Upstream processes are one of the most evolving technologies available for the production of medicinal products. There is a constant need to upscale medicinal products from a few liters to thousands to cover population needs anywhere from chemical entities and recombinant proteins to different types of antibodies or viral vaccines (like COVID-19)… and these are just some examples. The urgency for creating safe, efficient and quality vaccines for critical situations, such as COVID-19 in the near term, must be exhaustively produced and controlled with the support of mechanisms like augmented intelligence.
The systematic application of AI orchestrating the complexity associated with vaccine manufacturing leads to better knowledge and allows operators to act quickly before potential anomalies can occur, thereby improving drug safety and manufacturing process. Controlling all of the process parameters can be difficult and very time consuming for process development or pharma teams due to the large amount of data registered in real time. Pharma companies often lack the technology to measure all the variables to pay close attention to all critical factors which could directly or indirectly affect the safety, the potency, the impurity profile and the quality of medicinal products. In addition, working with biological entities in bioreactors implies a real challenge for modern manufacturing since critical process parameters and critical factors inherently present high variability in these systems. For this reason, the acquisition of real-time knowledge is increasingly necessary in continuous manufacturing to avoid process deviations which could lead to low efficiency or rejected batches.
In this webinar, join Toni Manzano and Raul Alba as they show what useful aspects to monitor in upstream processes, detect early deviations using AI algorithms and discuss classical statistical analysis and advanced analytics using AI tools. The presenters will show how easy it can be to perform root cause analysis of possible deviations and convert data into knowledge so that challenging scenarios can be predicted and avoided before they occur.
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?
- Pharma Manufacturing
- Manufacturing Operations
What You Will Learn
In this webinar, attendees will learn about:
- How multivariate analysis can help detect deviations early in upstream processes
- What kinds of actions can be taken before a multivariate deviation occurs
- What tools are available to understand the root cause of possible outliers
- Whether scenarios can be predicted in upstream processes
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.