Biotechnology,people and markets

In assessing the likely demand for biotechnology products it is not sufficient just to look at what is happening in firms and their immediate market environment. There is no one 'market' for biotechnology products: there are differences between sectors and between countries. You have instead to look at the institutional contexts of the biotechnology product's development. This paper reviews work which has been carried out by social scientists, especially those using 'social shaping' approaches, on the development of new products based on advances in biotechnology and on the creation of markets to go with these products. It examines work on public attitudes to the exploitation of the technology, focusing especially on the issue of social inclusion and exclusion and how biotechnology might make exclusion more likely. It concludes by considering what current differences in public attitudes to the development of some biotechnology-based products might mean for the development of markets for those products in the UK.     

White biotechnology: ready to partner and invest in

It needs three factors to build an industry: market demand, product vision and capital. White biotechnology already produces high volume products such as feed additive amino acids and specialty products like enzymes for enantioselective biocatalysis. It serves large and diverse markets in the nutrition, wellness, pharmaceutical, agricultural and chemical industry. The total volume adds up to $ 50 billion worldwide. In spite of its proven track record, white biotechnology so far did not attract as much capital as red and even green biotechnology. However, the latest finance indicators confirm the continuously growing attractiveness of investment opportunities in white biotechnology. This article discusses white biotechnology's position and potential in the finance market and success factors.     

高通量微型生物反应器的研究进展

近年来,哺乳动物细胞培养技术发展迅猛,基于此技术的生物制药行业更是异军突起。在激烈的生物药市场竞争中,缩短研发时间和降低研发成本是制胜的关键。与传统的生物反应器相比,高通量微型生物反应器具有操作简单、运行通量高、实验重复性好等优点,可大大缩短研发周期,降低人力、物力成本,因此成为了生物制药行业最新的研究热点之一。目前,已成功应用于生物药物研发的微型生物反应器有Simcell ^TM、Ambr 15 ^TM、Ambr 250 ^TM等,分别适用于工艺开发中的不同阶段。以上述三种微型生物反应器为例,介绍高通量微型反应器在哺乳动物细胞培养工艺开发中的研究现状及发展前景。     

Green Niche Market Development

This article introduces a multiagent simulation framework for investigating the emergence of niche markets for environmentally innovative products. It clarifies how consumer preferences, business strategy, and government policy interact during market development. The framework allows investigation of the effects of uncertainty and agents' corresponding coping strategies. We describe the model, illustrate how it works when applied to the case of hybrid cars, and analyze results spanning several policy cases and a range of scenarios that make different assumptions about the heterogeneity of agents. Heterogeneity within each agent class strongly influences aggregate outcomes. Innovative firms can create green products in response to or in anticipation of government regulation, but true green niche markets do not emerge unless there are also green consumers. Niche markets do not go mainstream unless scale economies drive costs down to parity with conventional products. Preferred environmental innovation policies change with heterogeneity assumptions.     

Local,regional and global markets: what drives the tuna fisheries?

Tuna products are amongst the most popular seafoods in the world and widely traded across the globe. Their global trade developed at a very early stage in the growth and development of tuna fisheries. In this article, recent evolutions of tuna markets in terms of products (for both sashimi and cannery-grade tuna products), market structures, and trade are introduced followed by a comprehensive study of global integration through price linkages. Most studies show a high degree of market integration and competition through prices at the world-wide level. Finally, we introduce some original results about the relationship between catches and prices (estimated coefficients of demand elasticity and flexibility), and provide answers to a few key questions for tuna fisheries and markets, including: How do consumers respond to price changes? Are fish price changes fully transmitted to consumers? Is there any economic incentive for fishers to comply with reduced catch quotas? Do fishers target particular tuna species according to the relative price of tuna species?     

Development of arbuscular mycorrhizal biotechnology and industry: current achievements and bottlenecks

Advanced scientific knowledge on arbuscular mycorrhizal symbioses recently enhanced potential for implementation of mycorrhizal biotechnology in horticulture and agriculture plant production, landscaping, phytoremediation and other segments of the plant market. The advances consist in significant findings regarding:—new molecular detection tools for tracing inoculated fungi in the field;—the coexistence mechanisms of various fungi in the single root system;—new knowledge on in vitro physiology of the AM fungi grown in root organ cultures;—mechanisms of synergistic interactions with other microbes like PGPR or saprotrophic fungi; discovery of mycorrhiza supportive compounds such as strigolactones. Scientific knowledge has been followed by technological developments like novel formulations for liquid applications or seed coating, mycorrhiza stimulating compounds or new application modes. Still the missing components of biotechnology are appropriate, cheap, highly reproducible and effective methods for inocula purity testing and quality control. Also there is a weak traceability of the origin of the mycorrhizal fungi strains used in commercial inocula. Numerous poor quality products can still be found on the markets claiming effective formation mycorrhiza which have very low capacity to do so. These products usually rely in their effects on plant growth not on support of host plants via formation of effective mycorrhizal symbiosis but on fertilizing compounds added to products. There is growing number of enterprises producing mycorrhiza based inocula recently not only in developed world but increasingly in emerging markets. Also collaboration between private sector and scientific community has an improving trend as the development of private sector can fuel further research activities. Last but not least there is apparent growing pull of the market and increasing tendency of reduction of agrochemical inputs and employment of alternative strategies in planting and plant production. These circumstances support further developments of mycorrhizal inocula production and applications and maturation of the industry.     

