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The concept of extractables and leachable has introduced a new era for identifying potential impurities in drug products. Pharmaceutical packaging materials encompass a variety of polymers due to their appealing properties for storing the drug product. However, numerous chemical species may leach into the drug product from these polymers, posing significant health hazards in the public domain. Identifying such leachable is crucial for assessing safety and addressing toxicological concerns. Acrylic acids are commonly used materials for adhering needles to the barrel in pre-filled syringes. In this study, we identified acrylic acid leachable impurities in ganirelix drug products available in the market using mass spectrometry as an analytical technique. These impurities leached into the drug product during storage conditions. Characterization of the impurities was carried out through data obtained from HRMS and MS/MS analysis, revealing them as polyacrylic acid-ganirelix adduct impurities. This study offers valuable insights into identifying leachable and susceptible sites, providing a foundation for potential modifications in similar classes of drug products, thereby enhancing their safety and efficacy. [ABSTRACT FROM AUTHOR]

Rationale: Disulfide bridges (DSB) play an important role in stabilizing threedimensional structures of biopharmaceuticals, single purified proteins, and various cyclic peptide drugs that contain disulfide in their structures. Incorrect cross-linking known as DSB scrambling results in misfolded structures that can be inactive, immunogenic, and susceptible to aggregation. Very few articles have been published on the experimental annotation of DSBs in proteins and cyclic peptide drugs. Accurate characterization of the disulfide bond is essential for understanding protein confirmation. Methods: Characterizing DSBs using mass spectrometry (MS) involves the chemical and enzymatic digestion of samples to obtain smaller peptide fragments, in both reduced and nonreduced forms. Subsequently, these samples are analyzed using MS to locate the DSB, either through interpretation or by employing various software tools. Results: The main challenge in DSB analysis methods using sample preparation is to obtain a sample solution in which nonnative DSBs are not formed due to high pH, temperature, and presence of free sulfhydryl groups. Formation of nonnative DSBs can lead to erroneous annotation of disulfide bond. Sample preparation techniques, fragmentation methods for DSB analysis, and contemporary approaches for DSB mapping using this fragmentation were discussed. Conclusions: This review presents the latest advancement in MS-based characterization; also a critical perspective is presented for further annotation of DSBs using MS, primarily for single purified proteins or peptides that are densely connected and rich in cysteine. Despite significant breakthroughs resulting from advancements in MS, the analysis of disulfide bonds is not straightforward; it necessitates expertise in sample preparation and interpretation. [ABSTRACT FROM AUTHOR]

Rationale: Enasidenib (EDB) is an orally active selective mutant isocitrate dehydrogenase‐2 enzyme inhibitor approved by the U.S. Food and Drug Administration to treat acute myeloid leukemia. It lacks a reported forced degradation study and a stability‐indicating assay method (SIAM). This study addresses this gap by establishing a degradation profile in accordance with the International Council for Harmonisation Q1A and Q1B (R2) guidelines and developing a validated SIAM for EDB. Methods: EDB was exposed to forced degradation under various conditions (hydrolytic, photolytic, oxidative, and thermal stress). Degradation samples were analyzed using high‐performance liquid chromatography on an Agilent ZORBAX Eclipse Plus C18 column with a mobile phase consisting of 0.1% formic acid in Milli‐Q water and acetonitrile at a flow rate of 1 mL/min and detection at 270 nm. Liquid chromatography‐quadrupole time‐of‐flight‐high‐resolution mass spectrometry (LC/Q‐TOF HRMS) was used for the identification and characterization of degradation products. Nitrosamine risk assessment was conducted using a modified nitrosation assay procedure (NAP) test due to the presence of a secondary amine group in the drug, which is liable to forming nitrosamine drug substance–related impurities (NDSRI). Results: The drug exhibited significant degradation under acidic, basic, photolytic, and oxidative conditions in the solution state. A total of nine degradation products (DP) were formed (DP‐I, DP‐III, and DP‐IV: acidic conditions; DP‐I and DP‐III: basic conditions; DP‐II, DP‐V, DP‐VI, and DP‐VII: oxidative stress; and DP‐VII, DP‐VIII, and DP‐IX: photolytic conditions), which were separated and identified using reversed‐phase high‐performance liquid chromatography and characterized using liquid chromatography–tandem mass spectrometry. The mechanism behind the formation of EDB degradation products has been discussed, and this study was the first to develop a degradation pathway for EDB. In addition, the possibilities of NDSRI formation for EDB were studied using a modified NAP test, which can contribute to the risk assessment of the drug. Conclusions: Forced degradation studies were conducted by establishing a SIAM for EDB. All the degradation products were characterized by mass spectral data obtained using LC/Q‐TOF‐HRMS. [ABSTRACT FROM AUTHOR]

