Category: <span>Manufacturing</span>

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

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

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

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

Cell substrates are used in various stages of viral vaccine manufacturing, as in the isolation, selection, and propagation of the virus seed or virus vector stock, as well as for the amplification of the virus to produce the final vaccine product. The various stages of cell substrate use, including cell banking, are shown in a generic manufacturing scheme in Figure 1. Traditionally, viral vaccines have been produced in animal tissues, primary cell cultures, and cell lines that either have a finite life span, such as normal diploid cells, or a theoretically infinite life span, as achieved with continuous or immortalized neoplastic cells. The cell substrates used in viral vaccines currently licensed in the US are listed in Table 1…

Manufacturing Viral Vectors

Monoclonal antibodies (mAb) are highly selective molecules, and an unlimited amount of mAbs with equal quality can be produced using mammalian cell cultures and animals. These molecules have remarkable applications in biomedicine, diagnosis and therapy due to the ability to reproduce exactly the same binding properties. The mAbs have been generated against an ostensible set of compounds such as toxins, drugs, blood proteins, cancer cells, viruses, hormones, environmental pollutants, food products, metals and plant materials. In general, mAbs can also be used for creating sensitive tests to detect small amounts of substances, and in therapies, abzymes, and for isolating specific compounds from complex mixtures by immunoaffinity chromatography (IAC)…

Manufacturing

Mass transfer is one of the most crucial parameters during scale-up in cell culture, and may cause variations in specific yields. At the cellular level, all the cells require proper supplementation of essential nutrient sources: nitrogen, oxygen, and carbon. The ability of cells to grow, maintain viability, and provide high specific productivity depends on the proper distribution of these nutrients. The latter depends on proper mass transfer to supply oxygen, carbon, and nitrogen through agitation and aeration, along with other micronutrients…

Manufacturing

Amino acids are the most basic of building blocks in physiology, which is why peptides (oligomers of amino acids) are continuing to grow in prominence among pharmaceutical manufacturers. With inherent abilities to block and/or enhance signal transfers in the human body, peptides, when harnessed as active pharmaceutical ingredients, can treat a host of metabolic diseases, cardiovascular and heart conditions, and neurodegenerative disorders. Peptide-based drug targets are being identified at an increasingly rapid pace, both in terms of recently introduced therapies, and products in the development pipeline…

Manufacturing

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

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