BioProcessing Journal

Storage and Transportation of Biological Materials: The Importance of a Sample Management Plan

Biological samples such as human tissue, cell lines, and serum specimens are a direct source of molecular data that can be used to identify targets for disease therapy, detection, and prevention. However, the validity and reliability of data derived from burgeoning analytical technology is highly dependent upon properly preserved, well-annotated biospecimens. As a result, biopreservation and biobanking have become an increasingly integral component in advancing today’s biotherapeutic development…

Cell & Tissue Banking Risk Analysis and Management

biobanking biopreservation cold chain shipping preanalytical variations sample management plan temperature-monitoring devices

The Effects of Temperature Variation in the Bioethanol Production Process

Fermentation utilizes organic substrates and organic electron acceptors to produce reduced organic substances as end-products. Bioethanol has a number of advantages over conventional fuels because it is produced from renewable resources. Ethanol is a high octane fuel that can replace lead as an octane enhancer in petrol by helping to oxygenate the fuel mixture so it burns more completely and reduces polluting emissions. The burning of ethanol more closely represents a natural carbon dioxide cycle since the released CO2 is recycled back into plants where the carbon dioxide becomes the carbon source for new sugars, starches and cellulose…

Manufacturing

bioethanol fermentation optical density spectrophotometry temperature variation

Found Money: Tax Credits and Incentives Can Offset Research Costs

How much new business does it take to add $100,000 or even $1 million to the bottom line? Even with tax deadlines looming for companies that filed extensions, there is still time to maximize the benefits of all available tax credits and incentives. A powerful tax incentive known as the research and development (R&D) tax credit is available in the United States at both the federal and state levels to help manufacturers recover a significant amount of R&D costs…

Manufacturing Research

cost reduction research and development tax credit tax incentive

FANG Vaccine: Autologous Tumor Cell Vaccine Genetically Modified to Express GM-CSF and Block Production of Furin

Based on our previously published TAG vaccine design and the TAG vaccine clinical results to date (which demonstrate safety and evidence of efficacy — stabilizing disease plus one confirmed complete response; data submitted elsewhere), we have moved forward with a fundamentally new autologous tumor cell vaccine design incorporating a key technical enhancement through our proprietary bifunctional shRNA technology. The resulting FANG vaccine expresses both recombinant human GM-CSF protein and a furin bifunctional shRNA which blocks the expression of furin protein, and then in turn, significantly reduces the expression of both TGFß1 and TGFß2 in all primary human tumors tested to date…

Biologics Production

autologous cancer vaccine autologous tumor vaccine production furin bifunctional shRNA nonviral vector system vaccines

Kinetic of Expression Study of the Hepatitis B Surface Antigen in Pichia pastoris

In general, yeasts offer advantages for recombinant protein expression because their intracellular environment is suitable for the correct folding of recombinant proteins and grow very high cell densities in defined fermentation media. Within the yeast kingdom, Pichia pastoris has been successfully used for expressing several recombinant proteins. The genome of this yeast contains two copies of the alcohol oxidase (AOX) gene, where the AOX1 promoter regulates 85% of the alcohol oxidase activity and drives the recombinant protein expression into the cell. One of the most successfully recombinant proteins expressed in Pichia pastoris is the hepatitis B surface antigen (HBsAg). The current manufacturing process of the active pharmaceutical ingredient (HBsAg) of the Cuban hepatitis B vaccine (HeberBiovac™ HB) starts with the expression of the HBsAg in Pichia pastoris….

Biologics Production

antigen expression fermentation hepatitis B surface antigen kinetic of expression process optimization protein expression recombinant proteins

Downstream Factors That Will Continue To Constrain Manufacturing Through 2013

Downstream processing is increasingly seen to be a capacity constraint for many biopharmaceutical manufacturing organizations. In our current study, nearly 75% of respondents reported that their facilities were experiencing some degree of capacity bottlenecks as a result of downstream processing. In comparison, 63.8% responded the same in the previous year. As the biopharmaceutical industry increases its focus on cost containment, product pricing, and healthcare reform, critical manufacturing operations have been pushed to center stage. Over the past few years, downstream processing, which includes complex operations such as filtration of final products and chromatography operations has become increasingly challenging, from budgetary and operational perspectives. As upstream operations continue to improve, the ability of current downstream facilities to handle the additional load has led to strains and constrictions. The industry is open to new solutions although few alternatives to current processes have been presented. A number of promising innovative technologies are on the horizon, but it will be a few years or more before they debut in clinical or commercial production operations….

