biologics – BioProcessing Journal

Computational Analysis of Mixing Performance and Hydrodynamic Stress in a 30,000 L Bioreactor

Computational fluid dynamics (CFD) was used to evaluate how impeller type and vertical arrangement influence mixing performance and hydrodynamic stress in a nominal 30,000 L stirred-tank bioreactor operated at a 20,000 L working volume. Eight configurations containing different combinations of pitched-blade and Smith turbine impellers were simulated in COMSOL Multiphysics (v6.2) using the standard k-epsilon turbulence model. Mixing time, flow patterns, shear stress, and energy dissipation rate (EDR) were compared, and mixing-time mesh sensitivity was assessed using three mesh resolutions. Configurations with more pitched-blade impellers generally produced stronger axial circulation, shorter mixing times, and higher volume-average shear stress and EDR. The all-pitched-blade configuration mixed fastest, whereas the all-Smith configuration mixed slowest. Local maximum shear stress and EDR depended more strongly on impeller arrangement, and not predicted by vessel-average behavior alone. Comparison with a 3,000 L small-scale vessel showed that matching the selected impeller configuration and power input per unit volume (P/V) did not provide hydrodynamic equivalence. These results highlight the importance of evaluating impeller type, placement, and vessel scale together when balancing mixing performance and hydrodynamic exposure…

Biologics Production

biologics bioreactor impeller configuration CFD computational fluid dynamics EDR energy dissipation rate impeller configuration large-scale bioreactor mixing time monoclonal antibody production shear stress

Final Processing and Quality Evaluation of a Lentiviral Vector Reference Material

Lentiviral vectors (LVVs) are broadly used in research and therapeutic development, yet substantial interlaboratory variability continues to hinder the comparison of vector quantity, potency, and impurity measurements, underscoring the need for standardized reference materials. To address this need, the Lentiviral Vector Reference Material (LVVRM) initiative was launched as a structured, multi-phase effort, with earlier phases focused on large-scale upstream production and downstream preparation of a GFP-encoding LVV. In the final phase of the LVVRM initiative described herein, bulk material produced during prior large-scale manufacturing runs was thawed, pooled, subjected to sterile filtration, and dispensed into single-use vials under controlled conditions designed to maintain stability and consistency. Each lot then underwent comprehensive quality control testing. Sterility, identity, purity, physical and functional titers, and safety attributes were assessed using established characterization frameworks appropriate for lentiviral vector reference materials. The resulting LVVRM (ATCC® VR-3382™) met quality standards and release criteria, providing a well-characterized reagent suitable for assay calibration, method qualification, and longitudinal performance monitoring across laboratories.

Biologics Production

biologics fill-finish lentiviral vector lentivirus standard LVV-RM LVVRM qc quality control reference material

From the Publisher: Big Companies Have Lots of Money — Just Not for Operations

M&As continue at a dizzying pace even while so many organizations are just trying to hang on. Apparently some of the biggest firms still have excess money or access to cheap money, and they would rather spend it acquiring than building or solidifying what they have. But if they have so much money, why are they laying so many people off? At a biotech business meeting I recently attended in DC, I kept hearing that “companies have a lot of money.”
But when I followed-up on this point with a panelist, I was told that much of this money could not be used for
operations. Apparently because of the off-shore location, or other locations where it’s hiding, it can only be used to buy stock…

Biologics Production

biologics business acquisitions investment banker deals m&a mergers and acquisitions spin-offs technology transfer

From the Editor-in-Chief: Where’s the Value in These Never-Ending M&As?

