Pharmaceutical Industry Research Articles

Genetic Engineering Pharmaceutical Technology: A Brief Review

Genetic engineering has emerged as a transformative technology in the pharmaceutical industry, offering unprecedented control over the manipulation of genetic material. This technology enables the precise editing, combining, and expression of target genes in various organisms, leading to the production of specific proteins, enzymes, and biologics essential for therapeutic applications. This review provides an overview of the basic principles and strategies of gene therapy, the development of genetic engineering pharmaceuticals, and their applications in producing physiologically active substances, antibodies, and vaccines. The review also highlights the significant advancements in the field, and explores the future potential of genetic engineering in advancing medical science and improving human health.

Antioxidant Capacity and Cardiovascular Benefits of Fruits and Vegetables: A Proposal for Comparative Scales

Fruits and vegetables are sources of natural nutraceuticals. They contain a variety of bioactive compounds such as vitamins, minerals, dietary fibers and other phytochemicals that contribute to their health-promoting properties and disease prevention. A wide variety of fruits and vegetables should be eaten to ensure that an individual’s diet includes a combination of phytonutraceuticals and to obtain all their health benefits. This study aimed to compare the antioxidant potential and cardiovascular benefits within a restricted sample of ten fruits and ten vegetables, previously reported as largely consumed in Portugal. With data available from the literature, antioxidant potential scales were established. Additionally, a set of seven criteria, including high antioxidant capacity (FRAP values above 1), presence of n-3 fatty acids, saturated fat, cholesterol, trans fatty acids, fiber and sodium was used to create comparative scales of their potential cardiovascular benefits. The main results showed that the fruits that simultaneously exhibited the highest antioxidant potential values and the highest cardiovascular potential benefit were lemon, grapes, and melon; among vegetables, the top rankings were found to be tomato and onion. These products have been recognized as interesting sources of natural nutraceuticals for the food and pharmaceutical industries. In the future, similar approaches are desirable to translate complex scientific data into practical, simple and user-friendly information for food literacy initiatives, including nutrition education materials, about the relative level of the potential cardiovascular benefits of a wide diversity of food products.

Enhancing the oil extraction process and exploring phytochemical composition and bioactivities of bitter melon seeds (Momordica charantia L.)

This study was conducted to determine the phytochemical composition of bitter melon seeds (Momordica charantia L.) grown in Long An province (Vietnam), to investigate optimal conditions for lipid extraction, and to evaluate the extracted lipid’s quality. The seeds had a moisture content of 5.27%, total ash of 1.85%, total flavonoid content of 91.10 mg/100 g, and total polyphenol content of 478.95 mg/100 g. The seeds were also free of highly toxic metals such as lead and cadmium. Using the Soxhlet method, optimal lipid extraction was achieved with a material-to-solvent ratio of 1:80 (w/v) over 4 hours, resulting in a lipid extraction efficiency of 13.74%. The acid, saponification, ester, and peroxide values were 1.01 mg KOH/g, 355.60 mg KOH/g, 354.59 mg KOH/g, and 3.82 meq O2/kg, respectively, in compliance with the quality requirements of Vietnam and Codex standards. The extracted lipids had antioxidant activity at an IC50 value of 119 mg/mL and inhibited the growth of two microbial strains Staphylococcus aureus and Bacillus subtilis subsp. spizizenii. These findings suggest that bitter melon oil has potential applications in the food, pharmaceutical, and cosmetic industries.

Recent Advances in the Synthesis of Sulfonamides Intermediates

AbstractSulfonamides are one of the most important synthons in drug synthesis, which can increase the water solubility of drugs and regulate their metabolism in vivo. According to statistics, nearly 30% of sulfur-containing drugs on the market contain sulfonamide groups, including omeprazole, hydrochlorothiazide, and other best-selling drugs. Synthesis of sulfonamide is therefore a very important part of new drug development and active pharmaceutical ingredient manufacturing. In this review, we will focus on the recent 5-year advances in the field of synthetic research and structural modification of sulfonamide-containing drugs and their intermediates. The synthesis strategies, including S−N construction, C−N cross-coupling, N−H functionalization, and C−H sulfonamidation, are discussed, hoping to provide new ideas for the researchers to prepare sulfonamides in a green and efficient way.

