EMD Millipore, the Life Science business of Merck KGaA of Darmstadt, Germany, today introduced the Mobius® 2000 liter single-use bioreactor. The 2000 liter bioreactor joins the Mobius® stirred tank bioreactor portfolio (from 3 to 2000 liters) that provides the ultimate in flexibility, scalability, and convenience. With configurable software, hardware, and single-use Flexware® assemblies for suspension and adherent cell culture applications, the new 2000 liter single-use bioreactor incorporates industry-leading design features that enable users to easily optimize their upstream process. The…
Author Archives: BPI Contributor
Monoclonal Antibody Production: Viral Clearance and Host Cell Protein Reduction Using a High Capacity Single-Use Strong Anion Exchange Device
Strong anion exchange (Q) chromatography is an industry standard for polishing purification steps of mAb production. It is a proven technology which removes viruses, and host cell proteins from process feed streams in flow through mode. NatriFlo HD-Q devices adsorbers feature a hydrogel membrane which combines high dynamic binding capacity and salt tolerance to deliver best-inclass performance. This makes it possible to rapidly process large sample volumes using a small disposable device. This article examines the ability of NatriFlo HD-Q…
Natrix Introduces the Recon HD-Sb Hydrogel Membrane Ion Exchanger for Fast and Efficient Purification of Monoclonal Antibodies
Natrix Separations Inc., a maker of innovative single-use chromatography products for the biopharmaceutical industry, announced today the introduction of its HD-Sb chemistry, a salt-tolerant, strong cation exchange (sulfonic acid) membrane augmented with HIC (t-butyl) groups. The HD-Sb chemistry offers high dynamic binding capacity, even at elevated salt concentrations. The Recon HD-Sb is the first in a line of HD-Sb products to be commercially available. The Recon HD-Sb is a disposable device designed for laboratory-scale purification of monoclonal antibodies and other…
The Effect of Membrane Selection and Operating Parameters on Sterile Filtration of Hyaluronic Acid
Hyaluronic acid (HA)-based solutions are traditionally difficult to filter, due to their high viscosity. Many users have found sterile filtration of hyaluronic acid solutions very challenging to implement, from both an economical, as well as a practical standpoint. This White Paper evaluates commercially-available sterilizing-grade products for filtration of HA and explains how sterilizing-grade filters can offer a highly efficient, economical solution even under the worst-case bacterial challenge conditions. It outlines how the combination of various properties of HA-based solutions and…
Best Practices For Successful Filter Integrity Testing Using The Water Intrusion Test (WIT) Method
Hydrophobic filter cartridges which utilize sterilizing-grade polyvinylidene fluoride or polytetrafluoroethylene membranes are widely used in the pharmaceutical industry to sterilize compressed air or gases for product contact, as well as acting as sterile tank vents. However, hydrophobic membranes can also make filter integrity testing in situ difficult, as the membrane must be fully wetted prior to testing by the widely accepted integrity test methods of Bubble Point and Forward Flow. The Water Intrusion Test (WIT) is widely accepted within the…
Octane and Lonza Announce Exclusive Collaboration to Evaluate Groundbreaking Autologous Cell Therapy Technology
Lonza Group Ltd. in Switzerland and Octane Biotech Inc. in Canada have agreed to enter into an exclusive technology evaluation of the Octane Cocoonâ„¢ cell production platform for personalized cell therapy manufacturing with the goal of a global deployment of this groundbreaking innovation. Unlike current, labor-intensive production methods, the Octane Cocoon has the potential to enable the automated manufacturing of patient-specific cell therapies for maximum efficiency, traceability and scale-up. Under the terms of the agreement, Lonza will evaluate the Octane…
Caladrius Biosciences Announces First Patient Dosed in Phase 3 Immunotherapy Trial for Melanoma
Caladrius Biosciences, Inc. (Nasdaq:CLBS), a cell therapy leader with a late-stage clinical program for immuno-oncology, announced today the dosing of the first patient in the Intus Phase 3 clinical trial. The Intus trial is investigating the efficacy of the Company’s patient-specific targeted cancer immunotherapy candidate CLBS20 (also known as NBS20). The trial is studying CLBS20 in patients with stage III recurrent or stage IV metastatic melanoma. The patient was dosed (with either CLBS20 or control, in accordance with the randomized,…
Secondary Packaging: Creating Value with Product Lifecycle Management
with Daniela Guttmann and Susanne Hall Increasing regulatory requirements combined with the market pressure to develop patient-friendly drug delivery systems make product lifecycle management (PLM) a decisive field for today’s pharmaceutical and biotechnology companies. Their strategic service providers also are affected by those conditions. For example, as an internationally operating contract development and manufacturing organization (CDMO), Vetter reports an increasing number of life-cycle management projects with its customers in the past years. Learn more in this white paper from Vetter.…
DASGIP® Control is now DASware® control 5: Parallel Processing Advances Bioprocess Development
With DASware control 5 Eppendorf presents its revised software for benchtop bioprocess control. The updated graphical user interface provides intuitive process views, user-defined functions, and configurable charts. Thanks to a new database and core architecture users benefit from faster loading times even with big data sets. Functionalities of current DASGIP Control have been improved, such as parallel calibration procedures, comprehensive recipe management, and the seamless integration of offline analytical data. Flexible setpoint profiles enable process automation. The parallel design of…
Lonza to Expand Viral Therapy Business with Planned Construction of New Facility in Houston, TX
Lonza, a global leader in the field of viral and cell therapy manufacturing, announced today the planned expansion of its industry-leading viral gene therapy business. Lonza plans to construct a new 100,000 square foot facility for viral and immunotherapy development and manufacturing in the Houston, TX (USA) area, complete with a fully segregated fill/finish suite. This new facility will more than double Lonza’s capacity for the production of viral gene and virally modified therapeutics. The state-of-the-art multi-purpose facility is expected…