BIOSIMILARS: OPPORTUNITIES, CHALLENGES, AND THE GENERAL PRINCIPLES GOVERNING THEIR DEVELOPMENT AROUND THE GLOBE

Biologic drugs have revolutionized the treatment of many life-threatening and rare illnesses such as cancer and autoimmune diseases. Biologics are broadly referred as substances that are produced by living cells and are used in the treatment, prevention, or diagnosis of diseases. They include a wide range of substances, such as genetic material, antibodies, vaccines, or processes which act by influencing cellular processes that block disease or affect diseased cells. Biologics have become striking treatment options and the size of the market has grown hastily. It is expected that by 2023, most of the patents will expire in the European Union opening a large potential market. Keeping this in mind, the ability to launch substitutes to original biologics, also known as biosimilars, presents many opportunities to generic companies. The field of biosimilars seems to be “breaking” the traditional division between the creations of innovative NCE-based medicines by research-based companies, on the one hand, and, on the other hand, mapping of these medicines by the generic companies. The field of biosimilars so far presents some considerable challenges, namely, regulatory, safety, economic, and legal which are still being debated and discussed in different forums. In this article, we have tried to summarize the general principles and regulations governing the development of biosimilars by regulatory authorities such as the World Health Organization, European Medicines Agency, US Food and Drug Administration, and Health Canada. Furthermore, we have tried to throw some light on the opportunities, challenges, and current scenarios pertaining to biosimilars

Shell-model study of β+\beta^+/EC-decay half-lives for Z=21−30Z = 21-30 nuclei

In the present work, we have reported $\beta^+$/EC-decay half-lives for $Z = 21 -30$ nuclei using large-scale shell-model. %and N $\leq$ A recent study shows that some proton-rich nuclei in this region belong to the island of inversion. We have performed calculations for these nuclei using KB3G effective interaction, while for Ni, Cu, and Zn nuclei we have used JUN45 effective interaction in the $f_{5/2}pg_{9/2}$ model space. The calculated quenching factors for $fp$ and $f_{5/2}pg_{9/2}$ space using KB3G and JUN45 effective interactions are also reported. Shell-model results of $\beta$-decay half-lives, excitation energies, log$ft$ values, and branching fractions are discussed and compared with the available experimental data. We have obtained a reasonable agreement with the available data.Comment: 12 pages, 4 figures, 4 Tables, The European Physical Journal A : Hadrons and Nuclei (2023

The Study to Analyze the Impact of Green Supply Chain Management in India

Green supply chain management can be explained as a supply chain management system which is beneficial for the environment and which consists of designing of products , selection of raw material,manufacturing steps and delivery and preparation of final product through a stable and sustainable process.Sustainibility is the major key to supply chain ,which starts with the understanding through all the phases of production upto final distribution. This paper majorly focuses on the importance and need of term green and concepts or activities which are related to greener activities in areas like manufacturing and remanufacturing of products having a green impact ,controlling of travel costs and waste products , reverse logistics etc. The purpose is to understand the impact and also to make people aware about the major difficulties, problems and also the advantages and profits which are a part of such a great green concept if it is successfully implemented or installed during the process of supply chain management in various organisations.Keywords : Production, customer , supply chain , green , sustainability , manufacturing , materials

A large-deformation thermo-mechanically coupled elastic-viscoplastic theory for amorphous polymers : modeling of micro-scale forming and the shape memory phenomenon

Thesis (Ph. D.)--Massachusetts Institute of Technology, Dept. of Mechanical Engineering, 2010.Cataloged from PDF version of thesis.Includes bibliographical references (p. 185-193).Amorphous polymers are important engineering materials; however, their nonlinear, strongly temperature- and rate-dependent elastic-viscoplastic behavior is still not very well understood, and is modeled by existing constitutive theories with varying degrees of success. There is no generally agreed upon theory to model the large-deformation, thermo-mechanically coupled response of these materials in a temperature range which spans their glass transition temperature. Such a theory is crucial for the development of a numerical capability for the simulation and design of important polymer processing operations, and also for predicting the relationship between processing methods and the subsequent mechanical properties of polymeric products. We have developed a large-deformation thermo-mechanically coupled elastic-viscoplastic theory for thermoplastic amorphous polymers and shape memory polymers which spans their glass transition temperature. The theory has been specialized to represent the major features of the thermo-mechanical response of three technologically important thermoplastic amorphous polymers - a cyclo-olefin polymer (Zeonex-690R), polycarbonate, poly(methyl methacrylate) and a representative thermoset shape memory polymer - in a temperature range from room temperature to approximately 40 C above the glass transition temperature of each material, in a strain-rate range of ~ 10-4 to 101 s-1, and compressive true strains exceeding 100%. Our theory has been implemented in the finite element program ABAQUS. In order to validate the predictive capability of our constitutive theory, we have performed a variety of macro- and micro-scale validation experiments involving complex inhomogeneous deformations and thermal processing cycles. By comparing some key features, such as the experimentally-measured deformed shapes and the load-displacement curves from various validation experiments against corresponding results from numerical simulations, we show that our theory is capable of reasonably accurately reproducing the results obtained in the validation experiments.by Vikas Srivastava.Ph.D