An Overview of Continuing Medical Education/Continuing Professional Development Systems in the Middle East and North Africa: A Mixed Methods Assessment

ABSTRACT The aims of this assessment were to describe the requirements for physicians to engage in CME/CPD; explore perceptions of in-country SMEs of their CME/CPD systems; describe perceptions of in-country physicians about interprofessional continuing education (IPCE) and independent CME/CPD; and provide recommendations that may be adopted to improve quality and effectiveness. An assessment of CME/CPD systems in the Middle East and North Africa was conducted using a mixed-methods approach that included 1:1 interviews with in-country SMEs and an electronic survey capturing qualitative and quantitative data from practicing in-country physicians. The results of this assessment were strongly influenced by Egypt and Israel in the Middle East, and Algeria and Morocco in North Africa. The CME/CPD systems demonstrate wide variation from absent/immature systems to robust/mature systems. Strategies to improve the quality of the CME/CPD systems range from implementing basic standards in North Africa to evaluating the impact of CME/CPD in practice in the Middle East. The maturity of CME/CPD systems seems to affect physician awareness, independence from the influence of pharmaceutical companies over education, and IPCE, with more mature systems having a positive relationship to awareness, independence and engagement in IPCE. Maturity of CME/CPD systems is less tied to physician perceptions of value of CME/CPD, hours of participation, perceptions of what is missing from current systems, and preferred formats of education.

An Analysis of The Relationship Between ESG Performance and Corporate Value Across Industries

High-quality economic development requires sustainable green development of enterprises. This paper analyses the impact and path of Environmental, Social and Corporate Governance (ESG) practices on enterprise value under the pharmaceutical, coal, and information technology industries. It is found that: (1) ESG performance in the above three industries has a positive impact on enterprise value. (2) Due to the characteristics of the industries themselves, the paths of ESG on corporate value are different: information technology companies focus more on green technological innovation, the coal industry focuses more on internal stakeholder-centered ESG enhancement, and the path of ESG practices in the pharmaceutical industry is more diversified than that in the pharmaceutical industry, which is conducive to the realization of corporate value through a combination of the three major aspects of environmental, social, and corporate governance. This paper points out the shortcomings of the existing ESG practices through the universal experience of the three industries, which is of great significance for the major industries in the development and implementation of ESG activities.

A Study on Financial Risk Early Warning in Pharmaceutical Companies: The Case of Ruikang Pharmaceutical

This paper analyzes the financial data of Ruikang Pharmaceutical from 2021 to 2023 through the Z-score model. This calculation method makes the multivariate linear discriminant analysis method proposed by the American scholar Edward Eltman. This approach evaluates the financial health of a firm by combining multiple financial indicators in a weighted manner to arrive at a composite indicator, Z-score. Systematically analyze the operation status and bankruptcy of the enterprise, so as to evaluate the potential risks that the company may face in financial aspects, and warn the possible problems in advance, so as to help the enterprise take corresponding measures to avoid risks, improve the competitiveness and sustainable development of the enterprise, and ensure the financial health and stable development of the company. It can improve the ability of pharmaceutical companies to provide high-level and high-quality services, provide reasonable fund management programs for enterprises themselves, and meet the market demand. Through the calculation and analysis results, it can be seen that there are certain financial risks in Ruikang Pharmaceutical, and Ruikang Pharmaceutical has been on the edge of bankruptcy for three years. Finally, this paper puts forward the corresponding solutions and countermeasures to improve the vitality of the company and make it develop for the better.

