isn't optimal. Thanks for the suggestion - I'll look into methods to improve the sound quality. This webinar was delivered to a group interested in process control and optimization methods. I agree that it isn't for everyone but it is very valuable for this community. Marianthi is from Greece and a very well respected researcher - we were very lucky to have an opportunity to hear from her. Below is a link to some of her work: scholar.google.com/citations?user=kmP8BqMAAAAJ&hl=en
Cheryl Kreske apologies but it was the first time giving a webinar and it is definitely not the same as having a live audience. I should say that we practiced the microphone and it appeared to give acceptable quality but not the optimal. I would love to explain anything it was not clear and give you more background on the work we are doing in this area.
Marianthi is the best professor I've ever seen. Her accent is clear and recognizable. Greek people have very unique English accent but after having conversions with them for a longer time you will find out that their English is pretty good. And I like their accent. if you check nowadays process system.engineering field and most of the big scholars are from Greek. Like Dr. Floudas, Dr. Pistikopoulos, they have very solid math background. You should not focus on the minor language difference but instead look at the greater research picture. She has explained the research work in a very straightforward way with putting out tremendous math equations and optimization theorems. It's great to watch the valuable overall reasearch introduction online for free.
It is a bit sad you don't have a Linkedin account Professor Marianthi :(
@@engineerSalih turns out she's on linked in now