Guardians at the gate

Product life cycle management, which necessarily utilizes a multi-disciplinary approach, is an essential tool for companies that develop or market therapeutic monoclonal antibodies (mAbs). Too little attention to such a plan, or use of the wrong resources, could substantially curtail a product’s life span. The most difficult part of the therapeutic antibody business is the development of high-quality, safe and effective products. Great care should thus be taken to ensure that products with these characteristics are positioned in a marketplace that is competition-free for as long as possible. In an era of mAbs with billion dollar markets, the loss of even a single day of sales could cost companies millions of dollars in lost revenue.     

Biosimilars: navigating the regulatory maze across two worlds

The impending loss of market exclusivity for established biologic products creates a lucrative market opportunity for biosimilars. However, complex and variable regulatory requirements between regions present challenges to developers. Understanding the regulatory differences between two major markets, Europe and China, will expedite entry into these key markets.     

Review: Enzyme applications for agro-processing in developing countries: an inventory of current and potential applications

The use of enzymes has the potential to increase productivity, efficiency and quality output in agro-industrial processing operations in many developing countries. Enzyme-catalysed processes generally have requirements for a simple manufacturing base, low capital investment and consume relatively small amounts of energy, when compared with other methods of food processing.This review presents an inventory of current and potential areas in which the use of enzymes may expand and diversify markets for agricultural products, facilitate agro-industrial development, improve nutrition, and reduce toxicity in foods produced and consumed in developing countries.     

COMMERCIAL DEVELOPMENTS IN MICROALGAL BIOTECHNOLOGY

A number of important advances have occurred in microalgal biotechnology in recent years that are slowly moving the field into new areas. New products are being developed for use in the mass commercial markets as opposed to the "health food" markets. These include algal-derived long-chained polyunsaturated fatty acids, mainly docosahexaenoic acid, for use as supplements in human nutrition and animals. Large-scale production of algal fatty acids is possible through the use of heterotrophic algae and the adaptation of classical fermentation systems providing consistent biomass under highly controlled conditions that result in a very high quality product. New products have also been developed for use in the development of pharmaceutical and research products. These include stable-isotope biochemicals produced by algae in closed-system photobioreactors and extremely bright fluorescent pigments. Cryopreservation has also had a tremendous impact on the ability of strains to be maintained for long periods of time at low cost and maintenance while preserving genetic stability.     

Implications of Livelihood Dependence on Non-Timber Products in Peruvian Amazonia

The present and future well-being of the world’s forest dwelling populations depends on their ability to gain livelihood resources from their immediate environment. Sustainable extraction of non-timber forest products has been promoted by conservationists and development agencies as a feasible strategy for forest dwellers that does not compromise the resource base. Yet surveys of actual resource use suggest that for poorer resource-dependent communities without access to markets, non-timber forest products can only ever represent a safety-net activity and a supplementary income source. Others argue that resource availability, in terms of the diversity and productivity of the forest, is the key parameter in realizing a contribution of forest products to well-being. This paper examines the scope and heterogeneity of forest product use to reveal whether resource availability necessarily provides the context for significant contributions to well-being of forest dwellers. We present data from an area of tropical rainforest, close to Iquitos in Peru, which was previously shown to have high potential value. We find, through a census survey of households within a forest reserve area, that non-timber forest products provide only a relatively small portion of income and that only a small proportion of available products are actually commercialized, despite apparent market availability. We show that the low rates of commercialization can be explained by unequal access capital assets used for extraction, to natural resources themselves, and to product markets. They are also explained by the concentration of capital-poor households on subsistence gathering activities. The value of destructive uses of forests, both logging and agriculture, remain higher than returns from non-timber products. This research demonstrates that although non-timber forest products are an important livelihood source, market integration and commercialization is not everywhere an appropriate or realistic strategy.     