Impact of Strategic Alliances on Competitive Advantage: A Field Study on Pharmaceutical Companies in the Republic of Yemen

Impact of Strategic Alliances on Competitive Advantage: A Field Study on Pharmaceutical Companies in the Republic of Yemen

Native and cationic cellulose nanofibril films enriched with avocado seed compounds as a green alternative for potential wound care applications

Cellulose nanofibrils (CNF) show great potential for skin wound care and healing due to their biocompatibility, non-cytotoxicity, and high swelling with good mechanical stability. In the presented study, for the first time native and cationized cellulose nanofibrils were used in combination with avocado seeds extracts obtained with different extraction methods (ASE), as an alternative to a well-known antibiotic, Clindamycin, to produce films with high and long-lasting antimicrobial efficacy. The swelling capacity of prepared films and extracts/antibiotic release kinetics were studied at different pH values to evaluate pH response behavior.All developed films exhibited high bacteriostatic and bactericidal activity against Gram-negative Escherichia coli and G-positive Staphylococcus aureus, resulting in up to 100 % bacterial reduction with the log reduction factor up to 5.64 or 6.50, at 14.2 mg of avocado seed extract or clindamycin integrated in the 1 cm2 of CNF film. The high swelling capacity (up to 65.67 %) and stability of avocado seed extracts-enriched CNF films provide a suitable moisture environment and a sustainable release (up to 40.98 % in 48 h) of bioactive compounds. The prepared antibacterial films' chemical and morphological characteristics and pH-responsive behavior proved the potential applications in the cosmetics, biomedicine, and pharmaceutical industry.

A substrate-induced dual utilization cascade reaction of N-alkyl anilines: highly site-selective sustainable synthesis of chromeno[4,3-b]quinolin-6-ones.

We describe a novel substrate-induced cascade reaction of N-alkyl anilines via C(sp3)-N bond cleavage and reorganization into chromeno[4,3-b]quinolin-6-ones. N-alkyl anilines are not only used as a carbon source, but also the waste group was trapped by 4-hydroxy coumarin. The calculation of green metrics shows that our protocol is more efficient and green with lower emission than before. Additionally, a gram-scale reaction and one-pot synthesis of bioactive molecules further demonstrate the potential application of our protocol in the pharmaceutical industry.

Engineering a two-enzyme system in Mycolicibacterium neoaurum for efficient biotransformation of phytosterols to dihydrotestosterone.

Dihydrotestosterone (DHT) is a valuable steroid drug with widespread clinical applications, but traditional chemical synthesis is environmentally harmful and requires complex reaction conditions. This study introduces a one-step microbial transformation method for the production of DHT from inexpensive phytosterols (PS) using engineered Mycolicibacterium neoaurum (MNR). The heterologous expression of 5α-reductase (5α-R) and 17β-hydroxysteroid dehydrogenase (17β-HSD) in MNR enabled the efficient conversion of PS to DHT. To further enhance 5α-R activity, semi-rational mutagenesis was employed, which significantly increasing DHT production. Molecular dynamics simulations provided insights into the underlying mechanisms driving this enhancement. Additionally, the incorporation of a PntAB-based NADPH regeneration system further improved DHT yield. Process optimization resulted in a maximum DHT concentration of 1.123 g·L-1, representing the first gram-scale microbial production of DHT. Compared to traditional chemical synthesis, this biotransformation method offers milder reaction conditions, reduced environmental impact, and eliminates the need for toxic catalysts. This work demonstrates a sustainable and efficient microbial method for DHT production, with significant industrial potential for the greener manufacturing of steroid hormone drugs.

Efficient Positioning of QTL and Secondary Limit Thresholds in a Clinical Trial Risk-Based Monitoring.

