In this video, produced by OSIsoft, Poul Waagner Nielsen, Project Manager, Manufacturing Intelligence, at LEO Pharma describes using the PI System as a central warehouse of production data for the people and manufacturing systems in their six factories spread across Europe. Learn More
This 20-page white paper provides a comprehensive,
but accessible, overview of requirements and recommendations related to the U.S. FDA's Process Analytical Technology (PAT) initiative for the biopharmaceutical industry.
- Understand critical process parameters (CPPs), critical quality attributes (CQAs), and key performance indicators (KPIs) for fermentation control in the bioreactor.
- Know which CPPs and KPIs are the most reliable to efficiently monitor your process.
- See the most recent examples of PAT applied in the biopharma industry and R&D.
The titer of an antibody being expressed in a stirred bioreactor is usually measured offline using a process that involves removing an aliquot aseptically from the bioreactor, centrifuging the aliquot, and analyzing the resulting supernatant. The supernatant is analyzed either by bio-layer interferometry (BLI), Protein A HPLC, or ELISA. Such an approach may limit throughput, workflow, and efficiency. Aragen evaluated a prototype chromatography-based device that is directly connected to a bioreactor. Learn More
The logistics of decoupling drug substance manufacturing from final drug product formulation is now possible using integrated single-use freeze-thaw assemblies which incorporate reliable components. In this white paper we will explore how freezing the biological material in single-use assemblies has been enabling technology for managing the logistics. Learn More
This video features an interview with Erik Klijn, Senior Data Analytics Lead, at Janssen. During which he discusses the deployment of an OSIsoft PI system to conduct advanced analytics in biopharma manufacturing. This includes an application where the PI system is used to analyze the impact of raw materials on bioreactor performance.
This video, which has 5,000+ views, was produced by the U.S. FDA to explain the concept of interchangeability. The video features an interview with Leah Christl, Ph.D., former Associate Director for Therapeutic Biologics and lead of the Office of New Drugs (OND) Therapeutic Biologics and Biosimilars staff at FDA CDER.
This video, which has 10,000+ views, was produced by the U.S. FDA to address the question of "What are biosimilar products?" The video features an interview with Leah Christl, Ph.D., former Associate Director for Therapeutic Biologics and lead of the Office of New Drugs (OND) Therapeutic Biologics and Biosimilars staff at FDA CDER.
In this white paper, Colder shares how t he logistics of decoupling drug substance manufacturing from final drug product formulation is now possible using integrated single-use freeze-thaw assemblies which incorporate reliable components. They explore how freezing the biological material in single-use assemblies has been enabling technology for managing the logistics. Learn More
In this video, Kristin O'Neill of Merck & Co. describes how in a PD environment the OSIsoft PI System tracks both bioreactor controller data and automated sampling system data. Merck scientists no longer have to open up their notebooks when they want to compare sample analysis against bioreactor information.
This video, by the AIChE Academy, demonstrates the three regimes of gas mixing in a bioreactor; Flooded, Dispersed, and Recirculation and the methods used to achieve each.
This video, which has 18,000+ views, demonstrates how to prepare an ultralight foam from cross linked gelatin, which can be used to keep cells alive for up to a week at room temperature. No incubator, CO2, dry ice or liquid nitrogen required. The material is easy to make and prepare and the method works for both adherent and suspension cells.
This video, which has 7,000+ views, discusses the use of four electrode conductivity sensors in applications that require a wide measuring range such as fermentation and chromatography. Learn More
This video, which has 30,000+ views, explains anaerobic respiration including the two types of fermentation. Learn More
This video provides an explanation of Protein A and its importance to modern bioprocessing. Learn More