Nanotechnologies exploit a material's 10−9 nanometric scale properties, which differ in physicochemical and biological properties. Various biological mechanisms of the human body activate at the nanometric scale. Nanoparticles (NPs) can traverse via natural obstacles to find new delivery targets and engage with DNA or small proteins at various levels, making NPs useful in pharmaceutical, biomaterial, and diagnostic applications. Producing nanomaterials for specific uses requires controlling synthetic NP's size distribution, shape, surface chemistry, dispersion, aggregation stability, elemental, and nanocrystalline content. NPs are becoming increasingly relevant in fundamental research and applications. The size measurement of NPs still poses a challenge for many researchers and pharmaceutical companies. NPs may frequently be assessed using several techniques, including dynamic light scattering, nanoparticle tracking analysis, tunable resistive pulse sensing, atomic force microscopy, and disc centrifugation, but there are advantages and disadvantages associated with each technique. As per regulatory requirements, the particle size of nanoparticles used in biomedical applications requires an orthogonal approach for characterizations. Therefore, a combinatorial characterization approach is needed to measure the sizes of nanoparticles in pharmaceutical formulations. This review provides a piece of detailed knowledge on recent advancements in analytical techniques with their sample preparations, data interpretations, operational principles, and critical strategies of each technique used for measuring nanoparticle size in various pharmaceutical formulations and vaccine research which will help researchers choose the best appropriate techniques for measuring NP's size. [ABSTRACT FROM AUTHOR]

[Display omitted] • Corn-derived nanocomplex was developed for dual drug loading capabilities. • A simple, accurate and precise method was developed for simultaneous estimation of 5-FU and silibinin in corn-nanocomplex. • The in vitro drug release study of prepared corn-derived nanocomplex was performed. • Mathematical modelling of drug release studies was investigated. In the current work, RP-HPLC method was developed and validated for simultaneous analysis of 5-Fluorouracil (5-FU) and silibinin from corn-derived protein polysaccharide nanocomplex. The method employs a mobile phase of water (A) and acetonitrile: methanol (60:40) (B) on a Waters C18 column (4.6 x 150 mm, 5 μm), with detection wavelengths set at 266 nm and 288 nm for 5-FU and silibinin, respectively. The runtime was 15 min at a flow rate of 0.7 mL/min. The analytical method validation adhered closely to ICH guidelines, exhibiting remarkable selectivity, specificity, linearity, and precision, all falling comfortably within acceptable thresholds. The analytical method was found to be linear from 1 to 150 µg/mL with R2 of 0.9998. Forced degradation studies were carried to assess the stability of 5-FU and silibinin within the nanocomplex across diverse conditions. Additionally, nanocomplexes loaded with 5-FU and silibinin were formulated and characterized, demonstrating a particle size of 209.83 ± 3.83 nm and a zeta potential of 57.93 ± 1.06 mV. The %entrapment efficiency for 5-FU and silibinin was found to be 88.73 ± 0.37 % and 97.00 ± 1.58 % with a %drug loading of 6.73 ± 0.92 % and 2.74 ± 0.61 % respectively. The % in vitro drug release was determined using developed and validated analytical methods. Further, various release kinetic models were applied to determine the release behavior from the nanocomplex system. To conclude, we ensured the eco-friendliness of the developed analytical method by assessing its greenness through Eco-scale, the green analytical procedure index (GAPI), and the Analytical GREEnness metric (AGREE). [ABSTRACT FROM AUTHOR]

The article discusses the legal aspects of biobanking and a right to privacy in India, and it mentions the globalization of science and technology, as well as India's regulation and governance of biomedical research. Emerging technologies are addressed, along with ethical conflicts involving research and development (R&D) and clinical trials. Millennium Development Goals (MDGs) are examined, along with the Indian Council for Medical Research and health research, and non-communicable diseases.