In the high-stakes world of clinical trials, where a company's multimillion-dollar drug development investment is at risk, the increasing complexity of these trials only compounds the challenges. Therefore, the development of a robust risk mitigation strategy, as a crucial component of comprehensive risk planning, is not just important but essential for effective drug development, particularly in the RBQM (Risk-Based Quality Management) ecosystem and its component-RBM (Risk-Based Monitoring). This emphasis on the urgency and significance of risk mitigation strategy can help the audience understand the gravity of the topic. The paper introduces a novel modeling framework for deriving an efficient risk mitigation strategy at the planning stage of a clinical trial and establishing operational rules (thresholds) under the assumption that contingency resources are limited. The problem is solved in two steps: (1) Deriving a contingency budget and its efficient allocation across risks to be mitigated and (2) Deriving operational rules to be aligned with risk assessment and contingency resources. This approach is based on combining optimization and simulation models. The optimization model aims to derive an efficient contingency budget and allocate limited mitigation resources across mitigated risks. The simulation model aims to efficiently position each risk's QTL/KRI (Quality Tolerance Limits/Key Risk Indicators at a clinical trial level) and Secondary Limit thresholds. A case study illustrates the proposed technique's practical application and effectiveness. This example demonstrates the framework's potential and instills confidence in its successful implementation, reassuring the audience of its practicality and usefulness. The paper is structured as follows. (1) Introduction; (2) Methodology; (3) Models-Risk Optimizer and Risk Simulator; (4) Case study; (5) Discussion and (6) Conclusion.

Highly Enantioselective Synthesis of 3,3-Diarylpropyl Amines and 4-Aryl Tetrahydroquinolines via Ir-Catalyzed Asymmetric Hydrogenation.

Chiral nitrogen-containing compounds are crucial for the chemical, pharmaceutical, and agrochemical industries. Nevertheless, the synthesis of certain valuable scaffolds remains underdeveloped due to the vast chemical space available. In this work, we present a diastereoselective methodology for synthesizing 3,3-diarylallyl phthalimides, which, following iridium-catalyzed asymmetric hydrogenation using Ir-UbaPHOX, yield 3,3-diarylpropyl amines with high enantioselectivity (98-99% ee). The importance of alkene purity to achieve high enantioselectivity is discussed. The synthetic utility of the chiral propylamines obtained is demonstrated through the preparation of medicinally useful bioactive compounds like the drugs tolterodine and tolpropamine and 4-aryl tetrahydroquinolines. This strategy enables the synthesis of these compounds with the highest enantioselectivity reported to date.

A Review on Evolution and Challenges of Pharmaceutical Patent Protection in India

The Indian pharmaceutical patent system has undergone substantial changes through amendments to the Patents Act of 1970, particularly with the 2005 TRIPS compliance modifications. The system's cornerstone, Section 3(d), prevents patent extensions through minor molecular modifications unless significant therapeutic benefits are demonstrated. This provision gained global attention during the Novartis Glivec patent dispute, establishing India's firm stance on patentability criteria. India maintains specific safeguards within its patent framework, including a dual-opposition system and compulsory licensing provisions, which have proven crucial in maintaining medicine affordability. The Bayer-Natco case involving the cancer drug Nexavar highlighted the practical application of compulsory licensing to address public health needs. Patent office modernization efforts have targeted prolonged examination timelines and application backlogs, though administrative challenges persist. While multinational pharmaceutical companies express concerns about innovation protection, India's approach has enabled a robust generic drug industry that supplies affordable medicines globally. The patent system continues to evolve, balancing domestic healthcare requirements with international patent obligations. Recent technological upgrades in patent offices and refined examination guidelines demonstrate India's commitment to efficient patent administration while maintaining its public health priorities.

Accelerating virtual patient generation with a Bayesian optimization and machine learning surrogate model.

The pharmaceutical industry has increasingly adopted model-informed drug discovery and development (MID3) to enhance productivity in drug discovery and development. Quantitative systems pharmacology (QSP), which integrates drug action mechanisms and disease complexities to predict clinical endpoints and biomarkers is central to MID3. QSP modeling has proven successful in metabolic and cardiovascular diseases and has expanded into oncology, immunotherapy, and infectious diseases. Despite its benefits, QSP model validation through clinical trial simulations using virtual patients (VPs) is challenging because of parameter variability and high computational costs. To address these challenges, this study proposes a hybrid method that combines Bayesian optimization with machine learning for efficient parameter screening. Our approach achieved an acceptance rate of 27.5% in QSP simulations, which is in sharp contrast with the 2.5% rate of conventional random search methods, indicating more than 10-fold improvement in efficiency. By facilitating faster and more diverse VPs generation, this method promises to advance clinical trial simulations and accelerate drug development in pharmaceutical research.

