BioProcessing Journal

Testing Strategies for Mammalian Cell Banks

Contamination by adventitious agents (bacteria, fungi, mycoplasma, and viruses) represents potential safety risks for biologics produced in mammalian cells. Bacterial and fungal contaminations are usually easy to detect in culture medium due to changes in pH and visual indicators such as color and opacity. Mycoplasma contamination has been detected in 15–35% of cell lines deposited in some cell culture collection. This is because mycoplasma contaminations often cause little changes that can be readily detected by visual inspection. However, bacterial, fungal, and mycoplasma contamination can be more effectively controlled than viral contamination by careful screening of initial parental cell banks, proper environmental monitoring, along with ongoing testing…

Cell & Tissue Banking

contaminant control mammalian cell culture raw materials qualification safety testing viral clearance viral contamination

Preparation of Haemagglutinin-lgG1 Fc Fusion Proteins in Insect Cells and Evaluation as Influenza Vaccines

ImmBio’s lead development candidate is an influenza vaccine based on the ImmunoBody® platform technology. An ImmunoBody is a fusion of a selected immuno-dominant antigen with a cell-binding domain — the Fc fragment of human IgG1. The use of recombinant Fc fusion proteins is well documented where it can help solubilize hydrophobic proteins, provide a handle for easy detection and purification, as well as improve half-life…

Baculovirus Expression Technology Biologics Production

BEVS influenza insect cell technology recombinant hemagglutinin proteins vaccines

TAG Xenograft Vaccine: Xenograft-Expanded Autologous Tumor Vaccine Genetically Modified to Express GM-CSF and Block Production of TGFβ2 (part 1)

Preliminary studies with a variety of cell-based vaccines suggest target accessibility (potential immunogenicity) to immune-directed approaches in a variety of solid tumors. However, four primary factors limit the generation of effective immune-mediated anticancer activity in therapeutic applications: 1) identifying and/or targeting cancer-associated immunogen(s) (target) in an individual patient; 2) insufficient or inhibited level of antigen-presenting cell (dendritic cell, macrophage) priming and/or presentation; 3) suboptimal T cell activation (potency) and proliferation; and 4) cancer-induced inhibition of the anticancer immune response in both afferent and efferent limbs…

Biologics Production Manufacturing

anticancer immune response autologous tumor vaccine production autologous vaccine gene transduced cell vaccine vaccines

TAG Vaccine: Autologous Tumor Vaccine Genetically Modified to Express GM-CSF and Block Production of TGFβ2 (part 2)

We have designed a novel autologous vaccine by combining two vaccine strategies that have each been previously tested in separate non-small cell lung cancer (NSCLC) clinical trials: 1) a GM-CSF gene transduced tumor cell vaccine; and 2) a TGFβ2 antisense gene transduced cell vaccine. Each has demonstrated similar beneficial effects without any evidence of significant toxicity in advanced cancer patients…

Biologics Production Manufacturing

anticancer immune response autologous vaccine cell viability gene transduced cell vaccine vaccines

Tangential Flow Filtration Membranes For the Washing of Escherichia coli Cells

Microbial fermentation is used to produce such products as therapeutic proteins, antibiotics, hormones, enzymes, amino acids, blood substitutes and alcohol. These products may be expressed by the microbial cells themselves, expressed intracellularly in the cytoplasm or, in the case of bacterial cells, in the periplasmic material. Before any intracellularly-produced molecules can be used and further purified, the cells (i.e., E. coli) must be concentrated and set in an appropriate buffer (cell washing) before being lysed. Then after lysis, molecules of interest have to be separated from the parent cells and then clarified to remove cellular debris and other contaminants. Depending on the process used, additional clarification steps may be necessary…

Biologics Production

cell washing concentration diafiltration microbial fermentation tangential flow filtration

Tracking Pipetting Performance in the Primeval Wilderness of the Pacific Northwest (Extreme Pipetting Expedition #4)

Fresh on the heels of Mission #3 at the stiflingly hot Death Valley National Park, the ARTEL Extreme Pipetting Expedition team looked forward to visiting the temperate and humid Olympic National Park. Known for its lush, rainforest-like conditions, Olympic is home to 266 glaciers, more than 60 miles of rugged Pacific coastline, and over 140 inches of rainfall each year. It also has the Northwest’s largest remaining acreage of undisturbed rain forests…

Research

data integrity evaporation humidity pipetting volume variation

Death Valley Days: The Impact of Dry Heat on Laboratory Data (Extreme Pipetting Expedition #3)

As the ARTEL Extreme Pipetting Expedition team set out for Mission #3, only one thing was certain — it was about to get much hotter. Heading to Death Valley National Park in the desert spanning Nevada and California, the Expedition’s goal was to test the effect of dry heat on pipetted volumes. As the sun beat down and the temperature rose, the cold temperatures of Mt. Washington (Mission #1) and the mild climate at Yellowstone National Park (Mission #2) seemed like distant memories to the Expedition team…

Research

aridity calibration data integrity evaporation humidity pipetting volume variation

Developing Lifeline™, a Small-Caliber Autologous Tissue-Engineered Blood Vessel, for Clinical Trials in Germany

A considerable clinical need exists for alternatives to the autologous vein and artery tissues used for vascular reconstructive surgeries such as coronary artery bypass graft (CABG), lower limb bypass, arteriovenous shunts, and repair of congenital defects to coronary circulation. So far, devices made from synthetic materials have not matched the efficacy of native grafts, particularly in small diameter applications. Recent advances in cell biology and tissue engineering have introduced the possibility of a living, biological graft that might mimic the functional properties of native vessels…

Biologics Production Regulatory

autologous biological graft clinical trials sheet-based tissue engineering tissue engineering tissue-engineered blood vessel vascular reconstructive surgery

The Establishment of a Documentation System and Quality Control Strategy for the Plantibody HB-01 Production Employed in rHBsAg Purification for Pharmaceutical Use

Regulatory agencies routinely announce changes in the GMP (Good Manufacturing Practices) norms and quality standards designed to guarantee that every product retains characteristics required for its pharmaceutical use.The alignment with emerging regulatory requirements is mandatory, therefore, to assure production process consistency, as well as the safety and efficacy of the finished product…

Biologics Production Regulatory

documentation GMP immunopurification plantibody quality control transgenic plants

Expression Vector Engineering for Protein Production in Mammalian Cells

Incorporating a genomic regulatory sequence element can help to develop a robust expression vector, leading to improved recombinant protein expression in cultured cells. Such elements include the Expression Augmenting Sequence Element (EASE), scaffold- or matrix-attachment regions (S/MAR elements), Insulators, or the Universal Chromatin Opening Element (UCOE). However, generating a robust vector further requires having the relevant vector components in a context-optimized manner…

Biologics Production

chromatin remodeling elements eukaryotic gene regulation expression vector engineering genomic regulatory sequence element promoters protein expression

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