Bioprocess Alert

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.

Learn More

This video, produced by OSIsoft, features a brief discussion with Patrick T. O' Sullivan, Data Science Lead at Janssen in Cork, Ireland. During which he shares how Janssen is using the PI System to reduce the amount of time they spend doing data prep for their multi-million data point systems.

This video, which has 170,000+ views, utilizes a combination of animation and narration to explain the basics of Raman spectroscopy and the principles associated with application of the technology.

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

This video, produced by Saint-Gobain, explains the three steps commonly associated with the validation process; Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ). These processes, when combined, usually make up the foundation of a validation package.

This video, produced by Saint-Gobain, provides a concise definition of the practice of validation accompanied by a well-informed explanation that expands on the definition to provide an improved understanding to the associated principles and practices.

This video, which has 345,000+ views, explains the measurement principles behind the four most common approaches to the measurement of liquid flow; Mechanical, Magnetic, Vortex and Ultrasonic.

This video, which has 40,000+ views, uses a combination of illustration and narration to explains the principles and practices associated with gel electrophoresis.

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 8,000+ views, reviews the 3 pillars for maintaining a validated state. Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

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.

This video, which has 50,000+ views, was produced by the US FDA and uses animation supported by narration to provide an introduction to the practice of gene therapy.

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

This video, which has 5,000+ views, explains the functionality of a rotary pump by utilizing a narrated animation to demonstrate its operation.

This video discusses the basic principles for selecting an appropriate impeller for blending fluids in a stirred tank is an excerpt from the AIChE Academy eLearning Course "Fluid Mixing Technology for Operators".

This video, produced by Applikon, identifies the various bioprocessing challenges able to be addressed through the utilization of their DeltaV based V-Control solution. With an emphasis upon the suitability for seamless scalability from benchtop to production.

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 100,000+ views, is hosted by UCSF Professor Wallace Marshall. It features his "Top 10 List" of unexpected and amazing things that individual cells can do. These include growing to be huge, navigating mazes, and performing feats that seem to belong in science fiction.

This video, which has 25,000+ views, uses animation and narration to  explain the measuring principle of Pt100 thin-film sensors. It also provides hints for installation in the process and describes the evaluation of the signals using temperature transmitters and displays.

This video explains the differences between the two most common  curing methods of silicone tubing; platinum curing and peroxide curing. In so it provides the viewer with an improved understanding of the advantages and challenges to be found with each.

This video, which has 18,000 views, describes the various pressure relief solutions available to protect operators and process equipment alike.

This video by Mettler Toledo, which has 9,500+ views, shares the  three things you really should know about the recommendations  made in USP 41 for achieving good weighing practices.

This video, which as 12,000+ views, utilizes a series of highly informative slides to explain the principles and practices associated with upstream bioprocessing aspects of fermentation.

This video, which has 10,000+ views, explains the role of cell therapy and that which differentiates it from the other therapeutics.

This video, which has 40,000+ views, explains through a narrated illustration the principle of measuring level with vibration.

This video, which has 35,000+ views, explains how the oxygen concentration in a liquid can be measured using the amperometric or optical measurement principles.

This video, which has 80,000+ views, uses narration and illustration to explain how a pH electrode and meter work together to measure pH.

This video, which documents a Gene Therapy site build, provides insight into the role modular/prefabricated facilities are playing in the advancement of our industry.

This video, which has 40,000+ views, provides a helpful introduction to the principles and practices associated with measuring flow with a Coriolis meter.

This video, which has 165,000+ views, provides a narrated demonstration of proper procedure for cleanroom gowning in bioprocessing.

This video, which has 80,000+ views, explains the role of clinical trials in drug discovery.

This video, part 2 of 6, provides an introduction to the principles and practices associated with viral safety.

This video, part 1 of 6, provides an introduction to the principles and practices associated with viral safety.

This animated video, which has 295,000+ views, provides an explanation of normal phase vs reverse phase HPLC. Please note that while highly informative, there is no audio.

This video, which has 19,000+ views,  demonstrates why you cannot use geometric scale-up of a batch reactor with heat transfer.

This video, part 3 of a 4 part series, provides insights into the principles and practices associated with bioprocess validation.

This video, which has 160,000+ views, provides the principles and practices associated with aseptic gowning for work in a cleanroom.

This video provides insight into the reality of viral contamination and serves as an introduction to the principles and practices associated with viral safety.

This video, which has 20,000+ views, explains cell culture media and the components of culture media for cell growth.

This video, which has 8,500+ views, explains several methods for the separation of proteins.

This video, which has 69,000+ views, provides a highly informative explanation of the differences between aerobic and anaerobic processes.

This video, which has 123,000+ views, utilizes animation and narration to explain the various protein structures and the practice of folding.

This video, which has 320,000+ views, utilizes animation and narration to explain how gel electrophoresis functions to separate molecules by size.

This video, which has 77,000+ views, is hosted by Amgen's Sean Harper and discusses the future of biotechnology.