Drawing on the lessons from India and China in Bt cotton, this paper argues that emerging linkages between regulation, promoting innovation and access to innovation call for a new approach. Intellectual property rights and regulatory regimes may constrain diffusion and usage of technology. In the new approach, state’s intervention through appropriate policies for promoting innovation is important and Socio-Economic assessment of technologies should also play a role in policy formulation. The emerging concept of Responsible Research and Innovation (RRI) can be useful in framing the new approach. The paper points out that understanding of access to and availability of innovations can be linked with the RRI framework, and a coherent policy framework that promotes both access and responsible innovation can be developed. It also points out that this framework will facilitate development of socially relevant innovations and will also be useful in addressing controversies in development and use of innovations. [ABSTRACT FROM AUTHOR]

This article examines the emerging trends in India's role as a provider of development assistance to the other developing countries of the global South. Though India has diversified the regional focus and has multiplied the quantum of development assistance, there remain several challenges at various levels. The expectations from the development partners have gone up but is India prepared with the institutional frameworks that would be required to administer the desired scale of response? Is there enough preparedness to undertake impact assessment? This article attempts to address some of these issues. [ABSTRACT FROM AUTHOR]

Although Article 26 of the Cartagena Protocol enables countries to take into account socio-economic aspects in decision-making with respect to Living Modified Organisms (LMOs), translating that into practice has not been easy. Countries have followed different approaches; while some countries have chosen to use a comprehensive list of socio-economic impacts they want to assess, some countries have not given to this much importance. This article explains the need for taking socio-economic aspects into account and analyses the practices followed in this. It suggests a model that differentiates technology regulation from decision-making taking into account the socio-economic aspects. This model takes into account the socio-economic aspects in four stages of commercialisation and it is suggested as a suitable model for developing countries. [ABSTRACT FROM AUTHOR]

Over the years the methodologies for collecting data on science and technology (S&T) and developing indicators based on the analysis of the data collected have been useful to policy makers and the scientific community as the indicators help in developing evidence-based policies, assessing the impacts of investments in S&T and identifying the strengths and weaknesses in the innovation systems. However recently, there have been initiatives to develop better indicators, improve the methodologies and identify what is more relevant in terms of policy making. This article provides an overview of these debates and related developments in the Indian context, with a focus on access, equity and inclusion aspects of S&T policy and how to integrate them in S&T indicators. [ABSTRACT FROM AUTHOR]

The article discusses the trade and investment relations of India to Africa. It notes that the trade patterns of the two countries have developed in which India's deal with Africa had been doubled from 5.5 to 12.24 billion dollars in 2006-07. It states that India had introduced various initiatives such as the Pan African Network to give tele-medicine and tele-education benefits to Africa. It speculates that India will become a vital export destination for many African countries in the future.

The emergence of the sectoral systems of innovation (SSI) framework for analysing shifts in technological trajectory and economic growth has evoked a great deal of interest. Many researchers working on the National Systems of Innovation (NSI) concept have welcomed the approach and shown interest in the interplay between national and sectoral frameworks and related policy prescriptions. This paper attempts to analyse emerging and missing linkages between SSI and NSI in the biopharmaceutical sector in India. It does so in the light of major expansion in the Indian pharmaceutical industry and the new efforts to incorporate strategies targeting biotechnology innovation. The paper studies the policy regime facilitating this new era and discusses the future growth prospects of the Indian biopharmaceutical industry. [ABSTRACT FROM AUTHOR]

The study of industry associations occupies an uneasy ground in development economics. There is much empirical work that shows that industry associations fulfil important developmental roles in developing countries, often compensating for inadequacies in the business environment. Yet their status as institutions capable of generating growth is compromised because of the rent-seeking behaviour they embody. We study two different technology-based industries, namely software services and biotechnology, both of which formed industry associations to influence government policy and to aid the growth of their member firms, paying attention to their motivations for setting up, detailing the policies they sought to influence and their success as organisations. [ABSTRACT FROM AUTHOR]

