Efficiency and productivity of publicly-traded bio-pharmaceutical companies in Taiwan
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Abstract:
The biopharmaceutical industry has been rapidly growing these last few decades due to the breakthroughs in molecular biology since the 1970s. The Taiwan government initiated a program for developing the biotech industry as early as the 1980s. However, Taiwan's biopharmaceutical companies have failed to deliver any new drugs to the market in the last 30 years. Therefore, the managerial efficiency of these biopharmaceutical companies in Taiwan needs further examination. Traditional managerial efficiency measurements are either output-oriented or input-oriented, respectively. In this study we apply the directional distance function to estimate the relative managerial efficiency of eleven publicly-traded biopharmaceutical firms during the period 2012-2014. We also measure their productivity by means of the Malmquist-Luenberger index. Our results show that, during 2013-2014, the mean productivity of these companies declined, which can be possibly explained by the significant reduction in mean gross sales due to the occurrence of a serious food safety crisis in 2014. Taiwan's pharmaceutical firms have to pay more attention to their quality control over ingredients that are being used in food and drug production.Keywords:
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Glycosylation plays an important role in ensuring the proper structure and function of most biotherapeutic proteins. Even small changes in glycan composition, structure, or location can have a drastic impact on drug safety and efficacy. Recently, glycosylation has become the subject of increased focus as biopharmaceutical companies rush to create not only biosimilars, but also biobetters based on existing biotherapeutic proteins. Against this backdrop of ongoing biopharmaceutical innovation, updated methods for accurate and detailed analysis of protein glycosylation are critical for biopharmaceutical companies and government regulatory agencies alike. This review summarizes current methods of characterizing biopharmaceutical glycosylation, including compositional mass profiling, isomer-specific profiling and structural elucidation by MS and hyphenated techniques.
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Biopharmaceutical
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Membrane permeability
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The pulmonary dosing route has been advocated as an attractive alternative to injection and oral administration for the systemic delivery of therapeutic peptides and proteins. The lung possesses many favorable physiological characteristics for systemic absorption of inhaled peptides/proteins, so inhalable formulation systems of these drugs have generated considerable interest as a valid and non-invasive dosing approach. A major obstacle to the widespread use of inhalation therapies for many peptides/proteins is the limited bioavailability and thereby insufficient therapeutic outcomes because of biopharmaceutical challenges such as rapid pulmonary clearance, limited pulmonary deposition, delayed dissolution in lung environment, poor membrane permeability, and low metabolic stability. A better understanding of the biopharmaceutical properties of inhaled peptides/proteins would be indispensable to overcome these drawbacks with the aid of strategic drug delivery systems and chemical synthesis of new derivatives based on structure-activity relationship information, possibly leading to improved therapeutic potential of pharmaceutical products. The present paper reviews biopharmaceutical properties of inhaled peptides/proteins, with a focus on the pharmacokinetic fate of inhaled peptides/proteins and critical determinants of therapeutic potential. The emphasis in this mini-review will also be on viable formulation approaches for breakthroughs beyond the biopharmaceutical limitations of inhalation therapy with peptides/proteins. Keywords: Peptide, pharmacokinetics, pharmacodynamics, protein, pulmonary delivery.
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Biopharmaceutical
Biopharmaceutics
Drug Development
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Objective To review the impacts of biopharmaceutical characteristics on oral drug absorption.Methods Based on our previous work and related published papers,the effects of biopharmaceutical characteristics of drugs on their absorption were discussed.Results The solubility,stability in gastrointestinal tract,membrane permeability and presystemic metabolism of drugs were the major factors on oral drug absorption.Conclusions Biopharmaceutical characteristics of drugs have vital influences on oral drug absorption.In view of drug molecular structure and formulation designs,rational use of clinical drugs and oral drug-delivery systems designs,the biopharmaceutical properties of the drug should be regarded as an indispensable component.
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Modern biotechnology has resulted in a resurgence of interest in the production of new therapeutic agents using botanical sources. With nearly 500 biotechnology products approved or in development globally, and with production capacity limited, the need for efficient means of therapeutic protein production is apparent. Through genetic engineering, plants can now be used to produce pharmacologically active proteins, including mammalian antibodies, blood product substitutes, vaccines, hormones, cytokines, and a variety of other therapeutic agents. Efficient biopharmaceutical production in plants involves the proper selection of host plant and gene expression system, including a decision as to whether a food crop or a non-food crop is more appropriate. Product safety issues relevant to patients, pharmaceutical workers, and the general public must be addressed, and proper regulation and regulatory oversight must be in place prior to commercial plant-based biopharmaceutical production. Plant production of pharmaceuticals holds great potential, and may become an important production system for a variety of new biopharmaceutical products.
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Ideally, formulation development of biopharmaceutical protein therapeutics will provide a final dosage form that offers sufficient ex vivo stability during processing, handling, and long-term storage and also provide adequate in vivo stability in terms of bioavailability that meets the pharmacokinetics/pharmacodynamics (PK/PD) therapeutic requirements. This chapter focuses on ex vivo stability of protein therapeutics and is targeted for the novice researcher who struggles with the inherent instabilities of biological molecules. More important, this chapter provides the inexperienced formulators with fundamental understanding and the basic tools for formulation development of biopharmaceutical proteins.
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Ex vivo
Protein Stability
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