Process validation encompasses a lifecycle approach which includes three stages: Process Design or Development (Stage 1), Process Performance Qualification (Stage 2) and Continued/On-going Process Verification (CPV, Stage 3). The 3 stages are typically a long manufacturing journey where extensive data is accumulated, trended, and analyzed. Thus, CPV highly recommends process automation, PAT (Process Analytical Technologies) and a deep knowledge of the manufacturing process and drug product. Continued process verification enables concepts like real time release (RTR), use of continuous manufacturing or Golden Batch, but it is still not adopted in Pharma.
The established conditions (EC), critical quality attributes (CQA), and critical process parameters (CPP) are not enough to describe a real, complete picture and history of the process. Manual operations, environmental variables, seasonality components and many other factors are affecting the process inducing a permanent variability. Statistics and Multivariable Analysis can be complemented with artificial intelligence (AI) to boost the stage 3 towards a reality and a continuous state of the art in biopharma manufacturing.
During the webinar, panelists will explain how Artificial Intelligence allows predicting, classifying, recognizing and recommending improvements to the process which leads to enhanced product quality and process performance (2 sides of the same coin) in CPV.
Toni Manzano, Chief Science Officer, Bigfinite
Toni Manzano is a co-founder and CSO of Bigfinite, a SaaS company that is transforming manufacturing operations with the use of AI and industrial Internet of things (IIoT) technologies for pharmaceutical and biotech companies. For over two decades, Manzano has led software projects for international pharmaceutical companies, covering the entire production process and supply chain. Today, Manzano is part of the scientific committee with PDA Europe and with the AI Xavier Manufacturing team. He worked as a researcher at the University of Barcelona as a physicist and teaches big data and artificial intelligence in postgraduate courses at UAB. He is also a member of the Science Experts in the Spanish Parliament on big data and artificial intelligence. Manzano has written numerous articles and holds a dozen international patents related to the encryption, transmission, storage and processing of large volumes of data for regulated environments in the cloud.Message Presenter
Raul Alba, PhD, PMP, Biotech Solutions Expert, Bigfinite
Raul Alba is a scientist and project manager with a great interest in the manufacture of biologics and advanced therapies (ATMP). He has a bachelor’s degree in Biotechnology and holds a PhD in Biochemistry and Molecular Biology from the Universitat Autònoma de Barcelona. He has participated in different projects as a postdoc at the University of Glasgow and he has written different publications concerning the biodistribution and genetic engineering of viral vectors. In addition, he holds different patents concerning new technologies for the development of novel tools for the gene therapy field. Alba has worked as Head of Virology and CMC Manager for the manufacture of different drug products concerning advanced therapies coordinating the manufacture with different CMOs for clinical trials.
Alba joined Bigfinite in 2020 as a Biotech Expert supporting the Product Development team to generate solutions which help pharma and Biotech companies to apply AI in their processes. He guides customers to acquire knowledge which accelerates the process development of their products and increase the efficiency of existing manufacturing lines.Message Presenter
Who Should Attend?
- Quality Assurance Managers
- Production Managers
- CIO, Chief Data Officers
- Regulatory Bodies
What You Will Learn
In this webinar, attendees will learn about:
- Strategy to apply AI in CPV
- Methodology to use AI as multivariate analysis in pharma
- Good practices to control processes in the Stage 3 of Process Validation
Bigfinite is a solutions provider that transforms manufacturing operations with the use of advanced analytics, artificial intelligence, and pharma 4.0 technologies focused on optimizing pharmaceutical and biotech companies. The Bigfinite analytics platform seamlessly integrates unlimited sources of structured and unstructured data to deliver actionable insights across all manufacturing sites. Bigfinite offers an intuitive way to gain meaningful operational intelligence with data by enabling real-time visibility and predictive insights in a GxP compliant manner with end-to-end data integrity. Founded in 2014, the company is based in San Francisco, California and also has a European office in Barcelona, Spain.