Comparison of C-type Nanoantibody Produced in Different Expression Systems Implying Potential Clinical Applications.

In the pharmaceutical industry, the Chinese hamster ovary cell, a type of mammalian cell, is extensively employed for the production of conventional full-length monoclonal antibodies. Nanobody is one of the most attractive directions for the development of next-generation antibody drugs. However, a suitable expression system for its manufacture has not yet been comprehensively evaluated. Previously, we proposed that the immunoglobulin constant CH2 domain could be a promising scaffold for developing C-type nanoantibodies (C-Nabs) as candidate therapeutics. Here, we used an antiviral C-Nab, which we identified previously (under review), as a model for investigation. We expressed C-Nabs without a tag in different systems, including a bacterium (C-Nabbac), yeast (C-Nabyeast), and mammalian cell (C-Nabmam). After purification, the binding and neutralizing activities of C-Nabs from different expression systems are similar. Their secondary structures are rich in β-strand. The melting temperatures of C-Nabbac (71.5 °C) and C-Nabmam (70.2 °C) are similar, which are slightly higher than that of C-Nabyeast (65.6 °C), while C-Nabyeast and C-Nabmam are more resistant to urea-induced unfolding than C-Nabbac. C-Nabyeast and C-Nabmam demonstrate higher resistance to aggregation compared to C-Nabbac. C-Nabyeast exhibits greater resistance to enzyme digestion compared to C-Nabbac and C-Nabmam. Notably, when administered via intraperitoneal injection in mice, C-Nabyeast shows superior pharmacokinetics. Overall, after comparing C-Nab proteins from various expression systems, we determined that yeast is the most suitable host for producing C-Nabs. This finding is beneficial for the production of nanobodies as potential drug candidates.

Mangifera indica L. leaf assisted biosynthesis and characterization of silver nanoparticles and their antifungal activity against plant pathogen Aspergillus niger Tiegh.

The biosynthesis of silver nanoparticles is an emerging field in nanotechnology. There are several different methods to prepare silver nanoparticles depending upon their uses such as in the pharmaceutical and textile industries, and the field of medicine. One of the most important applications of silver nanoparticles is their antifungal activity against different plant pathogenic fungi. In this study, a cost-effective and environment-friendly method was used to synthesize silver nanoparticles using leaf extract of different varieties of Mangifera indica L. The varieties used in this study were Fajri, Malta, Sinduri, Sufaid Chaunsa, and Langra. The aqueous extract of the leaves of mango acted as reducing and stabilizing agents for the silver nanoparticles. The formation of silver nanoparticles was confirmed by the UV-Vis spectroscopy in which a surface plasmon resonance peak within the range of 448-454 nm was observed. FTIR analysis was also performed which showed the bands between 3738 cm-1 to 432 cm-1 which confirmed the presence of different chemical groups. Silver nanoparticles were further characterized by the scanning electron microscopy which revealed the sizes of the nanoparticles within the range of 12-235 nm. After characterization, the antifungal activity of biosynthesized silver nanoparticles was evaluated. From the results, it was concluded that all the varieties showed a greater inhibitory effect at the concentration of 100 mg/L, but it was observed that silver nanoparticles prepared by the leaf extract of cv. Fajri exhibited a greater inhibitory effect against Aspergillus niger having a percent inhibition of 79.8%.

Workplace genetic testing: which employees are likely to participate, what are their concerns with employer sponsorship, and which design features could reduce barriers and increase participation?

Voluntary genetic testing (GT) leverages low-cost DNA sequencing and other testing methods to provide genetic risk screening for healthy individuals. Given the potential to prevent disease and promote health, some employers now offer GT as an employee benefit (workplace GT, or wGT), but participation remains low. To investigate facilitators and barriers to wGT participation, we conducted one of the first representative surveys of working U.S. adults on this topic (n = 958). We assessed factors that could influence participation, including: sponsoring entity (health provider or employer), program design, and individual demographics. Two-thirds (68%) of respondents indicated willingness to participate in some type of GT, but only half (49%) expressed willingness to participate through their employer. Women were 60% more willing to participate than men, and individuals with previous genetic testing experience were 143% more willing to participate than those without such experience. Across all demographic groups, certain GT program design features tended to increase or decrease willingness to participate. The ability to have one's data deleted from the GT database increased willingness most often (true for 67% of respondents), while selling data to pharmaceutical companies decreased willingness most often (true for 63% of respondents).