Recombinant protein production in yeasts

Recombinant DNA (rDNA) technologies (genetic, protein, and metabolic engineering) allow the production of a wide range of peptides, proteins, and biochemicals from naturally nonproducing cells. These technologies, now approx 25 yr old, have become one of the most important technologies developed in the twentieth century. Pharmaceutical products and industrial enzymes were the first biotech products on the world market made by means of rDNA. Despite important advances in rDNA applications in mammalian cells, yeasts still represent attractive hosts for the production of heterologous proteins. In this review we summarize advantages and limitations of the main and most promising yeast hosts.     

Genomics-enabled discovery of phosphonate natural products and their biosynthetic pathways

Phosphonate natural products have proven to be a rich source of useful pharmaceutical, agricultural, and biotechnology products, whereas study of their biosynthetic pathways has revealed numerous intriguing enzymes that catalyze unprecedented biochemistry. Here we review the history of phosphonate natural product discovery, highlighting technological advances that have played a key role in the recent advances in their discovery. Central to these developments has been the application of genomics, which allowed discovery and development of a global phosphonate metabolic framework to guide research efforts. This framework suggests that the future of phosphonate natural products remains bright, with many new compounds and pathways yet to be discovered.     

On the Attractiveness of Product Recovery: The Forces that Shape Reverse Markets

Product recovery is a major contributor for implementing sustainable business practices. Within such operations, which are either driven by legislation or economic rationales, practitioners face strategic issues concerning reverse market entry and positioning. Although the complexity of acting on reverse markets is widely acknowledged, a comprehensive framework to facilitate decision making in this area is lacking. In an attempt to fill that gap, we develop a model that supports original equipment manufacturers’ (OEMs’) assessment of the attractiveness of reverse markets. We identify, from a comprehensive literature analysis, in‐depth interviews, and engagement with a dozen companies from different countries, factors that influence key characteristics of reverse markets, and consolidate this lengthy list into a comprehensive model intuitively applicable to business practice. The model combines five forces that drive reverse markets: access to recoverable products; threat of independent recovery companies’ (IRCs’) market entry; rivalry for recoverable products; adverse effects on core business; and remarketing opportunities. We propose for each a set of attributes that influences its power and direction. To demonstrate the efficacy of the model, we apply it in two industry settings: recovery of white goods in the United Kingdom and paper recycling in Germany. The present research enables OEMs to understand the structure and forces that drive reverse markets, identify levers to influence those markets, anticipate market developments, and formulate resilient strategies for product recovery.     

Antimicrobial enzymes: An emerging strategy to fight microbes and microbial biofilms

With the increasing prevalence of antibiotic resistance, antimicrobial enzymes aimed at the disruption of bacterial cellular machinery and biofilm formation are under intense investigation. Several enzyme-based products have already been commercialized for application in the healthcare, food and biomedical industries. Successful removal of complex biofilms requires the use of multi-enzyme formulations that contain enzymes capable of degrading microbial DNA, polysaccharides, proteins and quorum-sensing molecules. The inclusion of anti-quorum sensing enzymes prevents biofilm reformation. The development of effective complex enzyme formulations is urgently needed to deal with the problems associated with biofilm formation in manufacturing, environmental protection and healthcare settings. Nevertheless, advances in synthetic biology, enzyme engineering and whole DNA-Sequencing technologies show great potential to facilitate the development of more effective antimicrobial and anti-biofilm enzymes.     

Estimating the number of whales entering trade using DNA profiling and capture-recapture analysis of market products

Surveys of commercial markets combined with molecular taxonomy (i.e. molecular monitoring) provide a means to detect products from illegal, unregulated and/or unreported (IUU) exploitation, including the sale of fisheries bycatch and wild meat (bushmeat). Capture-recapture analyses of market products using DNA profiling have the potential to estimate the total number of individuals entering the market. However, these analyses are not directly analogous to those of living individuals because a 'market individual' does not die suddenly but, instead, remains available for a time in decreasing quantities, rather like the exponential decay of a radioactive isotope. Here we use mitochondrial DNA (mtDNA) sequences and microsatellite genotypes to individually identify products from North Pacific minke whales (Balaenoptera acutorostrata ssp.) purchased in 12 surveys of markets in the Republic of (South) Korea from 1999 to 2003. By applying a novel capture-recapture model with a decay rate parameter to the 205 unique DNA profiles found among 289 products, we estimated that the total number of whales entering trade across the five-year survey period was 827 (SE, 164; CV, 0.20) and that the average 'half-life' of products from an individual whale on the market was 1.82 months (SE, 0.24; CV, 0.13). Our estimate of whales in trade (reflecting the true numbers killed) was significantly greater than the officially reported bycatch of 458 whales for this period. This unregulated exploitation has serious implications for the survival of this genetically distinct coastal population. Although our capture-recapture model was developed for specific application to the Korean whale-meat markets, the exponential decay function could be modified to improve the estimates of trade in other wildmeat or fisheries markets or abundance of living populations by noninvasive genotyping.     