I’ve seen little to tell me the major biopharma firms, or the larger supply firms, have learned anything. They’re stuck on the concepts of slashing vital resources—such as R&D and capacity—to “do deals” plus pay executive
bonuses, investment bankers, and hordes of attorneys. As a result, we’ve seen a burgeoning of Business-to-Business (B2B) meetings where the talks are geared toward selling companies and acquisition services. So we continue to see these large firms hoarding cash, acquiring companies, and cutting strategic resources…

Biologics Production

biologics bioproduction business acquisitions equity building investment banker deals m&a mergers and acquisitions

From the Editor-in-Chief: I Still Don’t Like Calling Biopharmaceuticals “Drugs”

When I go to a therapeutic protein meeting, it’s very hard for me to hear these products referred to as “drugs.” But since they are being regulated by CDER, it’s a little easier to swallow. However, calling viral gene vectors and cellular therapies “drugs” is a bridge too far. My advice to my good friends at CBER is to keep calling their products “biologics,” or they may lose all of their regulatory responsibilities to CDER…

Biologics Production

biologics bioproduction cber cder cellular therapies drug product FDA monoclonal antibodies odat regenerative tissues subunit vaccines viral gene vector

From the Editor-in-Chief: Many of the Toughest Biologicals are Becoming Easier to Produce

There are so many exciting things happening in the biotech industry. As we have all seen, antibody products are being approved for more and more cancer applications, in addition to those for auto-immune diseases, which used to dominate how they were being used. And of course, these applications are in addition to the many which use antibodies conjugated to chemotherapeutic drugs and imaging agents—where the antibody acts as a targeting mechanism. Then there are the hundreds of monoclonal and polyclonal antibody applications that have dominated diagnostic testing for decades…

Biologics Production

aav adeno-associated virus air handling antibody conjugates biologics bioproduction cryopreservation diagnostic testing ind investigational new drug lentiviral vector systems monoclonal antibodies polyclonal antibodies regenerative tissues subunit vaccines transient transfection viral gene vectors

From the Editor-in-Chief: Production Technology for Lentiviral Vectors

I’ve had some very interesting technical issues cross my desk in the last month, and one involves the “state-of-the-art” production technology for lentiviral vectors. And while you’d think this process should be quite advanced since the industry has been manufacturing viral gene vectors for over 20 years, it appears that we’ve fallen back on old technology and we’re dealing with processing issues we would typically avoid…

Biologics Production

attachment-dependent production biologics bioproduction fbs fetal bovine serum hek 293 cells hek 293T human embryonic kidney lentiviral vector systems packed bed bioreactor stable cell lines sv40 t antigen viral gene vectors

From the Editor-in-Chief: Major Successes in the Industry and Primary Challenges That Follow

As biologics continue to advance at a dizzying pace, I want to take this opportunity to outline what I see as the major successes, as well as the primary challenges facing the industry. First, the science of antibody production appears to be quite settled. Significant value can be gained by finding ways to limit production batches to volumes that can be accommodated by single-use bioreactor systems…

Biologics Production

biologics bioproduction cellular therapies continuous downstream processing cryopreservation challenges downstream purification monoclonal antibodies personalized medicine real-time data scale-out scale-up single-use equipment viral gene vectors

From the Editor-in-Chief: A “Renaissance” of Sorts Within the Biologics Industry

We just completed our 6th ISBioTech Spring Meeting, and it was a resounding success. And while the attendee numbers were up considerably, the more important aspects for me were that we had the “right” people, plus incredibly valuable content. Then what impressed me the most was the happiness and hopefulness I saw during the meals, receptions, and the banquet. We’ve been organizing these meetings for over 20 years, and I haven’t experienced anything like this since our earliest days in Williamsburg…

Biologics Production

aav adeno-associated virus baculovirus expression technology biologics bioproduction car t-cells chimeric antigen-receptor expression systems hpv vaccine internal reference materials mab monoclonal antibodies rhabdovirus sf9 cells therapeutic cancer vaccines vaccine development vaccines

From the Editor-in-Chief: Biomedical Research and Biopharmaceutical Advances in Cuba

European organizations have been doing business with Cuba during its last 30 years of biotechnology development, and have benefited from both licensing and distribution agreements for generic pharmaceuticals, as well as vaccines and other biologicals. However, as far as direct US/Cuban interactions, we’ll probably have to go through a period of “low-level” scientific exchanges before there is much interaction. As a starting point, it has been proposed by the American Association for the Advancement of Science (AAAS) that an official scientific and technology agreement be established to form a broader framework for interactions…

Biologics Production

biologics bioproduction cigb cuba expression systems herber biotec mab monoclonal antibodies polyclonal antibodies therapeutic cancer vaccines tropical diseases vaccine development vaccines

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