The reference price regulation in the AMNOG market - a view from practice

The Pharmaceutical Market Reorganisation Act (AMNOG) was introduced by the legislator in 2010 as a supplement to the reference price system, which had already been in place for a long time. The AMNOG instruments were intended to regulate prices in the 'non-fixed price market'. The AMNOG obliges the National Association of Statutory Health Insurance Funds and the pharmaceutical company, as the explanatory memorandum to the law briefly and succinctly stated at the time, 'to agree a reimbursement amount for non-fixed-price drugs with new active ingredients with effect for all health insurance funds' (Deutscher Bundestag 2010: 31). In reality, however, the exact application and delimitation of both instruments were unclear. The categorisation of drugs without proven additional benefit into the reference price system was considered the standard case in the initial concept: 'Without additional benefit - transfer to the reference price system' was the chapter heading in the explanatory brochure of the Federal Ministry of Health on the AMNOG (BMG 2010: 16). In these cases, the reimbursement amount negotiation should only be necessary on an interim basis. On closer inspection, however, there was a lack of concrete guidelines as to which instrument should be used when and how the different regulatory logics of the two systems should be harmonised. De facto, the self-administration had a great deal of room for manoeuvre here. This article analyses how the reference price regulation has been applied in practice in the AMNOG market since 2011. After a brief explanation of the legal framework (1), different case constellations are presented and the procedural practices of the self-administration are analysed in each case (2). The analysis is based on all benefit assessment procedures published by the Federal Joint Committee (G-BA) up to and including 15 July 2024 in which the reference price regulation has become relevant. These 42 procedures for 27 medicinal products were classified and compared. The review is followed by a discussion of the challenges and problems arising from procedural practice (3). Overall, the present study shows that reference price regulations in the AMNOG market have so far tended to be a 'procedural sidetrack' in practice (4).

Evaluation of Polyphenols, Antioxidant Activity, and Mineral Content in Honey Produced by <i>Apis mellifera</i> L. According to Floral Origin

Background/Objectives: Honey is in high demand because of its nutritional value, therapeutic properties, and sensory characteristics. Honey varieties were evaluated according to their floral origin and physicochemical composition, and total polyphenols, antioxidants, and minerals were analyzed for conformity and preference. Methods: Seven honey samples were analyzed for physicochemical composition using the Official Methods of Analysis method, total polyphenols using the Folin–Ciocalteu method, flavonoids using the ferric trichloride method, antioxidant activity and inhibitory concentration using the 2,2-diphenyl-1-picrylhydrazyl (DPPH) method, and ferric reducing capacity using the ferric-reducing antioxidant power (FRAP) method. Inductively coupled plasma optical emission spectroscopy was used to determine the mineral composition of the honey varieties. Results: The physicochemical compositions of the honey samples did not show significant differences and complied with national regulations. Total phenolic compound content was 336.9–1064.9 μg EAG/g, whereas flavonoids were between 0–151.9 μg EQ/g, with eucalyptus honey having the highest concentration. The antioxidant capacity measured using DPPH and FRAP was 0.095–0.186 and 0.168–0.654 mM TEAC/g, respectively. Variability was observed in the calcium (161.55 mg/kg in eucalyptus), magnesium (35.20 mg/kg in eucalyptus), potassium (901.17 mg/kg in eucalyptus), and sodium (172.18 mg/kg in pecan aroma) levels. Heavy metals did not exhibit significant values. The correlation between total flavonoid content and antioxidant capacity was weak; a strong correlation was observed between total phenolic compounds and antioxidant activity. Conclusions: The antioxidant activity, bioactive compounds, and minerals in honey vary according to its floral origin, which could be helpful in the pharmaceutical industry and gastronomy.