Manufacturing

capacity constraints chromatography column chromatography downstream processing membrane technology purification

Protocol Development for Vitrification of Tissue-Engineered Cartilage

The success of tissue-engineered cartilage constructs (TECCs) as treatment options for healing cartilage defects can only be achieved if suitable preservation methods are found that can maintain their viability and function. Simply lowering the temperature of cells and tissues to below their freezing point invariably destroys them due to ice crystals that form in the water-laden cells and tissues. In addition, high salt concentrations that result from removal of water due to ice formation create a toxic imbalance. If the formation of ice crystals can be minimized while still halting metabolic activity of cells at low temperatures, then the viability and functionality of the preserved tissue may be maintained…

Biologics Production

cell viability cryopreservation cryoprotectants tissue engineered products tissue-engineered cartilage constructs vitrification

Monitoring Viable Cell Density in Bioreactors Using Near-Infrared Spectroscopy

Viable cell density (VCD), the quantitative assessment of living cells, is commonly determined by laborious and inaccurate off-line cell counting methods. Single-function in situ probes have been developed using various technologies including optical density, radio frequency and dielectric permittivity. Optical density measurements predict total biomass but are sensitive to cell debris accumulation and inherent media turbidity. Near-infrared (NIR) has the advantage of being able to measure many key analytes in the cell culture simultaneously. NIR has been used to acquire real-time measurements of glucose, glutamine, glutamate, and media nutrients such as amino acids and metabolites (e.g., lactate and ammonia). NIR probes can be sterilized in place, and real-time measurements can be acquired throughout the mammalian cell culture processes…

Biologics Production

bioreactor mammalian cell culture near-infrared spectroscopy process monitoring viable cell density

Optimized Protein Yields from Lotus Seed Utilizing CO₂ Pressure Preparation and Ultrasound-Assisted Extraction

The lotus (Nelumbo nucifera) is a fresh-water plant that grows in semitropical climates. It is cultivated extensively in Asian countries, particularly in China. Besides its popularity as an ornamental flower, it is also used as an herbal medicine, mainly in China, Japan, and India, and it displays strong antipyretic, cooling, astringent, and demulcent properties. Lotus seed is widely used as a food in China. Lotus seed is rich in protein, amino acids, unsaturated fatty acids, and has adequate amounts of essential minerals such as potassium, calcium, magnesium, and iron, without heavy metal contamination. As a protein source, the crude protein of lotus seed is higher than parboiled rice (7.70%) and wheat (8.55%). Unlike legumes, lotus seed possesses adequate sulfuric amino acids (methionine + cysteine), comparable to the FAO/WHO and soybean reference patterns. The high content and high quality of protein in lotus seeds emphasizes their value as a vital source of nutrients…

Biologics Production Manufacturing

isoelectric protein precipitation protein extraction protein extraction yield protein precipitation yield salt extraction ultrasound-assisted extraction volatile acid

Cell Culture Bioreactor Optimization: Growing Recombinant HEK293 Cells to Produce a G-Protein-Coupled Receptor (rGPCR) Membrane Protein

Heterologous expression of membrane proteins remains a bottleneck for structural characterization by x-ray crystallography. Such proteins represent approximately 30% of the proteome and are not sufficiently represented in the Protein Data Bank (PDB). G-protein-coupled receptors (GPCRs) are an area of particular interest as it is estimated that one third of current FDA approved drugs act through this class of receptors. We have been studying rhodopsin with an interest in determining the conformational change that leads to signal transduction in this class of receptors. Although there has been some success in expressing select members of the large GPCR family in bacterial systems, the best characterized expression systems have generally been in mammalian tissue culture…

Biologics Production

cell culture bioreactor G-protein-coupled receptors membrane proteins protein expression recombinant proteins stirred-tank bioreactor

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