China and India have emerged as highly dynamic economies in recent years. In the Asian region, their growth and economic expansion has generated its own complementarities. The article empirically shows that a surge in the exports of these two countries has significantly contributed to their overall economic growth. Towards this end, both the countries have relied on least developed countries (LDCs) and developing countries for their imports and on markets of industrialised economies for exports. The import dependence of India and China is mostly on the industrial intermediate sector, which is critical for their exports. Supply and technology constraints in LDCs and other countries may be addressed explicitly, and relevance of these two countries as suppliers of foreign direct investment (FDI) and technology is examined. India and China have made steady progress in frontier technologies, such as information and communication technology (ICT) and biotechnology, and they may provide easy access to these technologies to LDCs and other countries. [ABSTRACT FROM AUTHOR]

Several regulatory organizations encourage the quantitative analysis of potentially genotoxic impurities in finished pharmaceutical preparation. For the first time, a sensitive, accurate, and reliable reversed phase‐high‐performance liquid chromatography method was developed and validated for two antihypertensive drugs, three genotoxic impurities of Amlodipine namely methyl benzene sulfonate, ethyl benzene sulfonate, and ethyl‐p‐toluene sulfonate, as well as N‐methyl O‐phenylenediamine dihydrochloride as genotoxic impurities of Telmisartan that is marketed in a single pill combination. reversed phase‐high‐performance liquid chromatography method was developed using a C18 column Agilent (Zorbax C18; 250 × 4.6 mm internal diameter, 5 μm) along with 50 mM ammonium acetate (pH 4.5) and ACN as a mobile phase in gradient mode to achieve the retention of all analytes. The new method's sensitivity allowed the quantification of namely methyl benzene sulfonate, ethyl benzene sulfonate, and N‐methyl‐O‐phenylenediamine dihydrochloride at test concentrations as low as 0.025%. Amlodipine and Telmisartan each had a test concertation of 100 and 800 μg/ml, respectively. The developed analytical method was validated for different applications, that is, for assay and related substance methods. The calibration curves for genotoxic impurities were linear in the range of the Limit of quantitation to 1.2% of the test concentration of the respective drugs. Forced degradation investigations were conducted on selected drugs, and targeted analytes were then quantified. The stability of both drugs in acid and basic hydrolysis was improved compared to when they were evaluated separately, although Amlodipine showed an inverted degradation pattern in a more recent investigation when combined with Telmisartan under oxidative degradation conditions. The validated method was successfully applied for the quantification of the genotoxic impurities of Amlodipine and Telmisartan in finished pharmaceutical preparation. [ABSTRACT FROM AUTHOR]

Focuses on the transfer of biotechnologies under Article X of the Biological Weapons Convention. Principal elements of Article X; Requirements of the Trade Related Aspects of Intellectual Property Rights; Impact of the increase in the monopoly control of owners of technology.

The article focuses on the Asian Biotechnology Innovation and Development Initiative for biotechnology assessment and policy relevant indicators. It presents the definition of biotechnology-related terms included in the statistics 2006 report of the Organization for Economic Cooperation and Development (OECD). It notes the countries that launched data collection on the basis of the OECD definition. The issues surrounding the biotechnology data collection approach of nations are cited.

A letter to the editor is presented in response to an article related to the use of biologic materials in a previous issue.

The article offers information on a survey of entrepreneurial collaborations among health biotechnology firms in developing countries. According to the survey, though there is a high level of collaboration, there is also a lack of emphasis on new or improved health biotechnology products and processes. Countries included in the survey are Brazil, China, Cuba, Egypt, India, and South Africa and the number of firms surveyed is 467 wherein a total of 288 firms completed the survey. Survey authors recommend the integration of more South-South collaboration in their innovation policies and provide support for firms that want to promote innovation in health biotechnology.

A letter to the editor is presented concerning a survey on collaboration between the Southern and Northern hemispheres in the realm of biotechnology.

A correction to the article "South-South Entrepreneurial Collaboration in Health Biotech," that was published in the May 7, 2010 online issue of "Nature Biotechnology."