Management of product variety in cellular manufacturing systems

In today’s markets, non-uniform, customized products complicate the manufacturing processes significantly. In this paper, we propose a cellular manufacturing system design model to manage product variety by integrating with the technology selection decision. The proposed model determines the product families and machine groups while deciding the technology of each cell individually. Hedging against changing market dynamics leads us to the use of flexible machining systems and dedicated manufacturing systems at the same facility. In order to integrate the market characteristics in our model, we proposed a new cost function. Further, we modified a well known similarity measure in order to handle the operational capability of the available technology. In the paper, our hybrid technology approach is presented via a multi-objective mathematical model. A filtered-beam based local search heuristic is proposed to solve the problem efficiently. We compare the proposed approach with a dedicated technology model and showed that the improvement with the proposed hybrid technology approach is greater than 100% in unstable markets requiring high product varieties, regardless of the volumes of the products.     

Technological progress and challenges towards cGMP manufacturing of human pluripotent stem cells based therapeutic products for allogeneic and autologous cell therapies

Recent technological advances in the generation, characterization, and bioprocessing of human pluripotent stem cells (hPSCs) have created new hope for their use as a source for production of cell-based therapeutic products. To date, a few clinical trials that have used therapeutic cells derived from hESCs have been approved by the Food and Drug Administration (FDA), but numerous new hPSC-based cell therapy products are under various stages of development in cell therapy-specialized companies and their future market is estimated to be very promising. However, the multitude of critical challenges regarding different aspects of hPSC-based therapeutic product manufacturing and their therapies have made progress for the introduction of new products and clinical applications very slow. These challenges include scientific, technological, clinical, policy, and financial aspects. The technological aspects of manufacturing hPSC-based therapeutic products for allogeneic and autologous cell therapies according to good manufacturing practice (cGMP) quality requirements is one of the most important challenging and emerging topics in the development of new hPSCs for clinical use. In this review, we describe main critical challenges and highlight a series of technological advances in all aspects of hPSC-based therapeutic product manufacturing including clinical grade cell line development, large-scale banking, upstream processing, downstream processing, and quality assessment of final cell therapeutic products that have brought hPSCs closer to clinical application and commercial cGMP manufacturing.     

The growth of Korean immigrant entrepreneurship in Chicago

The growth of Korean immigrant entrepreneurship in Chicago is a product of three interacting factors: employment opportunities in the general labour market, resource mobilization, and business opportunity structures. Because of their language barrier and less transferable education and occupational skills in the American labour market, many Korean immigrants could not find white‐collar occupations for which they had been trained. Disadvantaged, but still strongly motivated for upward economic mobility in the United States, many of them became self‐employed business owners. Korean immigrants’ middle‐class backgrounds and their stable family structures and strong family ties helped them to realize their goal of business ownership. In addition, social networks based on kinship, friendship, church membership, and school ties provided prospective business owners with financial assistance, training, business advice, and information about business opportunities. The first business opportunities for Korean immigrants of Chicago opened in Korean ethnic markets and non‐ethnic minority markets almost simultaneously in the early 1970s. While the demand of Koreans for their cultural products created an economic niche for Korean‐oriented businesses, the export‐import trade linkage between South Korea and the United States has paved the way for the entrance of Korean businesses into minority areas. Because of different economic niches, the two types of Korean businesses developed independently. The interethnic succession of residence, which had occurred in the late 1960s and early 1970s also produced vacated business opportunities in Koreatown and black neighbourhoods, enabling Korean immigrants to enter these areas without great resistance from local businesses. After Korean immigrants had accumulated capital and experience in Korean ethnic markets and minority markets, they advanced into more capital‐intensive businesses like garment manufacturing. Korean immigrant professionals began to enter the Korean ethnic economy in the early 1980s when the foundation of the Korean ethnic economy was already established.     

Recent advances in the structural biology of modular polyketide synthases and nonribosomal peptide synthetases

Polyketides and nonribosomal peptides are an important class of natural products with useful bioactivities. These compounds are similarly biosynthesized using enzymes with modular structures despite having different physicochemical properties. These enzymes are attractive targets for bioengineering to produce “unnatural” natural products owing to their modular structures. Therefore, their structures have been studied for a long time; however, the main focus was on truncated-single domains. Surprisingly, there is an increasing number of the structures of whole modules reported, most of which have been enabled through the recent advances in cryogenic electron microscopy technology. In this review, we have summarized the recent advances in the structural elucidation of whole modules.