G-CON Manufacturing and Vanrx Pharmasystems have collaborated on the development of the Microcell POD. A fully integrated, pre-qualified, pre-installed aseptic filling facility comprised of Vanrx's Microcell Vial Filler installed inside G-CON's prefabricated cleanroom POD. The first of its kind offering requires a lead time of just 3 months and is able to be shipped globally. The Microcell POD is seen as ideal for drug development, and the manufacturing of personalized medicines and clinical trial supplies. Learn More
This technical note, authored by IDEX Health & Science, describes a novel, compact device, the Tridex Protein Analyzer, capable of rapid, automated at-line measurement of antibody titers from stirred bioreactors using an aseptic sampling device. Assay linearity and accuracy were evaluated over a measurement range of 0.1 to 6.5 g/L using a simulated cell culture titer curve spiked with bovine serum albumin (BSA) and human IgG. Manual and automated aseptic sampling measurements using the Tridex analyzer compared very favorably with a commercial Protein A HPLC system. Excellent intra-assay precision (CV < 3%) was demonstrated for both off-line and at-line measurements with the Tridex analyzer. Learn More
This video, produced by STERIS, walks the viewer through the equipment and processes required for successful gamma irradiation processing.
Standardization of Cell Viability Assays in Primary Cells as a Prerequisite for Novel Bioprocessing Applications
This video provides insights on the standardization of cell viability specific to bioprocessing applications with an emphasis on the requisite assays.
This video, produced by Hamilton Process Analytics, utilizes narration and animation to provide insights into the basics of pH measurement.
This article explores some of the advantages a QbD approach can bring to drug development programs and how it can ensure more robust commercial manufacturing methods for consistent production of quality medications. Quality by Design (QbD) brings a systematic approach to drug development that aims to ensure quality by applying analytical and risk-management methodologies to the design, development and manufacturing of new medications. At its core, the approach looks to design quality into workflows up front. Learn More
This video, produced by Sartorius, provides practical advice for those trying to develop and implement continuous processes. It explains the tools and techniques that can be used during process development and describe how process-scale equipment can be configured to allow effective and predictable scale-up.
This video, produced by Pall Biotech, provides some insights into orthogonal viral controls under continuous processing conditions.
This video, which has 120,000+ views, describes the process by which a biological product-in this case, a pure, concentrated solution of Green Fluorescent Protein (GFP)-is derived from clarified lysate. This is accomplished through multiple variations of two basic procedures: chromatography and filtration.
This video, which has 100,000+ views, describes the process by which a biological product-in this case, molecules of Green Fluorescent Protein (GFP)-is recovered from host e coli cells. The steps of this process are, in very basic terms: (1) separation of cell solids from the broth, (2) disruption of those host cells to release the product contained in them, and (3) isolation of the product through removal of cell debris and other impurities. Tools used to perform these steps include centrifuges, cell disrupters and microfilters.
This video, which has 300,000+ views, describes the role of the fermentation process in the creation of biological products and illustrates commercial-scale fermentation at a cellular level. Included are descriptions of types of fermentation; intracellular, extracellular, types of cells (aerobic, anaerobic), and cell nutrition/media.
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